ANZCTR search results

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

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33865 results sorted by trial registration date.
  • Intranodal forceps and cryobiopsy for acquiring tissue from mediastinal lymph nodes during endobronchial ultrasound transbronchial nodal biopsy: A Randomised Controlled Study

    This study aims to test the accuracy of two types of biopsy methods that is being proposed to get bigger sample of the lymph gland tissue used during the procedure. The first is by putting a pair of forceps (Intranodal Forceps Biopsy) through the airpipes into the lymph gland and removing a sample and the second is to put a freezing probe (Mini-Cryobiopsy) thought the airpipes into the lymph gland and removing a sample. We will compare samples we get using these techniques with what we usually do which is using a needle. Who is it for? You may be eligible for this study if you are male or female aged 18 years and older who are scheduled to undergo an EBUS procedure to biopsy enlarged lymph nodes in the chest (mediastinal and/or hilar lymph nodes). Study details All those who are eligible will undergo a standard EBUS procedure under general anaesthesia. During the procedure, tissue samples will be collected from the target lymph node using three biopsy methods: standard needle biopsy (EBUS-TBNA), intranodal forceps biopsy (EBUS-IFB), and mini-cryobiopsy (EBUS-MCB). All participants will receive all three biopsy methods. The order in which the forceps biopsy and mini-cryobiopsy are performed will be determined by chance (randomisation). The procedure is expected to take approximately 45 to 60 minutes and will be performed in the endoscopy unit of participating Australian hospitals. The collected tissue samples will undergo a range of laboratory tests, including cytology, histopathology, immunohistochemistry, molecular profiling, and, where required, microbiological testing and flow cytometry. It is hoped that this research will identify the most effective biopsy approach for diagnosing conditions that cause enlarged chest lymph nodes, helping patients receive an accurate diagnosis and appropriate treatment while reducing the need for additional procedures.

  • The Effects of Direct Current Stimulation Combined with Exercise on Mobility, Strength, and Balance in People with Multiple Sclerosis (MS): A Randomised Controlled Trial

    This study investigates whether adding pulsed direct current (DC) electrical stimulation, delivered via the Neubie device, to a supervised exercise program produces greater improvements in walking ability, strength, and balance in adults with Multiple Sclerosis (MS) compared with exercise alone. Forty participants will be randomly allocated to either 8 weeks of combined DC stimulation and exercise, or exercise alone. Assessments will occur at baseline, mid-intervention, post-intervention, and at a 6-week follow-up to determine whether any improvements are maintained over time. Findings will inform whether this combined approach offers a practical and effective rehabilitation strategy for people with MS.

  • Effect of a brief eLearning module on communication skills in cancer carers: A pilot randomised controlled trial

    Brief description of the study purpose: The study aims to evaluate whether a brief online education module can help cares of people with cancer feel more confident communicating with healthcare providers, improve their health literacy, increase their preparedness for carefiving, and support their psychological wellbeing. Who is it for? You may be eligible for this study if you are 18 years or older who provide support for someone currently receiving treatment for cancer, where the cancer diagnosis was made within the past three years. Participants must be able to read and speak English and have access to the internet and a digital device. Study details All eligible participants will be randomly assigned to one of two groups. One group will complete a 15-minute online eLearning module designed to strengthen communication and advocacy skills when interacting with the healthcare providers. The module includes interactive activities and audio-visual educational content and can be completed at the participant's own pace. The other group will continue providing care as usual and will not receive the training during the study period. All participants will complete online questionnaires at the start of the study, 2 weeks later, and 3 months later. The survey will assess factors such as communication confidence, health literacy, caregiving preparedness, psychological wellbeing, and experiences interacting with healthcare providers. Participants in the control group will receive access to the eLearning module after completing the final survey, and will not be assessed for impact of the module. It is hoped that this research will help identify effective ways to support cancer carers, enabling them to communicate more confidently with healthcare providers and improve the quality of care and support provided to people affected by cancer.

  • Let’s Grow+: A mHealth intervention to enhance nutrition and movement behaviours in toddlers.

    The Let’s Grow+ trial is designed to assess the efficacy, cost-effectiveness, and scalability of a mobile health intervention aimed at improving nutrition, physical activity, sleep, and reducing sedentary behaviour in toddlers. The intervention involves a 6-month mHealth program delivered via an app, including behaviour change techniques like goal setting and self-monitoring, supported by push notifications.

  • Subcutaneous injections of benzathine penicillin G (SCIP) for rheumatic heart disease in Boorloo

    People living with rheumatic fever and rheumatic heart disease are often recommended to have antibiotic injections at least every 28-days over five years to reduce their risk of permanent heart damage. Our team has developed a new, less painful, way to deliver the antibiotic, called ‘SCIP’, which provides 10-weeks of protection. By partnering with Derbarl Yerrigan Health Service, we will offer SCIP to people in need of regular BPG in Perth, Western Australia, and evaluate how well it works for them, with the ultimate goal of using SCIP to reduce rheumatic heart disease morbidity. We hypothesize that SCIP will provide an acceptable alternative way for people to get their regular BPG.

  • Variation between and within surgeons in the size and shape of the stomach after weight-loss sleeve gastrectomy, measured on three-dimensional CT scans

    When surgeons perform weight-loss sleeve gastrectomy, they remove most of the stomach to leave a narrow tube, but there is little agreement on what the ideal size and shape of the remaining stomach should be, and it is not known how much this varies between surgeons or changes over time. This study follows adults having sleeve gastrectomy with several different surgeons and uses three-dimensional CT scans of the stomach taken before surgery and again over the following five years to measure its size and shape in a standardised way. We will compare these measurements between different surgeons and within the same surgeon to see how much variation exists, and how the stomach changes over time. We will also look at whether these anatomical measurements relate to weight loss and to reflux symptoms. The aim is to define what a standard, well-constructed sleeve looks like, which could help make the operation more consistent and improve patient outcomes.

  • The effect of revision surgery (hiatus hernia repair, alone or with gastric bypass) on reflux in adults who have reflux after weight-loss sleeve gastrectomy

    Some people who have weight-loss (sleeve gastrectomy) surgery later develop troublesome acid reflux, and when medication does not control it surgeons can offer revision surgery: repairing a hiatus hernia on its own, or repairing it and converting the stomach to a gastric bypass. This study follows adults having this revision surgery as part of their usual care and measures whether their reflux improves. Before surgery and again afterwards we compare each patient's acid-reflux test results (pH monitoring) and their reflux symptom (Visick) scores, and we record any complications, whether anti-reflux medication is restarted, and satisfaction with surgery. There is no separate control group; each participant acts as their own comparison, and we also compare the two revision approaches. We expect revision surgery to reduce both acid exposure and symptoms, which will help patients and surgeons choose between the two revision options.

  • Supporting pre-service teachers’ holistic health during their final in-school teaching placement

    The aim of this project is to support pre-service teachers’ holistic health during their final in-school teaching placement. Non-controlled trial The studies hypothesis is that by participating in physical activity and zooms the pre-service teachers may have better physical activity patterns, mental health and social support whilst on placement.

  • Shared Medical Appointments for Women Living with Endometriosis: a Feasibility Study

    This project is piloting Shared Medical Appointments (SMAs) — group-based sessions that bring together individual clinical care, education, and peer support — for women with endometriosis at the WSIH MyHealth Integrative Medical Centre in Western Sydney. We will test this program to see how well it works and whether people find it helpful and easy to take part in. What we learn will help us create ongoing group integrative SMAs for women with endometriosis at WSIH MyHealth, including programs tailored to specific cultural groups. It will also help guide similar group programs for other women's health conditions.

  • Psilocybin-assisted treatment for methamphetamine use disorder: A multi-site randomised controlled trial (PsiMA RCT)

    This is a phase 2b, multi-centre, double-blind randomised controlled trial evaluating psilocybin-assisted psychotherapy (PAT) for methamphetamine use disorder (MAUD). One hundred and twenty treatment-seeking adults with MAUD will be randomised 1:1 to receive either PAT with a single 25 mg oral dose of psilocybin or PAT with a single 5 mg oral dose of psilocybin, with both groups receiving the same structured preparatory and integration psychotherapy. The primary outcome is the number of days of methamphetamine use in the 28 days prior to week 12 post-randomisation, assessed using Timeline Follow Back methodology and supported by urine drug testing. Secondary outcomes include methamphetamine abstinence and remission, other substance use, craving, mental health, sleep, quality of life, functional impairment, safety, acceptability, feasibility and cost-effectiveness. Participants will be followed to 52 weeks, with an optional open-label 25 mg psilocybin-assisted psychotherapy treatment offered after the week 16 assessment.

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