ANZCTR search results

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

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32712 results sorted by trial registration date.
  • Chest Australia: reducing time to consult with symptoms of lung cancer.

    This study is evaluating the effect of an intervention aimed at promoting earlier symptom appraisal and help-seeking for people at higher risk of lung cancer. Who is it for? You may be eligible to join this study if you are aged between 55-90 years and have smoked at least one packet of cigarettes daily for a period of 20 years (i.e. 20 pack years). This includes ex-smokers if your cessation date was less than 15 years ago. Trial details: Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants in one group will receive standard care, whilst participants in the other group will be offered the CHEST intervention. This is theoretically based and comprises a 40 minute primary nurse consultation to discuss and implement a self-help manual, followed by monthly self-monitoring reminders by either, email, text message or phone call. Participants will be monitored for 12 months to evaluate the effect of the intervention on consultation rates and time to consultation for chest symptoms.

  • Comparing the use of a needle guidance device with free-hand technique in performing ultrasound-guided transversus abdominis plane (TAP) blocks: a prospective randomized trial.

    This study is designed to determine whether the use of the CIVCO (Registered Trademark) ultrasound needle guide (Infiniti, CIVCO Medical Solutions, Kalona, Iowa, USA) will improve visualisation of the needle tip during ultrasound-guided TAP blocks when compared with the “free hand” technique for patients undergoing major abdominal surgery. Furthermore, we aim to study whether it will shorten the procedural time, improve operator satisfaction or lead to increased dermatomal blockade.

  • Application of Integrated Disease Self-Management in Type 2 Diabetes Mellitus

    This project will evaluate an integrated 'chronic disease self-management' (CDSM) education program for people with type 2 diabetes mellitus. The program is constructed around a patient manual, the working through of which is facilitated by a trained health coach over a 7 week period. The manual provides key information about disease management and skills training. Using the "Whole Person Model" the manual encourages the reader to consider how their body, their thoughts and feelings, and their health behaviours all affect each other. It helps people look at their thinking and learn strategies to improve their mood and make lifestyle changes. The aim of the proposed project is to evaluate, through a randomised controlled trial, the efficacy of the program. It is hypothesised that people allocated to the intervention (completion of the program) will demonstrate greater improvements in self efficacy in their disease management, health outcomes, well-being and quality of life than the control group.

  • Telerehabilitation: A novel approach to the provision of Heart Failure Rehabilitation Programs

    This randomised controlled trial will evaluate the effectiveness of a 12-week heart failure rehabilitation program that is delivered into the homes of patients via telerehabilitation (Telerehabilitation Group) compared to a 12-week program delivered in the face-to-face manner (Conventional Group).

  • High Flow Nasal Cannula Treatment for Viral Bronchiolitis in Infants, a Randomised Controlled Trial

    Bronchiolitis is the leading cause of paediatric hospitalisation in Australia accounting for approximately 8000 admissions annually, of which approximately 500-600 are admitted to a paediatric intensive care unit (PICU) requiring respiratory support. There have been numerous attempts and studies over the last three decades investigating the roles of steroids, salbutamol, adrenalin and inhalation of hypertonic saline in infants with bronchiolitis. None have successfully changed the outcome of the disease or the burden on health care systems. High flow nasal cannula (HFNC) therapy has been used over the last 8 years in paediatrics with reports showing a reduction in the need for non-invasive and invasive ventilation. HFNC reduces the work of breathing, improves the gas exchange and can be applied very early in the disease process as there is little interference with the patients comfort. Despite the existing data, the uptake of HFNC therapy in paediatrics is sporadic. This is, in part, due to a lack of “best practice”. Similarly, many centres do not use the HFNC for bronchiolitis as there are opposing report about its benefit and a lack of consensus on how to use it. This study aims to develop a multi-centre trial and to assess which patients with bronchiolitis benefit using HFNC. For this purpose we will perform a randomised controlled trial comparing current best practice versus HFNC therapy. With the introduction of this simple to use respiratory system in regional hospitals we aim to reduce the need to transfer infants with bronchiolitis to tertiary centres.

  • Phase II Feasibility Study of Gold Fiducial Markers for Surgical-Pathological Localisation and Chemotherapy Response Assessment in the Multi-Disciplinary Team Management of Oesophageal-Gastric Cancer

    This study is examining whether inserting gold markers (known as fiducial markers) into a tumour may aid surgical and chemotherapy response assessment in patients with oesophageal-gastric cancer. Who is it for? You may be eligible to join this study if you are aged over 18 years and have been diagnosed with biopsy proven primary (non-recurrent) squamous cell carcinoma (SCC) or adenocarcinoma of the stomach. Trial details: All participants in this trial will have 2-4 tiny gold markers (known as fiducial markers) inserted into the tissue beside their tumour during endoscopy. Endoscopy involves having a tube inserted into the back of the throat and takes about 30 minutes. Each gold marker is approximately the size of a grain of rice (1mm x 3mm). Having gold seed locators makes it easy for the surgeon or the radiotherapist to know exactly where to operate or irradiate because they show up clearly on the PET Scan, CAT Scan and Radiation Treatment machine. If the tumour shrinks very well with chemotherapy then the Pathologist may not know exactly where to find the tumour in the tissue removed. This can make it very difficult to provide a precise report and hence the need for any follow-up treatment after surgery. This study will not affect routine treatment in any other way. We wish to study approximately 20 patient’s scans and pathology reports to see exactly how much improvement we get in correlating these gold markers with scan results. At the moment there is no good information to show that they consistently improve accuracy of treatment for stomach and oesophageal tumours. We have good information over the last 40 years that gold marker seeds improve accuracy in Head and Neck Cancer and Cervical Cancer. Over the last 10 years they have become indispensable in Breast Cancer (titanium markers rather than gold) and particularly in prostate cancer radiotherapy, where gold seeds have reduced radiotherapy side effects massively in tens of thousands of men worldwide. Based on this information we expect that there will be benefits in the stomach and oesophagus as well.

  • Safety, tolerability, food effect and pharmacokinetics of FT011 in healthy volunteers and patients with Type 2 diabetes-associated diabetic nephropathy

    This study will assess the safety and PK of the oral drug FT011 in healthy volunteers and in a small number of patients with diabetic nephropathy due to type 2 diabetes mellitus. Results from this study will help determine the development of FT011 as a treatment for diabetic nephropathy.

  • Radiotherapy, Ipilimumab and Nivolumab in Metastatic Melanoma.

    This study is examining the safety and biological effects of combining Ipilimumab and radiotherapy, or combining Ipilimmab, Nivolumab and radiotherapy in patients with metastatic melanoma. Who is it for? You may be eligible to join this study if you are aged over 18 years and have been diagnosed with advanced melanoma stage IIIc or IV. Trial details 6 participants in this trial will undergo 5 daily doses of radiotherapy during week 1. They will also receive Ipilimumab at a dose of either 3mg/kg or 10mg/kg at weeks 1, 4, 7, and 10. This drug will be administered intravenously (i.e. directly into the vein) over a period of 90 minutes. 24 patients in this trial will undergo 5 daily doses of radiotherapy during week 1. They will also receive Nivolumab at a dose of 1,g/kg together with Ipilimumab at a dose of 3mg/kg at weeks 1, 4, 7 and 10. This group will also receive Nivolumab 3mg/kg every 2 weeks after as maintenance. These drugs will be administered intravenously (i.e directly into the vein). Participants will be reviewed for up to 24 months in order to determine treatment toxicities, tumour response, and immune response.

  • A randomised trial to compare post-operative respiratory function following bolus abdominal block local anaesthesia, versus standard infusional abdominal block local anaesthesia in patients undergoing gastrointestinal resectional surgery

    The study is trying to find out which is the best way to deliver a medication for pain relief called a local anaesthetic (a drug that helps to numb areas of the body e.g. the skin) to the abdominal wall in patients undergoing major abdominal surgery in order to help reduce the post-operative pain.

  • The relationship between limb length discrepancy and Foot Posture Index (FPI).

    The study aims to evaluate the effect of an LLD (Limb length discrepancy) using a modern measure of foot position; the Foot Posture Index (FPI).

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