ANZCTR search results

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

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31112 results sorted by trial registration date.
  • Management of paediatric donor sites of split-thickness skin grafts with Suprathel: a randomised control trial

    Split-thickness skin grafts are routinely used to manage burns that are unlikely to heal with dressings alone. The skin graft is taken from a donor site, for example the thigh, creating a donor site wound. Treatment of this donor site wound has an impact on the total recovery and rehabilitation of the patient. Multiple dressings have been investigated for the management of the donor site wounds, including biobrane, calcium alginate, acetate guaze and gauze mesh. However, despite previous research the optimum dressing for donor site wounds remains unclear. Suprathel is an artificial substitute skin dressing that is commonly used on burns and graft site wounds. The paediatric surgeons at The Townsville Hospital have observed that Suprathel also has positive results when used on the donor site wound. Therefore, we propose to investigate the management of paediatric donor site wounds of split-thickness skin grafts with Suprathel in a randomised controlled study. We plan to compare the use of Suprathel with jelonet, a commonly used dressing on the donor site. Participants: Children 16 years or under requiring a clinically indicated split thickness skin graft Expected outcomes: Identifying whether Suprathel is superior to a commonly used dressing on paediatric donor sites.

  • A pilot gender-sensitised lifestyle intervention for overweight men targeted at physical activity, diet, and mental health

    Physical activity, diet, and mental health practices play an important role in chronic disease prevention and management. Underrepresentation of men in healthy lifestyle programs tells us that more can be done to engage men and support them in making healthy lifestyle changes. The aim of this study is to develop and test a lifestyle intervention for men living in Australia aimed at improving the physical activity, diet, and mental health of those at an increased risk of chronic disease (i.e., overweight weight, inactive, insufficient fruit and vegetable consumption). We believe that men in the HAT TRICK intervention group will show greater improvements in a) physical activity, b) diet quality, c) risk of depression scores, d) physical fitness, and e) anthropometrics at 3 months post-baseline, compared to a wait-list control group.

  • A pilot randomised waitlist-controlled study investigating a psychosocial life skills program called Thrive, for young adults 18 to 25 years with chronic illness.

    This study will evaluate the effectiveness of a psychosocial life skills program by measuring improvements in quality of life (standard of health, comfort and happiness), social connectedness (the relationship people have with others), and perceived stress (the degree to which situations are seen as stressful). Participants will be randomised into one of two groups; the intervention (being the Thrive program attendees who consent to take part in the study) or the waitlist-control (people waiting to be enrolled in a Thrive program).

  • A Healthy Volunteer Study Evaluating the Tolerability and Pharmacokinetics of PRN473 Topical

    The purpose of this research study is to assess the safety and tolerability of PRN473 Topical as well as the pharmacokinetics (PK - how your body absorbs medications). We are doing this study in healthy men and women to find out: • Does the drug have any side-effects and is it well tolerated when given topically as a single dose and in multiple doses? • How much of the drug when given topically gets into the blood stream, and how long does the body take to get rid of it? This study will compare PRN473 Topical with placebo. A placebo has no active drug in it. One group of participants will receive PRN473 Topical and another group will receive the topical placebo. The effects seen in participants receiving the study drug will be compared to the effects seen in participants who receive the placebo. This study will look at how participants react to, and how the human body uses PRN473 Topical at different dose levels. In total there are planned to be 2 parts to the study. Part A will look at the effects of a single topical dose of the study drug and Part B will look at the effects of multiple topical doses of the study drug

  • Distinguishing Gastroesophageal Reflux Disease and Eosinophilic Esophagitis in Adults: the Role Esopahegal Mucosal Immunoglobulin IG4

    Background: Eosinophilic esophagitis (EoE) and gastroesophageal reflux disease (GERD) can be difficult to distinguish as many of their clinical and histological features overlap. Preliminary data suggests a potential association between EoE and immunoglobulin G4 (IgG4), but not GERD. Aim: To examine the role of esophageal mucosal IgG4 staining in differentiating EoE from GERD. Methods: Esophageal biopsy specimens from patients with proven EoE and GERD were evaluated and immunohistochemical staining for IgG4 was performed by an experienced gastrointestinal pathologist blinded from the clinical and endoscopic data. The results on IgG4 staining was then correlated with clinical, endoscopic and histological features.

  • Stomach distension with high flow nasal oxygen therapy. A volunteer study

    High flow nasal cannula (HFNC) has been shown to provide better oxygenation compared to the venturi face mask and low flow nasal cannula during intravenous sedation for both bronchoscopy and dental procedures . Though there are no major effects reported with this device, gastric distension is a theoretical possibility. Continuous high flow together with the ability to create low levels of positive airway pressure can potentiate gastric distension. When gastric distension occurs, it causes an increase in the secretion of gastric acid through vagal response. Hence, there is a potential for increased gastric volume and secretions, along with an elevated intraluminal pressure. This may increase the risk of pulmonary aspiration of gastric contents. Data is lacking as to quantify this issue in clinical practice. The aim of this study is to assess gastric insufflation and volume in healthy volunteers after application of HFNC. We hypothesise that the application of high flow nasal oxygen will not result in gastric distension. Measurements will be made of the incidence of gastric insufflation before and after the application of HFNC. When the participants are ready, a baseline ultrasound estimate of the stomach volume estimate is done. Thereafter, oxygen will be delivered through a high-flow nasal cannula. This will be accomplished using the Optiflow THRIVE device (Opti-Flow, Auckland, New Zealand). Flow rate through the cannula will be commenced at 30 L/min and fractional inspired oxygen concentration will be set at 100%. The flow will be gradually increased and maintained at 60-70L/min during the study. The flow rate could be decreased up to 30 L/min if higher flow rate is not tolerated. A set of ultrasound measurements looking for gastric distension and antral area will be made at 10 minutes intervals till 30 minutes of HFNC delivery. Measurements will be obtained between peristaltic contractions when the stomach is resting. A set of three measurements will be made for each outcome variable and the mean value would be recorded. The HFNC will be ceased at 30 minutes and the participants are allowed to rest for another 30 minutes. During this time, they are not allowed to eat or drink. Another set of scans and measurements will be obtained 30 minutes after ceasing HFNC.

  • A prospective single arm paired comparison of ability to locate and diagnose prostate cancer between multiparametric MRI, PSMA-PET/CT AND PSMA-PET MRI fusion

    The purpose of this study is to compare a new imaging technique (called 18F-DCPYL-PET/CT) to standard imaging. Who is it for? You may be eligible for this study if you are a male aged 18 or older and are due for imaging to see if you have prostate cancer. Study details All participants in this study will have two scans. One is a multi-parametric magnetic resonance imaging (mpMRI) scan, which is the standard imaging technique used. The other scan is a Positron Emission Tomography (PET) scan, which will be combined with a technique called computed tomography (CT). The PET scan required injection of a chemical called 18F-DCPYL, using a needle in the arm. Researchers will use the results of these scans to see if the 18F-DCPYL scan is as useful as the mpMRI. As part of the study, participants will consent to access medical records, in addition to the scans. It is hoped this research will demonstrate the 18F-DCPYL scan can improve our ability to detect prostate cancer.

  • How well do tests that measure gluten in the faeces detect low-level dietary gluten exposure in people with coeliac disease?

    Achieving optimal health for people with CD requires a strict gluten free diet. Unfortunately, accidental gluten intake is common. Assessing for gluten intake based on dietitian evaluation or coeliac serology lacks sensitivity and small intestinal histology requires an invasive test. This study will assess a new test that measures gluten (gluten immunogenic peptides) in a faecal (stool) sample. Participants will consume a gluten-free cookie containing either a small amount of gluten (equivalent to a “real-world” contamination) or placebo and their faeces assessed. The study will inform how this objective test can be deployed in clinical practice to support people following a strict gluten free diet.

  • A Study Assessing Delivery Of Prone Radiotherapy As A New Technique To Minimise Patient Toxicity In Patients With Invasive Breast Cancer

    This study aims to determine the best way of delivering radiation therapy to the breast tissue before surgery. In order to do that, women will lay in a prone position (on the stomach), so that the breast can fall naturally forward and away from the chest. The cancer inside the breast tissue is treated to a very high dose before it is removed. The aim is to minimise skin toxicities to help the surgeons perform the operation and reconstruction, all in one surgery. Who is it for? You may be eligible to join this study if you are aged 18 years or older and have a histologically confirmed invasive, Grade 1, 2 or 3 breast carcinoma with a Primary tumour graded as T2, T3 or T4 and N1+. Study details This study will take about 1 year to recruit 20 participants suitable for radiotherapy in the prone position. On average, the total study duration is expected to be 3 months for each participant. Radiotherapy treatment will commence at least 4 weeks after completion of standard chemotherapy and it will be delivered in the prone position, five days a week from Monday to Friday, over 5 weeks (25 fractions, 2Gy/fraction). One week before the radiotherapy treatment, the Radiotherapy Planning will be booked and the session will take approximately 1 hour. During the study, clinical assessments will be performed once a week during the treatment and then 2 and 4 weeks after radiotherapy completion. Each visit will take approximately 1 hour. 4-8 weeks following successful completion of radiotherapy participant will have a surgery to remove the breast and immediate breast reconstruction. 30 days after the surgery each patient will have their last study visit - post surgical assessment to evaluate any side effects and surgical complications. It is hoped that information from this study may help improve the treatment for other patients with invasive type of breast cancer in the future and will help evaluate the new position and treatment doses for future breast radiotherapy treatment.

  • Evaluating the acceptability and impact of Smileyscope in the Kimberley region for Aboriginal children, their families, and health professionals.

    Evaluating the impact of the Smileyscope will assist participating health services in determining the ongoing adoption of the technology for routine clinical use. The evaluation will also inform other Kimberley health services about the impact and acceptability of Smileyscope for Aboriginal children, their families, and their healthcare professionals helping to create regional discussions and approaches to paediatric needle pain and anxiety management.

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