ANZCTR search results

Incontinence associated dermatitis (lAD) is a preventable skin condition in the bottom and genital area due to exposure to moisture and other irritants. lt is characterised by patchy inflammation of the skin and eventually leads to skin erosion. The patient may experience itching or burning sensations and/or pain and can suffer a decrease quality of life. lAD results in complications including increased risk of developing a pressure injury or a skin infection. As a result, lAD associated complications can be expensive for healthcare services. This study intends to evaluate the effectiveness of 3M Cavil on TM Advanced Skin Protectant to prevent, delay and/or reduce the severity of lAD, in critically ill patients in the intensive care setting. This pilot study aims to enroll 30 eligible study participants who have been appropriately consented and screened. The interventional product will be administered three times a week, with the control product (standard treatment) administered daily whilst the participant is in the intensive care setting. Study participants will be assessed at baseline, Day 1 then daily or three times a week with evaluations including demographics, product application, skin assessment and completion of questionnaires. In addition the incidence and severity of adverse events and performance of the interventional product will be documented.

A prospective multi-center study of adult patients admitted to intensive care (ICU) or high dependency unit's across Victoria. Ethical approval will be sort through The Alfred Hospital, Monash University and the individual ethics boards for each participating site. This study aims to use anchor and distribution based methods to establish the minimal important difference (MID) of the ICU mobility scale (IMS) in a critically ill population. Anchor based: Where patients are treated by the same clinician physiotherapist within 24 hours of admission and discharge to ICU they will be asked two questions on the final assessment. “Has the patient’s mobility changed since admission to ICU?” and “If yes, how much have they changed?’ The rate of change will be scored as: 1- almost the same, hardly better at all, 2- a little better, 3- somewhat better, 4- moderately better, 5- a good deal better, 6- a great deal better and 7- a very great deal better. Similar assessments will be made for deterioration, substituting “worse” for “better”11. The IMS will also be independently collected at both time points by a clinical researcher. Distribution based: The patients’ IMS scores from ICU admission and discharge will be used to estimate the MID using two distribution based methods, the standard error of the mean and the effect size.

This clinical trial aims to evaluate the safety and tolerability of 2 different pirenzepine formulations after daily topical dose administrations in healthy subjects for 14 days and of an alternative dosing regimen in healthy subjects with 1 of the pirenzepine topical formulations. The secondary purposes of this trial are to evaluate the pharmacokinetics (PK) of pirenzepine and its desmethyl metabolite following single and multiple topical doses of 2 different pirenzepine formulations and to evaluate the PK of pirenzepine and its desmethyl metabolite following an alternative dosing regimen with 1 of the pirenzepine topical formulations.

The primary purpose of this trial is to evaluate the feasibility of implementing standardised early palliative (STEP) care for advanced breast, prostate and brain cancer patients. Who is it for? You may be eligible to enroll in this trial if you are aged 18 or over and have been diagnosed with prostate cancer with metastases, breast cancer with at least one visceral metastasis or grade IV brain tumour/glioblastoma with recurrent disease or no cancer treatment prescribed, and their nominated carer. You must have been admitted to hospital for a stay lasting more than one day in the previous two weeks. Study details All participants enrolled in this trial will be randomly allocated (by chance) to receive either standard care or to receive the STEP care intervention in addition to standard care. Participants allocated to the STEP care intervention will receive palliative care consultations (with their carer) at least once per month for three months. If the treating doctor/nurse determines that further palliative care would be beneficial then another three months of consultations may be provided. The palliative care is tailored to the needs of the person and their carer, but will include review and management of any symptoms of concern, referral for additional supports as required, review of informational needs, addressing illness understanding and discussion of prognosis, assistance with care planning, case conference with the person's GP. Researchers will monitor whether the implementation of this program, and whether recruitment into this trial are feasible, as well as asking all participants to complete a number of questionnaires to determine whether the STEP care intervention benefits patient and carer outcomes such quality of life, mood, and survival and reduces time spent in hospital. It is hoped that the results of this pilot trial will inform a future large scale trial to evaluate whether standardised early palliative care is beneficial for advanced cancer patients and their carers.

Test null hypothesis: there is no difference in pocket depth reduction, between one stage full mouth disinfection with and without the use of adjuvant systemic antimicrobial therapy (Azithromycin) against the alternative hypothesis of a difference. AIM :The purpose of this study will be to evaluate the use of systemically administered azithromycin as an adjuvant to OSFD (one stage full mouth disinfection) in the treatment of chronic periodontitis through clinical and microbiological periodontal parameters at baseline, 90 post therapy. SIGNIFICANCE OF THE RESEARCH - Although general consensus favours the use of systemic antibiotics in conjunction with conventional staged debridement therapy in treatment of advanced periodontal diseases, there are limited studies where systemic antimicrobials were used in conjunction with one stage full mouth disinfection. To the best of our knowledge, there are no studies that evaluated clinically or microbiologically the use of azithromycin as an adjuvant to the OSFMD. This trial could help provide evidence based guidelines for the use of azithromycin in conjunction with OSFMD in treatment of patients with chronic periodontitis.

Approximately 17000 colonic cancers are diagnosed in Australia each year. The majority of patients will undergo surgery. Large sessile lesions are traditionally removed surgically. In recent years advances in Endoscopic Mucosal Resection (EMR) emerged as a safe, effective, minimally invasive technique for removal of large sessile polyps and can be performed as an ambulatory procedure in special Gastroenterology units. This has potentially a much smaller impact on the patient and allows a faster recovery. However, one of the main risk factors of EMR is delayed bleeding. Clinically significant post-endoscopic bleeding [CSPEB] occurred in 6.2% of patients. The underlying cause for the bleeding is unclear. We suspect that there is a possibility the clotting system gets disturbed slightly during the procedure in some patients. A special blood test looking for clotting abnormalities may help us evaluate if this theory is true or not. This study will test for clotting abnormalities before and after endoscopic mucosal resection (EMR). Who is it for? You may be eligible to join this study if you are aged 18 years or above and are undergoing EMR for large sessile colonic polyps. Study details All participants will have a blood test immediately before and after the EMR to check for clotting abnormalities. Participants will be asked to return to the clinic for post-procedure follow-up 2-3 days after the procedure to determine any occurrences of post-endoscopic bleeding.

Parkinson’s disease (PD) is a chronic, progressive, incurable, and disabling neurological condition. In addition to the many physical symptoms at least 75% of people with PD experience impaired speech production and various mental health issues, such as depression and anxiety. This mixed-methods study aims to explore the experience of group singing for people with PD and examine the effects of long-term participation on communication and health outcomes. We will assess speech and voice function, speech-related quality of life, and communication participation, as well as wellbeing outcomes such as depression, anxiety and fatigue for both participants with PD and their caregivers.

The study is a randomised controlled treatment (RCT) trial over 8 weeks in individuals with Major Depressive Disorder, with a 6 month post-RCT trial period, where study participants have the option to continue Vortioxetine. The purpose of the study is to investigate the effectiveness of using a simple blood test, prior to treatment of depression, to guide the use of anti-inflammatory medication as an addition to antidepressant medication. The study aims to find out whether adding the anti-inflammatory medication Celecoxib (also known as Celebrex) to the antidepressant medication Vortioxetine (also known as Brintellix) can improve symptoms of depression. There is evidence that raised levels of inflammatory markers in the blood are associated with depression. The study measures the inflammatory marker C-reactive protein (CRP) prior to commencing treatment, with study participants assigned to a study "arm" based on CRP levels. Within each study "arm", participants receive treatment for 6 weeks, with either Vortioxetine plus Celecoxib, or Vortioxetine plus placebo. Levels of circulating inflammatory markers, tests of cognitive function, and depression symptoms are measured at baseline (before treatment) and again at the end of this 6 week treatment period.

The primary purpose of this trial is to evaluate the efficiency of two endoscopic imaging techniques for detecting colonic adenoma during colonoscopy. Who is it for? You may be eligible to enroll in this trial if you are aged 18 or over, and are scheduled to undergo a colonoscopy. Study details All participants enrolled in this trial will receive colonoscopy using both standard white light (WL) and linked colour imaging (LCI). LCI is a new endoscopic image enhancement technology that is built-in within scopes and activated by a push-button and highlight mucosal abnormalities within the gastrointestinal lumen. LCI uses different band widths and filters and is hypothesized to improve detection of subtle gastrointestinal pathology. Participants will be randomly allocated (by chance) to receive WL imaging first, followed immediately by LCI to detect any polyps missed by WL, or to receive LCI imaging first, followed immediately by WL to detect any polyps missed by LCI. This will allow researchers to investigate which technique results in less missed adenomas during colonoscopy.

A ‘hybrid closed-loop (HCL)’ system or ‘hybrid artificial pancreas’ provides automated control of basal insulin delivery, with ongoing requirements for manual boluses of insulin for meals. These systems offer the potential to reduce significant glycaemic excursions outside of a healthy glucose range compared with standard therapy. Small, short-term pilot studies have shown superior glucose control and lower rates of hypoglycaemia with use of a hybrid artificial pancreas compared with manual insulin delivery. Closed-loop insulin delivery has the potential to revolutionise type 1 diabetes therapy. The primary study rationale is to fill a knowledge gap regarding the efficacy of glucose control with long-term use of an HCL system vs standard manual insulin therapy, including % time in target glucose range, as well as glucose excursions (both hypoglycaemia and hyperglycaemia). This study will explore the impact of the HCL system on fear of hypoglycaemia, treatment satisfaction, psychological outcomes, sleep quality and cardiac rhythm, and the economic impact of using HCL. Any improvement in glycaemia may also be reflected in biomarkers associated with the risk for long-term complications of diabetes. One sub-study will explore the efficacy of the HCL system vs. standard therapy in regards to hypoglycaemia awareness and the counter-regulatory hormone response to hypoglycaemia of participants with severe hypoglycaemia and impaired hypoglycaemia awareness. A second sub-study will compare glucose control with different types of exercise using the HCL system vs. standard therapy.