ANZCTR search results

Type 1 Diabetes (T1D) is a chronic lifelong illness that requires a complex treatment regime. T1D is a condition that is often difficult for parents to manage and can cause significant stress in parents who have trouble dealing with their child’s condition. Parental stress is compounded as the child transitions to adolescence. An Acceptance and Commitment Therapy (ACT) intervention has been developed that may have the potential in reducing parental stress in parents of adolescents with T1D. The content of the workshop sessions will focus on the six core processes of Acceptance and Commitment Therapy (ACT): cognitive defusion, acceptance, self as context (self-compassion), contact with the present moment, values, and committed action. The aim of this study is to assess feasibility, acceptability and efficacy of Acceptance and Commitment Therapy (ACT) in managing the parental stress in parents of adolescents with T1D..

This is a first-in-human, single-centre, randomised, double blind, three-part multiple dose study to assess the safety and tolerability of OXT-328 and how this drug acts in the body in patients with chemotherapy induced peripheral neuropathy (CIPN). Who is it for? You may be eligible for this study if you are over 18 years of age and have moderate-to-severe CIPN. Study details: All patients with CIPN who choose to enrol in this study will be assigned by chance to receive multiple doses of OXT-328 or placebo. All participants will have their vital signs checked (heart rate, blood pressure, temperature, etc), and will provide blood and urine samples for testing. The data generated in this study will inform the design of future clinical studies and to select the dose(s) for future studies in patients with CIPN.

The primary aim of this research is to develop and examine the acceptability, feasibility and effectiveness of a malnutrition screening tool encompassing physiological, psychosocial, emotional, financial, and cultural determinants of malnutrition for patients with ALD (with or without ascites).

We want to find out how many women who test positive for Chlamydia Trachomatis infection in the urogenital region, are also infected in anal canal (back passage) . This study focuses on women who have no symptoms of infection and have had no anal sexual contact in the past six months. This is because, symptoms of chlamydia often do not show up in women. Also, anal canal chlamydia can be present when the vagina or urethra are infected, even when a woman has not participated in any anal sexual contact, and at this time we do not know how many women are cross infected in this way. This research help us understand how much anal chlamydia may be present in women infected with urogenital chlamydia but have no symptoms and no history of anal sexual contact. This is important as the medications used to treat the CT in the two different anatomical regions is different. ie the treatment for urogenital CT is not as effective as the optimal treatment for ano rectal CT. The research will help us to make any necessary policy changes to improve chlamydia detection and treatment, because if women with no symptoms are not tested correctly, this can result in several unpleasant health problems, with spread of infection to sexual partners and any unborn children the woman may carry. The study hypothesis is that In a North Queensland population of women with urogenital CT who are asymptomatic and report no previous anal sexual contact, 50% will test positive for concurrent anorectal CT (based on an estimate from data from a previous international study [Van Liere et al.,2014]).

Type 1 diabetes is a lifelong autoimmune condition characterised by high blood glucose levels. Children with early stage type 1 diabetes (defined as two or more (multiple) islet antibodies, Stage 1-2 type 1 diabetes) or at-risk of the condition (defined as a single antibody, pre-type 1 diabetes) require ongoing clinical monitoring for disease progression and to avoid life-threatening complications arising from late recognition of symptom onset and insulin requirement (i.e. Stage 3 type 1 diabetes). This study is a follow-on from The Type 1 Diabetes National Screening Pilot: Feasibility and Acceptability Study. It aims to include up to 36 children with type 1 diabetes antibodies, detected via screening, to evaluate the feasibility and acceptability of the international clinical guidelines for ongoing monitoring of children with early stage- or pre- type 1 diabetes.

This study aims to evaluate the safety, biodistribution and pharmacokinetics of 89Zr-hu/mo-10D7 to detect known tumour deposits in patients with advanced epithelial Ovarian Cancer. Who is it for? You may be eligible for this study if you are an adult with recurrent, histologically proven advanced ovarian cancer with a macroscopically visible tumour on diagnostic imaging. Study Details All participants who meet the eligibility criteria in this study will receive a single dose of 89Zr-hu/mo-10D7 as an intravenous infusion over 30 minutes to delivery maximum dose of 4.5 mg protein and 37 MBq radiation. During and after completion of the treatment participants will be assessed for safety, biodistribution and pharmacokinetics of 89Zr-hu/mo-10D7 via vital signs, blood tests, ECG, urinalysis and PET/CT scan. It is hoped that this research project will demonstrate hu/mo-10D7 targets advanced ovarian cancer metastases in humans and therefore prove its potential utility as a theranostic in ovarian cancer.

Primary sclerosing cholangitis (PSC) is a rare and chronic liver disease with no current effective medical treatment options. Patients with PSC are at high risk of bile duct cancer, recurrent sepsis, and many progress to liver transplantation within 10 years. Patients with PSC have an abnormal gut microbiota and current evidence suggests that manipulation of the gut microbiota holds promise as a therapeutic strategy in PSC. The proposed study is investigating whether faecal microbiota transplantation (FMT) from healthy donors, delivered via lyophylised (freeze-dried) capsules, is safe for patients with PSC. The study will also seek signals for efficacy in terms of improving liver function tests and liver duct changes visible on imaging. Participants who choose to enrol in the sub-study will undergo endoscopic-ultrasound guided portal vein sampling at the time of their baseline and week 24 colonoscopies. The sub-study aims to identify the composition and function of the microbiota of the portal venous system and their products, and to explore how this is altered by FMT. This may reveal important pathogenic links between the gut and the liver in PSC, which can be used to develop future therapies.

This study will evaluate the accuracy of an experimental CGM measuring glucose continuously in the immediate vicinity of subcutaneous insulin delivery in people with type 1 diabetes (T1D) on insulin pump therapy. Glucose sensory accuracy will be measured over a 7 days period, along with device survival and tolerability over the same period. Accuracy of the device will be tested in both a free living state, as well as over three seperate mixed meal challenges in order to test the device accuracy over a range of glucose levels.

Obstructive sleep apnoea (OSA) has serious negative impacts to the physical health, mental health, and cognitive function and development of children. Unfortunately, OSA is quite common and is reported to occur between 1-6% of children. However, currently, the gold standard for OSA assessment (a sleep study or polysomnography (PSG)) is expensive and difficult to access. The limited access to PSG testing leads to unnecessary risk for these children, as it often delays in treatment, and/or results in an incomplete assessment prior to surgeries like adenotonsillectomy. However, a novel postage delivered and home conducted kit may be able to reduce these issues. The Paediatric OSA Screening Triple Test (POSTT) is TGA approved and includes an overnight oximetry device, a validated sleep questionnaire, and video tonsil assessment tool. This proposed research will compare the novel POSTT kit to PSG and determine the diagnostic accuracy, real-world feasibility, and patient satisfaction and preference. We hypothesise that the POSTT kit will demonstrate to be as accurate and more feasible than PSG. If the hypothesise is correct, the novel kit will allow for an increase in access to care, especially for regional and rural patients.

Congenital diaphragmatic hernia (CDH) is a condition requiring immediate medical and multidisciplinary management, including physiotherapy. Positioning is a commonly used physiotherapy technique supported by the literature. However, the extent of its improvement on the respiratory system is unknown due to the limitations of the measuring equipment. Current measuring tools lack the ability to detect regional changes in the lungs. Electrical impedance tomography (EIT) has shown to be safe and effective in other areas of the healthcare system but has not been used for infants with CDH. This study will use EIT to assess the effectiveness of positioning in infants with CDH.