ANZCTR search results

This study will investigate cyclosporin in AA. This randomised, double-blind, parallel group, study will enrol a maximum of 38 subjects. The study will be conducted at Sinclair Dermatology. Subjects who have moderate to severe AA (at least 50% hair loss of the scalp without evidence of hair regrowth within the previous 6 months; current episode of fixed hair loss up to 7 years) present at the screening and baseline visits will be included in the study. Subjects will be randomised to cyclosporin or matching placebo in a 1:1 ratio. Investigators and subjects will be blinded as to treatment group. Subjects will be screened within the 35 days prior to the first dose of study drug to confirm that they meet the subject selection criteria for the study. The 12-week treatment period is followed by a 4-week follow up period after the last dose of investigational product. Non-responders will be eligible to participate in the extension phase of this clinical trial, investigating open-label tofacitinib.

Research aims: The aims of this trial is to assess the efficacy and rationale for routine topical antibiotic (Ciprofloxacin) for the prevention of grommet obstruction and otorrhoea in grommet surgery (myringotomy and ventilation tube placement) Hypothesis: That a single intraoperative dose of topical ciprofloxacin is as effective as a 5-day postoperative course for prophylaxis of two post-operative complications of paediatric grommet surgery when compared against no prophylaxis. That factors such as age, indication for surgery, number of previous grommets and intraoperative middle ear status are correlated with developing post-operative complications. That there is a significant patient reported quality of life benefit in prophylaxis compared to no prophylaxis. Participants: 360 paediatric patients (17 and under), who are undergoing bilateral myringotomy and ventilation tube placement, with a diagnosis of otitis media with effusion for at least 3 months or recurrent acute otitis media. Methods: 360 participants will be randomised to three groups. (1) Control group, receiving no intervention. (2) Single dose group, receiving one intraoperative dose of topical ciprofloxacin and no post­operative doses. (3) Multi dose group, receiving one intraoperative dose of ciprofloxacin and a 5­day post­operative course of topical ciprofloxacin (2 doses daily) Measured outcomes: (1) Incidence of ventilation tube obstruction at 6 weeks diagnosed by otoscopy and tympanometry.    (2) Incidence of ventilation tube otorrhoea at 2 weeks and 6 weeks by otoscopy. (3) Difference in validated disease specific QOL(OMO­22) at date of surgery and 6 weeks.  (4) Difference in audiometry pre­op and 6 weeks post­op.

This is a pilot study looking at the treatment of obstructive sleep apnoea (OSA) in patients with atrial fibrillation (AF), using a mandibular advancement splint (MAS). MAS is an alternative treatment to CPAP (continuous positive airway pressure) therapy, which adheres to the top and bottom dental arches and brings the lower jaw forward, thus preventing upper airway collapse during sleep. There is evidence suggesting that treatment of OSA improves outcomes for patients suffering from AF. This may be particularly true for those patients who have had treatments for their AF such as Cardioversion or Pulmonary Vein isolation. There are no randomised control trials looking at MAS treatment for OSA in AF patients. This pilot study will collect data on patient acceptance, efficacy and compliance of MAS treatment in this patient group. Secondary outcomes include AF recurrence rates, changes in blood pressure, heart rate variability and quality of life questionnaires. Data from this important pilot study will inform a future randomised control trial.

This is a healthy volunteer study to evaluate the safety, tolerability, and pharmacokinetics of a new drug called RT234.

This study aims to determine if patients with cardiac failure and pacemakers are being adequately assessed prior to consideration of listing for cardiac transplant. We hypothesise that by using a treadmill instead of a stationary bike as their functional assessment (cardiopulmonary exercise test) we will generate a higher degree of cardiac function and appropriately delay their transplant listing.

This preliminary survey will determine the baseline characteristics and preferences for prehabilitation in patients schedule for colorectal cancer resection. Who is it for? You may be eligible to join this study if you are aged 18 years or above, have been diagnosed with colorectal cancer and scheduled for surgical resection. Study details “Surgical prehabilitation” is the process of making an individual as fit as they can be, before an operation so that they can better tolerate the stress of surgery. Surgical prehabilitation includes exercise, improving nutritional status and psychological counselling with an intention to increase your strength before surgery. Studies have shown that increasing fitness can reduce complications following bowel surgery. We are looking to design a prehabilitation programme for cancer patients at the Prince Charles Hospital. To do that, we would like to know the health condition and fitness levels of the patients. We also want to know your preferences for such a programme. We believe that if we have this information, at a later date, we could design a programme that could be easily followed by the future patients. This is only a preliminary survey

This study's purpose is to facilitate and expedite the clinical testing of SEVI-D in a population with advanced cancer that are androgen receptor (AR) positive. Who is it for? You may be eligible for this study if you have a solid tumour with clinical/radiological progression on or following last anticancer therapy. There study has a focus on, but not exclusive to, rare or neglected cancers. Study details All participants will be screened to confirm if their solid tumour is AR positive by the study team. If eligible, participants will receive the medications of Serivteronel and Dexamethasone (also known as SEVI-D) by oral tablets continuously per cycle (4 weeks). Participants will be asked to have blood tests, scans, complete questionnaire and regularly meet with the study doctor and team. It is hoped this research will demonstrate this treatment could be beneficial for the treatment of cancers that are known to be human androgen receptor positive.

The aim of this study is to test the safety and effectiveness of prostate specific membrane antigen (PSMA) labelled with a radioactive substance called Lutetium-177 (177Lu) in progressive prostate cancer patients. Who is it for? You may be eligible to join this study if you are aged 18 years or over and have a PSMA positive, hormone refractory and progressive prostate cancer. Study details Participants will receive up to six 42-day cycles, with each cycle requiring a single intravenous injection of a radioactive substance called therapeutic 177 Lu-PSMA combined with NOX66. NOX66 is used to make cancer cells more sensitive to radiation treatment and is continued to be given the following 9 days after injection. The exact number of treatment cycles administered and dose given will be determined by the treating doctor. Participants will then be followed for one year after completion of study to assess safety and effectiveness of the intervention. Study rationale Using PSMA labelled molecules enables targeted delivery of high doses radiation to sites of prostate cancer. This treatment is called radionuclide therapy and it aims to minimise radiation of most normal tissue sites. Study Declarations This is a new type of treatment and long-term response and toxicity data are not yet available. The drugs used in this study are not approved by the Therapeutic Goods Administration (TGA) and considered an experimental treatment. This research has been initiated by the study doctor, A/Prof Louise Emmett, and is sponsored by St Vincent’s Hospital Sydney with funding provided by the St Vincent’s Prostate Cancer Centre and Noxopharm Ltd. This will allow you to have the LuPSMA / NOX66 treatment free of charge and for the conduct of the research.

The purpose of this study is to test two different implementation approaches (theory based and non-theory based) in achieving behaviour change amongst healthcare professionals to improve identification of Lynch syndrome amongst colorectal cancer patients. Who is it for? You may be eligible for this study if you are a healthcare professional involved in the Lynch syndrome referral pathway. Although we will be assessing the proportion of colorectal cancer patients appropriately referred for Lynch syndrome genetic testing (based on high-risk LS tumour screening results, e.g. mismatch repair deificiency, or microsatellite instability), we will be targeting the behaviours of health professionals in this study to improve referral practices. Study details Participants will take part in one of two arms (theory based or non-theory based) depending on the hospital in which they work. Participants will be asked to complete questionnaires and will be involved in a series of meetings and focus-groups to map the referral pathway, identify target behaviours for change, identify barriers to behaviour change and develop intervention strategies to address those barriers. Clinical and referral data will be collected before and after the study period to assess for changes in the proportion of patients appropriately referred for Lynch syndrome genetic testing. It is hoped that this research will increase the number of colorectal cancer patients with a high risk of Lynch syndrome who are appropriately referred for genetic counselling and testing.

The primary purpose of this study is to assess the effectiveness of a mobility device, commonly used for rehabilitation in America but not in Australia, for use by Australian adults with declining mobility living in aged care. We hypothesise that this mobility device will have a positive impact on the physical wellbeing of residents living in aged care, relative to mobility training alone.