ANZCTR search results

Extensive research suggests that high levels of perfectionism are associated with various mental health issues and that many university students possess perfectionistic traits. This study aims to assess the feasibility of Intentional Imperfection, an educational resource for university students that targets consequences of perfectionistic behaviours based on the Perfectionism Social Disconnection Model. Eligible participants must be aged 17 or above and score 36 or above on the Clinical Perfectionism Questionnaire. Eligible participants will complete several baseline measures followed by engagement with the educational resource, which teaches emotion regulation strategies, social skills, and relationship goal setting. Participants will be contacted two weeks later to a complete post-intervention assessment and a feedback survey. We expect engagement with the resource will increase participants interpersonal, cognitive and emotion regulation skills, and decrease rejection sensitivity, interpersonal hostility, actual/perceived social disconnection and thus risk for psychopathology.

Pliant Inc. is developing PLN-74809-000 (hereafter referred to as PLN-74809) for the treatment of idiopathic pulmonary fibrosis (IPF) and for the treatment of primary sclerosing cholangitis (PSC). PLN-74809 is expected to exert anti-fibrotic effects through mechanisms that are different from those of current standards of care for the treatment of IPF. IPF remains a clear area of unmet medical need, warranting the development of novel therapies aimed at providing a clinically meaningful improvement for the IPF population. An oral solution of PLN-74809, which has been used in the clinical studies conducted thus far, is to be replaced by a newly developed tablet formulation. Accordingly, the current study is designed to determine the relative bioavailability of the tablet vs the solution as a reference in healthy participants.

This Is a First In Human Phase 1 Single Center, Randomized Double-Blind, Placebo-Controlled Study To Evaluate The Safety Tolerability And Pharmacokinetics of MultipleE Ascending Doses of AUM001 In Normal Healthy Volunteers This study will evaluate the safety, tolerability and pharmacokinetics of multiple ascending doses of AUM001 in healthy volunteers. You may be eligible to join this study if you are aged 18 and above and below 50, are healthy with no active or chronic diseases/disorders Participants in this study are randomly allocated (by chance) to one of two groups in one of three cohorts in ascending doses Safety, tolerability and pharmacokinetics will be assessed at regular intervals using clinical examinations and blood tests. This study is not open to cancer patients, and should not be promoted as such. Recruitment will be restricted to those volunteers identified as fitting the selection criteria by the Phase I Clinical trial Unit. his is a healthy volunteer study. It is proposed that the drug will be evaluated for the treatment of patients with a range of solid and liquid tumours"

The primary objective of this study is to evaluate Shift, a novel smartphone application designed to support the mental health and wellbeing of Junior Medical Officers in New South Wales. This will be the first app of its kind, in that it is specifically designed for doctors in training who would like to learn about how to improve or maintain their mental health while entering the workforce in the demanding medical profession. The app uses therapeutic elements (cognitive-behavioural, mindfulness, and psycho-educational contents) designed to alleviate or prevent the worsening of mental health symptoms and encourage help-seeking behaviours.

Patients admitted to hospital requiring intravenous corticosteroids for management of their ulcerative colitis will be prospectively recruited for this observational study. The medical management of the patient in hospital and timing of further investigations will be guided by the treating clinician and not by the study investigators. Patients specific treatment in hospital will be recorded. Blood tests, which are part of routine care will be recorded daily. The clinical symptoms of the patient will be recorded daily with a standardised clinical tool. Furthermore, we will collect faecal calprotectin as part of the biochemical screening. The results of the inpatient flexible sigmoidoscopy or colonoscopy will graded with validated endoscopic assessment scores. The findings of the endoscopic assessment will be blinded to the clinicians performing the gastrointestinal ultrasound (GIUS) assessment. GIUS is a non invasive ultrasound assessment that can accurately detect disease activity in inflammatory bowel disease, including patients with ulcerative colitis. The GIUS assessment will be detailed looking at the standard features used to assess disease activity in IBD such as bowel wall thickness, colour Doppler, wall stratification assessment, haustration assessment and extra intestinal features of inflammation. GIUS will occur within 24 hours of IV corticosteroid initiation and at 48 hours. If the patient remains in hospital at 7 days, the GIUS will be repeated. Follow up will occur at 2 weeks, and then 3 monthly up until 1 year. The aim is to predict if gastrointestinal ultrasound findings can predict the treatment course of admitted patients ie. steroid responsive individuals vs. steroid non-responsive (patients requiring salvage therapy).

This is a substudy of the Cancer Molecular Screening and Therapeutics (MoST) Program, which is registered on ANZCTR with ID ACTRN12616000908437. This substudy will evaluate the activity of combination of palbociclib and avelumab after initial priming with palbociclib in patients with advanced cancer with eligible mutations of the following: 1. Gain-of function mutations in CDK4 and CCND1-3 2. CDKN2A deletion or loss-of-function mutations Who is it for? You may be eligible to join the study if you are aged 18 years and older, with pathologically confirmed advanced and/or metastatic solid cancer of any cell type or an earlier diagnosis of a poor prognosis cancer and have received all standard anticancer therapy. Participants will have tumours with gain-of function mutations in CDK4 and CCND1-3, or CDKN2A deletion or loss-of-function mutations. Study details Participants will receive palbociclib on its own in the first cycle. Palbociclib will be taken orally at a dose of 125 mg once daily for 21 days, followed by 7 days of washout. Participants will then start to receive avelumab at a dose of 10 mg/kg every 2 weeks from the second cycle of treatment. Both palbociclib and avelumab will be given to participants continuously as long as they and their doctor agree there is a benefit from treatment. Participants will undergo imaging assessments at 8 weekly intervals for the first 24 weeks and then every 12 weeks until progression. Safety and tolerability of treatment will be assessed at 4 weekly intervals. Health related quality of life during treatment will be assessed at 8 weekly intervals for the first 24 weeks and then every 12 weeks until progression. We cannot guarantee that patients will receive any benefits from this study. This study is being carried out to improve the way we treat cancer patients who may have limited treatment options available to them. It is hoped that T-DM1 will be well tolerated and will improve outcomes for future patients, however, there may be no clear benefit from participation in this study.

The aim of this study is to accelerate the implementation of treatments to reduce the burden of morbidity and mortality due to severe respiratory disease in people with COVID-19. Who is it for? You may be eligible to join this study if you have a confirmed diagnosis of COVID-19, are aged 18 years or more, and do not have clinical features of severe respiratory disease or require inpatient care. Study details Participants in this study will be randomly allocated (by chance) to a treatment group. Treatments will be added during the course of the trial and will only commence once necessary approvals have been obtained. All participants will be monitored for various events, such as hospital admission, ICU admission, mechanical ventilation, fever, symptoms and adverse events. It is hoped that this study will accelerate the acquisition of evidence about the effectiveness and safety of proposed new treatments, ensure patients with COVID-19 receive the optimal treatment for their condition based on the best current evidence at the time they are being treated, and ensure rapid implementation of new treatments

Patients with severe tricuspid valve regurgitation (TVR) not amenable to repair have conventionally undergone replacement with either a mechanical or bioprosthetic valve. These prostheses carry issues regarding anticoagulation management, and risks of thrombotic complications and structural valve deterioration. CardioCel® is bovine pericardium that is subjected to an anticalcification tissue engineering process (ADAPT TEP®) and reduces cytotoxicity by removing lipids, cells and cell remnants, nucleic acids and a-Gal (galactosyl) epitopes. Studies have suggested minimal to no evidence of calcification at 24 mths and resistance to infection. We aim to evaluate the safety and effectiveness of a cylinder reconstruction of the TV with CardioCel® in patients with isolated severe TV requiring surgical intervention who would have otherwise required TVR with a prosthetic valve. We will determine whether reconstruction of the TV with CardioCel® bovine pericardial sheet is comparable with traditional treatment in the early period after surgery and to assess heart function up to 2 years’ post-surgery. The potential outcome will be increasing the number of patients with severe TVR treated surgically to prevent deterioration of heart function.

The aim of this project was to review the efficacy of a form of psychotherapy called emotion-focused therapy (EFT) for binge-eating disorder (BED) among people 18 years and over. Participants initially completed a series of questionnaires focusing on binge eating frequency, binge eating psychopathology, depression and anxiety, and were then randomly allocated to either a treatment condition or a 3-month waitlist control group. Participants allocated to the treatment condition then attended 12 one-hour weekly session of EFT in which a therapist helped them to identify, understand and better cope with the emotions. Participants assigned to the waitlist control group did not receive psychotherapy during the 3-month wait but received treatment after this time. Participants completed a series of questionnaires focusing on binge eating frequency, binge eating psychopathology, depression and anxiety during and after treatment.

To determine if an online cognitive-behaviour therapy intervention for perfectionism is effective in improving the variables of perfectionism, depression, anxiety, stress, body image inflexibility and self-compassion compared to those who are in a waitlist control group.