ANZCTR search results

This study aims to compare the efficacy of two different versions of Fear-less Triple P, a program for parents of anxiety-disordered children. The two versions differ in terms of intensity. The first version is the standard 6-session Fear-less program. The second version includes content from the 6-session Fear-less program but is delivered as a 6-hour workshop.

The purpose of this study is to determine whether or not treating patients with cisplatin and gemcitabine chemotherapy helps reduce the risk of cancer returning. Who is it for? ACTICCA-1 is a clinical research study for people who have a cancer of the biliary tract (cancer of the gall bladder or bile duct, also known as cholangiocarcinoma in medical terms) which has been removed in an operation. Study details These drugs are being tested as they have been shown to be the most effective chemotherapy combination in more advanced cases of biliary tract cancer, where the disease is inoperable or has spread to other areas of the body. This is an international investigator initiated study called ACTICCA-1, which is being led by the University Medical Centre Hamburg- Eppendorf in Germany and conducted in Australia by the Australasian Gastro-Intestinal Trials Group (AGITG) in collaboration with the National Health and Medical Research Centre Clinical Trials Centre (NHMRC CTC), University of Sydney. The study involves randomly allocating participants to receive either chemotherapy with cisplatin and gemcitabine or the current standard of care (capecitabine). The drugs used in this study are approved in Australia to treat various cancers, however they do not have a specific listing by the Australian Therapeutics Goods Administration (TGA) for biliary tract cancer It is hoped that the findings of this study will provide details on whether giving cisplatin and gemcitabine chemotherapy following surgery for cancer of the biliary tract is a safe and effective treatment to reduce the chance of disease progression and increase survival time and quality of life. Radiotherapy Sub-Study – Second Randomisation for R1 Patients at Participating Sites The purpose of the radiotherapy sub-study is to assess the role of adding radiation to chemotherapy in a subgroup of participants to see whether the addition of radiation can further reduce the risk of relapse. Only participants with R1 resections (cancer cells present microscopically at the resection margin) to will be asked to join the sub-study. Participants will be assigned into groups for a second time to either continue to complete their chemotherapy course or to receive chemoradiation (radiation therapy and capecitabine) for a period of 5 weeks, after the initial 18 weeks of chemotherapy (arms AR and BR, described below). Patients are followed up for 5 years maximum from randomisation.

Acute Respiratory Distress Syndrome (ARDS) is a severe form of lung damage that follows a variety of insults, most commonly infection. This is characterized by lung inflammation and flooding of airspaces within the lung by fluid leaking from the blood vessels. Patients with ARDS usually require life support from a breathing machine (ventilator). About 34% of patients suffering from ARDS die despite best care. At any given point about 6% of patients in all Australian ICUs are suffering from this disease. There is growing evidence to suggest that higher salt levels in the blood may have protective effect on lungs in ARDS. Higher salt concentrations in blood have been shown to reduce inflammatory damage to the lungs, less flooding of airspaces and improved function. However, these data are from isolated cell studies or experiments in non-human lungs. There is an urgent need to explore the beneficial effects of high salt concentration in blood in a controlled study in humans. As a first step towards investigating the beneficial effect of a high blood salt concentration, we will randomize 40 patients with ARDS to either receive usual care or usual care with additional treatment to increase the salt concentration in blood. Higher salt concentrations in blood will be achieved by administering fluids with higher salt content and will be maintained up to 7 days. Daily assessments of lung function and severity of illness will be performed along with close monitoring of any adverse effects of high salt concentrations.

The objective of this First-in-Human (FIH) evaluation is to assess the safety and effectiveness of the Cibiem Transvenous Ultrasound System (CTUS) for percutaneous unilateral carotid body ablation in subjects with difficult to control hypertension.

This research project aims to help 'close the gap' for Aboriginal and Torres Strait Islander mothers and babies by improving health services, in particular smoking cessation programs for pregnant women. Smoking in pregnancy can cause miscarriage, baby born too early (premature), low birth weight for baby (unhealthy baby), breathing problems and sickness for baby, and sudden infant death syndrome (SIDS). Smoking among pregnant Aboriginal and Torres Strait Islander women remains more than three times as common as among non-Indigenous pregnant women, yet there is little evidence of the best way to address this problem. As part of the Birthing in Our Community maternity care program, we will be implementing a novel smoking cessation program - “Stop Smoking in its Tracks”. The program involves intensive support to help women quit, free nicotine replacement therapy, rewards for confirmed abstinence and continues for six months post-partum. Support will also be offered to household members if they want to quit. This study will assess how effective the program is, what women think about it, and how easy it is to provide “Stop Smoking in its Tracks”. The study will involve collecting information on the care provided, whether women quit smoking and what other factors might be influencing quit attempts and successful quitting.

The project aims to compare the efficacy of cognitive behaviour therapy (CBT), with mindfulness-integrated cognitive behaviour therapy (MiCBT) on the reduction of stress for parents of children with Intellectual Disability (ID). We aim to evaluate which intervention is most effective, in terms of treatment effect size as well as acceptability for this population of individuals. We also aim to evaluate the overall service of these two therapies, for future implementation in treatment settings. In addition, we also aim to identify potential variables which may modulate the efficacy of the treatment, such as parental cognitions, child behaviour, and the quality of the interaction between parents and children. Identifying contributing variables may help us better understand the mechanisms involved in parental stress reduction, and provide avenues for further research.

At present there is no cure for food allergy. People with a food allergy need to avoid the food they are allergic to in order to stay safe. However we know that accidental exposure is common. Research shows that 50% of children with a peanut allergy are accidentally exposed to peanut within 2 years. Researchers have begun to look at the effectiveness of 'oral immunotherapy' as a treatment for food allergy. In oral immunotherapy, patients with food allergy are given small amounts of the food they are allergic to and tested for food allergy after a set amount of time. Results have been mixed. Studies suggest that oral immunotherapy can induce desensitization (short term ability to tolerate the food allergen while the patient continues on therapy) but has a limited ability to induce sustained unresponsiveness ( longer term ability to tolerate the food allergen after treatment is stopped for at least 2-4 weeks or longer). We conducted a RCT to evaluate a novel combination treatment approach involving administration of probiotic together with oral immunotherapy - Probiotic and Peanut Oral Immunotherapy (PPOIT). In our study we found that just over 80% of children who received PPOIT tolerated peanut after stopping treatment for more than 2 weeks compared with only 4% in the placebo group. PPOIT was highly effective at inducing sustained unresponsiveness - if 9 children were treated with PPOIT, 7 would benefit. PPOIT participants received a daily dose of probiotic together with peanut protein (peanut flour) for 18 months. The probiotic was taken as a fixed daily dose. The dose of peanut protein was commenced at very low levels then increased every 2 weeks over a period of 8 months to reach a maintenance dose of 2g peanut protein. This study (PPOIT-II) will build on our previous PPOIT study.

Understanding diurnal IOP variations over a 6 week period may provide clinically useful information to guide management decisions in patients with confirmed glaucoma who are commencing treatment or patients at risk of developing glaucoma. We hypothesize that extended IOP self-monitoring will provide refined insight of the patient’s response to treatment and diurnal IOP data that should enhance classification of the patients according to glaucoma progression risk. Such results may significantly alter glaucoma management and improve outcomes.

A proportion of individuals with schizophrenia (SZ) do not respond adequately to clozapine, with anything from 40-60% of individuals having residual symptoms at the completion of an adequate trial of clozapine. Agents that could work synergistically with clozapine to improve efficacy whilst not increasing the side effect burden are both desired and necessary to improve the lives of individuals with clozapine-resistant SZ, such as N-acetyl cysteine (NAC). Our group has extensive experience with NAC with pilot data support from a rigorous RCT exploring the efficacy of NAC in clozapine-resistant SZ. This project grant seeks funding to expand this work by conducting a multi-site randomised placebo-controlled trial of NAC in the treatment of clozapine-resistant schizophrenia, with 8, 24 and 52 week endpoints. We will target negative symptoms as our primary outcome measure, with quality of life and cognition as secondary outcomes. We will examine both peripheral and cortical glutathione concentrations. Additionally, we will measure a number of other biomarkers pertinent to the glutathione hypothesis. Such analyses will further our understanding the role of oxidative stress in SZ. The trial is a randomised controlled double-blinded superiority trial of two parallel patient groups. The study will be conducted across four Australian sites, namely Melbourne (St Vincent’s Mental Health Service), Sydney (Cumberland Hospital), Adelaide (Northern Adelaide Local Health Network), and Brisbane (Metro South Addiction and Mental Health Service). Forty-two patients will be recruited from each of the sites, with a total target of 168 patients aged 18 - 65 years meeting DSM-5 criteria for schizophrenia. Block randomisation will be used. This trial, if successful, will establish a cheap, safe and easy-to-use agent (NAC) as a ‘go to’ adjunct in patients only partly responsive to clozapine.

We have previously demonstrated that consuming a mixture of whey protein and guar gum (a dietary fibre) before a meal (as a “preload”) can slow stomach emptying and improve blood sugar control after the meal in people with type 2 diabetes. In the current study, we want to compare the effects of the whey protein and guar gum given either separately or in combination in people with type 2 diabetes. The current study is designed to evaluate the acute effects of whey protein and guar gum given in advance of the main meal either alone or in combination, on postprandial glycaemia (glucose levels after a meal), gastric emptying, glucose absorption, and the release of gut hormones and insulin in patients with type 2 diabetes.