ANZCTR search results

The purpose of this study is to compare the effects of two internet-delivered interventions on mental health. Who is it for? Eligible participants include adult cancer survivors who have finished their primary treatment for cancer within the last two years. Study details Participants will be randomly selected to take part in one of two interventions: 1. The CanCope Mind intervention, which focuses on helping individuals understand, recognise and respond to uncomfortable emotions, or 2. The CanCope Lifestyle intervention, which focuses on health eating, physical activity, relaxation, and sleep. Both interventions are delivered online over an 8-week period. All participants will need to complete questionnaires during the 8-week period and at 3-months after they have completed the intervention. The findings from this study will inform how to best support the mental health needs of individuals affected by cancer. If effective, the CanCope programs will be one of the few online and easily accessible interventions developed for cancer survivors.

This study is a randomised, crossover, double-blinded, single-dose experimental trial investigating the effects of purified, oral cannabidiol (CBD) on exercise physiology and bioenergetics in healthy individuals. Participants will complete two experimental sessions involving either (1) CBD (300mg) or (2) Placebo (0mg). Trials will be conducted at the Charles Perkins Centre Research. We hypothesise CBD will decrease submaximal oxygen consumption during moderate intensity exercise (~75% HRmax).

Although 5-10% of women with endometriosis will have bowel involvement, currently it is very difficult to predict this group preoperatively. This group of women require both gynaecological and colorectal input at surgery. Preoperative imaging is being increasingly utilised to predict the level of complexity of laparoscopic surgery for endometriosis. It has the potential to facilitate the triage of women with suspected bowel deep endometriosis (DE) to the most appropriate surgical expertise required for laparoscopic intervention for endometriosis. Transvaginal ultrasound (TVUS) (Guerriero S, et al. UOG, 2016) and magnetic resonance imaging (MRI) (Medeiros, et al. Arch Gyn Obs, 2015) have been shown to accurately diagnose the presence of rectosigmoid DE. Recently, positron emission tomography-computed tomography (PET-CT) with 16a-[18F]fluoro-17ß-estradiol ([18F]FES) has had promising results when compared with MRI. The study would be a prospective observational pilot study on women who present with suspected bowel DE diagnosed on TVUS and a plan for laparoscopic endometriosis surgery. Women would undergo a detailed history and clinical examination including a specialized TVUS, MRI and PET-CT with [18F]FES in a tertiary referral unit prior to laparoscopy.

This study seeks to evaluate the safety and the effectiveness of an experimental type of spinal cord stimulator. The device is not yet approved for use in Australia for the treatment of lower back pain with or without leg pain. The experimental device is used for 15 days and is then removed. The experimental stimulator delivers a different wavelength than other traditional spinal cord stimulators and it may help to alleviate pain.

This research aims to determine the feasibility and acceptability of inspiratory muscle training in people with Parkinson’s disease who currently attend an exercise clinic. We hope to see if this type of training is accepted by people in this population, if this training modality if feasible for this population, and feasible via telehealth if administered this way.

This study is looking to find an optimal insulin-dosing strategy that effectively and safely controls blood glucose levels after meals in people with T1D on closed loop insulin pump therapy. The study involves 8 study days over the course of two weeks while the participant is using the currently available closed loop insulin pump system. The study will be split over two weeks with one week using the closed loop function and one week without. During this time the participant will test different insulin dosing strategies over two different meal types (4 meals will be high in carbohydrate, 4 meals will be high in fat and protein). Blood glucose will be measure through the cgm linked to the pump and this will be used to measure blood glucose levels and time in target after each meal. This will be used to determine the most effective insulin dosing strategy.

This study is a feasibility study looking at personalised medicine for asthma. A planned full randomised controlled trial would test whether tailoring a patients treatment according to an algorithm based on their asthma symptoms, level of airway inflammation and airway narrowing gives better results than usual care. Before we can run that full RCT we need to test 5 specific feasibility questions around recruitment, acceptability, and the proportion of participants with co-morbidities which may change how we run it. This open-label single group cohort feasibility study will provide the answers to these five specific questions which may change how we run the full RCT: 1)How quickly can we recruit? 2)Do participants find the intervention acceptable? 3)In theory would participants be willing to take part in a randomised controlled trial testing this approach? 4)What proportion of patients still have not-well controlled asthma at the end of the study, or have had an exacerbation during the study? 5)How common are the additional conditions (e.g. sinus disease) that are looked for at the final visit? Fifty participants will be recruited, 25 in New Zealand and 25 in Australia. Each participant will attend for 3 visits over 10 weeks and will have their medications adjusted according to the treatment algorithm specified in the protocol. All participants will receive inhaled steroid and long-acting bronchodilator medications in line with national and international guidelines. The difference is that the dose of inhaled steroid and whether or not participants are prescribed oral steroids (prednisone) will be adjusted according to the protocol algorithm rather than individual clinician's judgement.

Quinidine is the only drug shown to reduce the risk of dangerous irregular heart rhythms in Brugada Syndrome. While studies have shown invasive electrophysiology studies can be useful in assessing response to quinidine in Brugada Syndrome, currently, there is no definitive way to monitor drug effect in an individual. The QUIET BrS Study will investigate the effect of quinidine on a variety of clinical parameters in patients with Brugada syndrome. We seek to identify non-invasive markers of quinidine effect in patients with Brugada Syndrome which could be used to develop a non-invasive strategy for monitoring medical therapy in these patients and reduce the need for invasive procedures.

Ulcerative colitis (UC) is a chronic inflammatory condition affecting the colon and is associated with significant morbidity and impairment to quality of life. Adalimumab is approved and marketed in Australia, US and EU for treatment of UC. Its efficacy is suboptimal when given subcutaneously. This Phase 1 study will assess the PK/PD parameters following dosing with adalimumab administered rectally as an enema in subjects with active UC. Rectal administration will bring the drug into closer proximity with the inflamed tissues at much higher local concentrations compared to subcutaneous administration. As the Sponsor is developing an ingestible drug/device capsule intended to deliver the drug payload (adalimumab) into the cecum, the rectal administration via an enema was chosen as an initial step to assess the absorption of adalimumab across the mucosal/epithelial interface of the cecum. Data obtained from this study will assist in determining the starting dose/dose regimen for the Progenity PGN 001 program by providing further understanding of absorption, bioavailability, and the early safety data of adalimumab following local administration in subjects with UC in local tissues as well as systemically.

Doctors currently examine the human gastrointestinal tract using a device called an endoscope, which contains a camera that enables the doctor to view and treat diseases from within the gastrointestinal tract. Most endoscopic procedures are done under sedation, what means that people are put asleep during such procedures by an Anaesthetist. During the examination, it is costumery that the patients' breathing capabilities become mildly impaired. For this reason, the Anaesthetists utilise supplementary oxygen to avoid the oxygen levels in your blood getting too low. Although we know that using some supplementary oxygen is better than using none, it is still under debate what is the ideal amount (or flow) of oxygen that should be used to avoid the loss of oxygenation. The purpose of this study is to determine whether two devices that deliver two different flows of oxygen (standard nasal cannula - 2 L/min or high-flow nasal cannula - 60L/min) are similar or different in preventing the loss of oxygenation while under sedation for long endoscopic procedures.