ANZCTR search results

The study aims to find out if giving local anaesthetic (a medication that numbs an area of the body) into the bloodstream and via small plastic tube placed during surgery into the abdomen will improve part of the immune system in patients undergoing surgery for colorectal cancer. Who is it for? You may be eligible to join this study if you aged 18 years or more and are scheduled to undergo a keyhole operation (laparoscopic surgery) for colorectal cancer to remove a section of the bowel (also known as colon). Study details Participants in this study will be randomly allocated (by chance) into one of two groups. Participants in one group will receive a local anaesthetic drug called Lignocaine infused directly into the bloodstream and also into the abdomen using a small plastic tube placed during surgery. Lignocaine is very commonly used to numb areas of skin or muscle before or during an operation. Importantly it has also been shown to help the natural killer cells (NKC) to destroy cancer cells. NKCs are a special type of white blood cell which recognises and destroys cancer cells. Participants in the other group will instead be given a placebo (salty water). Participants will not know which group they are in. All participants will be monitored for up to 30 days post-surgery in order to evaluate safety and also to see if the natural killer cells in the blood work better after lignocaine is used.

Study Aims This study aims to assess the impact of a telehealth-delivered cognitive and exercise training (CET) program versus lifestyle guidance on cognition in breast cancer patients. Who is it for? You may be eligible to participate in this study if you are aged 21 years or older, have been diagnosed with Stage I-III breast cancer and are scheduled to receive chemotherapy treatment. Study details Participants will be randomly assigned (by chance) to receive either the cognitive & exercise training (CET) program or lifestyle guidance program. Those in the CET group will be asked to undertake cognitive and exercise training four times per week (4 hours in total). The lifestyle guidance group will be provided with evidence-based recommendations regarding cognitive and exercise training. All participants will undergo a series of diagnostic and clinical tests, including blood tests, fitness and cognitive tests, sleep tests and questionnaires. Potential study outcomes It is hoped this research will inform the treatment of breast cancer patients presenting with detrimental cognitive changes as a result of chemotherapy, and this research may lead to better quality of life for patients.

This controlled trial aims to determine the feasibility of virtual reality as a non-pharmacological approach to improve mood states within Residential Aged Care. Specifically, we aim to determine the effects of virtual reality on: • Mood as measured through the use of observer and participant ratings of emotional response, apathy, and group engagement • Agitation, anxiety, and depression levels • Psychotropic prescribing and the administration of pro re nata (PRN) medications We hypothesize that group based VR sessions will increase resident engagement and social interactions, reduce agitation, anxiety and apathy, and improve mental wellbeing. Based on the finding of the pilot study we have conducted we anticipate results that have the potential to change the landscape of leisure and lifestyle activities conducted in RAC homes, and to supplement our current knowledge of non-pharmacological approaches for RAC resident mental wellbeing.

In this randomised, double-blind, placebo-controlled study, 160 adults who are currently taking an antidepressant medication but continue to suffer from depressive symptoms (mild-to-moderate severity) will be randomly assigned to receive tablets containing either a saffron extract (28mg a day) or placebo for 8 weeks. Participants recruited for this study will be on a stable medication dose for at least 8-weeks and will have no plan to change the dosage or medication type during the study. We will assess change in depressive symptoms via a validated clinician-rated instrument and a self-report measure (to be completed every 4 weeks). We will also assess whether saffron is able to reduce some of the side effects associated with antidepressant drug use (in 2 studies it has previously shown to reduce sexually-related side effects).

Currently, we use a stethoscope to listen to the bowel sounds during examination of the newborn baby. We have now a simple sensor the size of a 20 cent coin, which when placed on the surface of your baby’s abdomen, can pick up bowel sounds without disturbing the baby. Purpose of this study We want to check the usefulness of the new method in picking up bowel sounds in newborn term babies and term sick babies.. What does this study involve? We would like your help with making a 10 minutes recording of bowel sounds in well babies – for 5 minutes before and 5 minutes after a feed in healthy well term and near term babies who are in the NICU. Having recordings of normal bowel sounds may allow us to use the bowel sounds sensor to help babies who are unwell. The bowel sounds sensor may allow us to detect early bowel problems in sick babies and also help us to decide the right time to start feeding in sick babies who are recovering.

Cold snare polypectomy (CSP) is a relatively recent development but has rapidly gained international acceptance as an effective and safe polypectomy technique. It is now the standard of care internationally for resection of small polyps (i.e. sized <10mm), and has become the standard of care for resection of intermediate-sized polyps (sized 10-19mm) at leading academic endoscopy centres. It has not yet been adopted at most other non-academic endoscopy centres for polyps in this intermediate size range. It is now known that “cold snares” (that don’t use electrocautery) are effective for polyp resection. Cold snares use a thin, stiff, monofilament wire to cut out the polyp, without the need for electrocautery. This is a big advance, as it is the electrocautery that is the main cause of post-polypectomy complications such as bowel perforation, serositis, post-polypectomy syndrome, post-procedure pain and post-polypectomy bleeding. Therefore, polypectomy using cold snare has the potential to significantly reduce the risk of complications following colonoscopy. While the evidence for the efficacy of cold snare polypectomy for resection of small polyps is established, rigorous data for intermediate-sized polyps is still limited. In our own practices, and in the setting of small, published retrospective studies, we have observed cold snare polypectomy to be very effective for intermediate-sized polyps as well. However, to establish robust evidence, a well-designed, prospective, multicentre, observational study is required. The primary aim of this prospective observational multicentre study is to measure the incomplete resection rate of intermediate-sized sessile polyps as determined by the histological examination of polypectomy site biopsies. The major secondary aims include to measure residual polyp rate during first surveillance colonoscopy, measurement of immediate and delayed complications. All patients undergoing elective colonoscopy at all participating academic centres will be screened to assess their eligibility into the study based on exclusion and inclusion criteria. During the colonoscopy procedure if a medium sized polyp (10-19 mm) is detected and excised using cold snare polypectomy technique will become the part of the study. Study data Study data from multiple sites will be entered into an encrypted, password protected web-based database. The study is a prospective audit of all new cases of CSP for one year with an additional follow up to review endoscopic findings during the first routine surveillance colonoscopy. At least fifteen leading endoscopy centres around Australia are expected to contribute to the study. 350 polypectomy cases are expected to be recruited during the study during the first year, another two to three years of follow up is required to obtain results of the surveillance colonoscopies.

In a previous small single centre study of twenty four children with new diagnosis CD, we confirmed symptoms based score alone (PCDAI) was unreliable, blood test (CRP) had moderate utility and stool biomarkers (FC) had the best individual utility in predicting endoscopic mucosal healing. We also demonstrated that combination of PCDAI less than10, CRP less than 5mg/dl and FC less than 500 µgram/gm has greater accuracy identifying mucosal healing (SES-CD equal to 0-2) following standard EEN or Steroid induction therapy with specificity of 85% and positive like hood ratio 5.3. The reliability of this composite score (PCDAI less than 10, CRP less than 5mg/dl and FC less than 500 µgram/gm) in this small pilot study needs further validation in a larger prospective multicentre cohort study. To overcome limitations of this pilot study, we also want to extend this study to include; children with established CD experiencing clinical relapse, those in clinical remission with raised surrogate biomarkers (CRP more than 5mg/L and/or FC more than 250 µgram /gm of stool) and confirming mucosal healing in those with normal surrogate markers (CRP less than 5mg/L and FC less than 250 µgram /gm of stool and no symptoms. Our hypothesis is that establishing reliability of this composite index in predicting endoscopic healing in this mixed sample population will be useful both as a discriminative tool (for distinguishing active (SES-CD equal to 3) vs. inactive inflammation (SES-CD equal to 0-2) and evaluative tool (for defining treatment success).

Australian men are recognised as hard-to-reach for the promotion of healthy lifestyles and disease prevention. Evidence suggests, however, that when gender-specific concerns and approaches frame program design and delivery, men tend to engage with weight management, physical activity (PA) and health promotion initiatives. Active Breed is a 12-week, gender-tailored men's health program targeting weight loss, physical activity, nutrition, mental health, and violence prevention. The program will be delivered through the Canterbury-Bankstown Bulldogs Rugby League club and will include weekly education and physical activity sessions held at the club's home stadium.

The purpose of this research is to understand the molecular mechanisms of eye disease and to correlate this with variations in the speed of deterioration and disease manifestation between individuals. Part I of this project is to monitor the retina once every 6 months through a series of detailed tests which allows us to determine if the disease has progressed over a 5 year period. Part II of this project is to collect blood, urine saliva, skin and or eye tissues to study RNA, DNA and biomarkers in the blood and to create induced pluripotent stem cells from somatic cells. Combining Part I and Part II of the study will facilitate discovery of new methods or biomarkers to better predict retinal disease progression and future treatment response. Part I: High resolution retinal imaging can provide information on microscopic changes within the living retina. Fundus autofluorescence, optical coherence tomography and adaptive optics imaging are new techniques that may enhance our ability to detect very subtle changes within the retina in patients with slowly progressive retinal degeneration. The aim of part I of the research is to find out if new methods of analysis can detect changes in these serial retinal images over a period of years which an experienced image grader is unable to identify or measure. Part II: Biomarkers in the blood will be analysed. This includes anti-retinal antibodies, RNA and DNA. Induced pluripotent stem (iPS) cells are stem cells generated in the laboratory, generally from skin cells that have been reprogrammed and induced to become pluripotent that is, they have the ability to form any cell type of the body. This characteristic makes iPS cells similar to embryonic stem cells with the potential to form any organ in the body. The aim of part II of the research is to generate iPSC from skin cells of people with retinal disease. This will allow the development of stem cell lines that will then be studied to further understand the mechanisms of disease. This can be correlated with specific genetic variants to determine how genetic mutations cause disease and vision impairment. Importantly, new knowledge into the molecular mechanisms of disease can help to identify potential targets for therapies for people with eye disease. This research is based at the Lions Eye Institute incorporating the Centre for Ophthalmology & Visual Science, The University of Western Australia.

Kidney transplantation is a definitive treatment for patients with end stage kidney disease, which extend the patient life expectancy and improve quality of life. During the surgery of kidney transplantation, placement of a ureteric stent at ureter-bladder anastomosis has been confirmed beneficial from systematic literature review and meta-analysis as it reduces the urological complications of urine leakage and ureteric stenosis. On the other hand, placement of a ureteric stent is associated with stent-related complications such as urinary tract infection, BK virus infection, stent irritation symptoms, haemoturia, stent encrustation and rarely “forgotten stent”. In addition, it will require a procedure of cystoscopy under hospital admission to remove the ureteric stent under local anaesthesia or general anaesthesia. It is unknown how long period should a ureteric stent be best kept in situ before it is removed. Most transplant units have schedule to remove the ureteric stent ranging from 7 days to 12 weeks. Therefore, the aims of this study are to investigate the outcomes of early removal of a ureteric stent simultaneously with removal of indwelling urethral catheter (IDC). The surgical procedure will be slightly modified, in which a 4/0 suture string is used for connection of the stent with the tip of urethral catheter. As such, the stent will be removed by the string following removal of the urethral catheter.