ANZCTR search results

Fatigue is experienced by more than 50% of stroke survivors, and leads to reduced independence and quality of life. It persists even after other symptoms have resolved. In spite of its importance to stroke survivors, there are no proven means of minimizing this fatigue. We plan to conduct a novel randomised controlled trial (RCT) to establish whether a 10-week intervention that increases the frequency and duration of physical activity after stroke will reduce fatigue and improve quality of life. The intervention has 4 key elements: personalised physical activity plans, goal setting, daily feedback and peer support. Our aim is to increase habitual activity levels through long-term behaviour change; the intervention is not reliant on specialised equipment or services. Outcomes will be assessed before and after the intervention period. In addition to the primary outcomes of fatigue and quality of life, we will assess physical activity levels, sleep, fitness, muscle strength, depression and anxiety. Currently, there is uncertainty about whether to prescribe exercise or rest to stroke survivors with fatigue. Evidence that physical activity improves post-stroke fatigue has the potential to change practice, translating directly into clinical guidelines.

Colonoscopy is one of the most common medical procedures performed in Australia. Patients having colonoscopy take oral bowel preparation and fast before their procedure. During their procedure they receive sedative drugs. All these factors can cause low blood pressure during the procedure. In addition they can be associated with nausea, vomiting, headache, dizziness, drowsiness, thirst and low satisfaction with care after the procedure. We are testing whether a high volume (2o mL/kg) of a balanced salt solution given intravenously before the procedure will prevent low blood pressure and unwanted postoperative symptoms when compared with a low volume (2 mL/kg) of the same solution. We are testing this in adult patients presenting for elective colonoscopy at our hospital.

This study is a Phase I, randomized, double-blind, placebo-controlled PK study of nicotine levels over a 30 hour period in healthy Caucasian male volunteers, 12 per arm (blinded), who are smokers, using the Chrono Nicotine Replacement Therapy System. Study participation will involve: *Screening: 1 site visit (up to 14 days prior to Day 1) * Study Treatment: 30 hours in an in-patient facility * Follow-up: 1 site visit (within 7 to 10 days of discharge)

This clinical trial aims to explore the safety and tolerability of Atorvastatin Oro-buccal Spray Micelle. Who is it for? All participants who are aged 18 years or over with no allergic reactions to statins

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.