ANZCTR search results

The primary purpose of this trial is to investigate the feasibility and efficacy of performing contrast enhanced spectral mammography (CESM) in comparison with the standard of care tests (which are breast tomosynthesis and ultrasound) for the detection of breast cancer in women with dense breast tissue. Who is it for? You may be eligible to participate in this study if you are aged 18 to 65, have dense breast tissue and have been recalled for further investigation of least one non-calcified finding on a screening mammogram. Study details: As part of standard care investigations, all participants enrolled in this trial will undergo tomosynthesis of the breast in which a possible abnormality has been found and an ultrasound scan of both breasts. The tomosynthesis study is a type of mammogram that is able to show the breast tissue slices, As part of this trial, a contrast enhanced spectral mammogram is being tested. This involves the injection of a dye into a vein, followed by two mammogram pictures of each breast taken 2-4 minutes later. The specialised equipment used for the CESM study is able to take mammograms at two different energy levels as well as performing the normal tomosynthesis study. This CESM study is taken at the same time as the tomosynthesis scan and the combined tomosynthesis and CESM study will take about 12 minutes from the start of the injection to completion of the pictures. During this study, the injection will be given first with the participant seated. Two to four minutes later the participant is asked to stand and mammograms of both breasts will be taken with the breasts gently compressed. The tomosynthesis mammograms are taken first, immediately followed by the contrast enhanced mammogram. The tomosynthesis and CESM scans are both taken during the same episode of breast compression ie each breast is only compressed once for each of the views that is taken. Having the CESM scan will mean the breast is compressed for approximately one extra minute longer per view than for a tomosythesis only scan. Researchers will compare the results of the CESM scans to the results from the tomosynthesis and ultrasound scans. Based on all results available, the physician will then make a decision as to whether any further tests, such as a needle biopsy are needed. The treating doctor will be asked to rate their level of confidence in the diagnosis made, and researchers will follow-up to assess whether performing the CESM scan was able to reduce the need for further tests such as needle biopsy and ultrasound. It is hoped that the findings from this trial will provide information on whether CESM may be a useful and feasible tool to aid in the diagnosis of breast cancer in women with dense breasts and help prevent unnecessary extra tests.

The overall aim of this study is to examine whether oxytocin has a mechanistic effects on pain perception, physical functioning, central sensitisation, and physiological and psychological arousal in individuals with musculoskeletal pain associated with chronic neck and shoulder pain. This study involves receiving a one-off administration of oxytocin, relative to placebo, to investigate the role of this peptide in pain experience. Oxytocin is a hormone that is produced naturally within the human body. Although it is traditionally known for its role in initiating childbirth and breastfeeding, oxytocin has also been shown to have pain- and anxiety-reducing effects. We expect that oxytocin will help you to modulate your responses to painful experiences.

One of the most serious complications of general anaesthesia in pregnant women is hypoxic brain injury and fetal and/or maternal death related to difficulty oxygenating a pregnant woman. This is due to inability of the anaesthetist to intubate the trachea and ventilate a pregnant woman because of the changed anatomy and physiology of pregnant women leading to the known problem of the difficult obstetric airway. The latest obstetric airway management guidelines by the Obstetric Anaesthetists’ Association (OAA) & Difficult Airway Society (DAS) discuss the importance of pre-oxygenation in managing pregnant women undergoing general anaesthesia as it increases oxygen reserve in the lungs during apnoea. The guidelines recommend that the end-tidal oxygen fraction (FetO2) of equal to or greater than 90%, indicating effective lung denitrogentation, should be achieved prior to induction of anaesthesia. The current way anaesthetists pre-oxygenate pregnant women undergoing general anaesthesia is to use a tight fitting face mask to deliver 100% inspired oxygen. The new guideline also states an alternative method. The guidelines states that nasal oxygenation, to facilitate bulk flow of oxygen to the alveoli could be considered as part of 1. Pre-oxygenation - A pre-oxygenation method and 2. Apnoeic oxygenation - A technique to increase apnoeic time. The guideline suggests that the anaesthetist should consider attaching nasal cannulae with 5 l.min-1 oxygen flow before starting pre-oxygenation, to maintain bulk flow of oxygen (O2) during intubation attempts, or attach nasal oxygenation after pre-oxygenation during the apnoeic period. There is also mention of humidified high flow nasal oxygenation however no data exists in pregnant women as to its safety or efficacy or acceptability by pregnant women. It is possible that a new pre-oxygenation technique, using high flow humidified nasal oxygen, may have an application in pregnant women however before this new pre-oxygenation technique is considered, it should be equivalent (at least) to the current available technique in terms of safety and efficacy i.e. be able to obtain FetO2 of at least 90% after three minutes of pre-oxygenation. Currently there are no studies reporting FetO2 values in pregnant women with high-flow humidified nasal oxygen delivery systems and no studies reporting the use of nasal high flow oxygen to increase apnoea times therefore it is unclear whether humidified high flow nasal oxygenation, is safe and beneficial in pregnant women. In this prospective study we aim to recruit two groups of women. The first group of women will be those who will electively undertake high flow humidified nasal oxygenation in order to examine this technique in the setting of pre-oxygenation (Pre-oxygenation group). The second group of women will be those who are undergoing general anaesthesia for caesarean section and will have high flow humidified nasal oxygenation after induction of anaesthesia.

Obesity and diabetes have become global epidemics. It is known that adequate physical activity and a healthy diet are among the key factors in weight control and management of type 2 diabetes. However, participation in regular exercise could be a challenge to some individuals with various capacities. There have been reports in the literature that hypoxia interventions, alone or combined with exercise, may have beneficial effects on weight control and blood glucose homeostasis in individuals with obesity and hyperglycaemia. With advancement of technology, hypoxia chambers and breathing devices (hypoxicators) have become available to provide air with various levels of oxygen. Whether hypoxia can be validated as an alternative or complementary intervention for obesity and diabetes requires further research. The aim of this research is to conduct a preliminary investigation on the effect of four weeks intermittent exposure to mild hypoxia (with the target blood oxygen saturation level at approximately 90%) on blood glucose homeostasis and insulin sensitivity in individuals with impaired fasting blood glucose. The participants’ responses (including blood oxygen saturation level, heart rate, and blood pressure) during the intervention sessions will be closely monitored, and their blood glucose, insulin and HbA1c levels, and glucose tolerance will be assessed pre and post the intervention period to determine the effects.

Intradialytic hypotension (low blood pressure during dialysis) is a common problem in hemodialysis patients and can lead to poor outcomes. Pneumatic compression devices (PCD) are well established in the prevention of deep venous thrombosis and pulmonary embolism. It is thought that the use of PCDs during hemodialysis will increase venous return and improve hemodynamic stability. However, there is paucity in evidence regarding the use of PCDs during dialysis. We aim to investigate the effect of PCDs on intradialytic hypotension, compared with standard of care. The study is a two-period, eighteen-treatment, randomized crossover trial. We aim to recruit between 16 and 25 patients from hemodialysis unit at Frankston Hospital. Participants will be randomised into 2 groups, either to start with PCD or without PCD. Group A participants will have 3 weeks of dialysis with PCD, then one-week washout period of no intervention, followed by 3 weeks of dialysis without PCD. Group B participants will have 3 weeks of dialysis without PCD, followed by 3 weeks of dialysis with PCD. Standard of care during dialysis will remain the same during non-treatment period and washout period. Primary outcome measured is intradialytic hypotension. Secondary outcomes are intradialytic hypotension with nursing intervention and patient symptoms, intradialytic hypotension with symptoms, lowest blood pressure less than 100 mmHg, ability to achieve dry weight, postural hypotension at the end of dialysis and maximum fluid removal. Postural hypotension is defined as a systolic blood pressure decrease of at least 20 mm Hg or a diastolic blood pressure decrease of at least 10 mm Hg within three minutes of standing.

This study will evaluate the reproducibility of magnetic resonance imaging (MRI) setup of patients in the radiotherapy treatment position and assess how this impacts the image quality for radiotherapy planning and treatment delivery. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with prostate, head and neck, central nervous system, rectal, cervix or lung cancer. Study details: Patients would otherwise be undergoing an MRI scan in the radiotherapy department for their cancer treatment or other research purposes. Patients will undergo a planning MRI scan in the treatment position then the patient would then get off the MRI couch and be set-up for a second MRI scan with limited MRI sequences. The main purpose of this study is to determine the consistency of positioning and the impact of MRI distortion, landmark positions and contours between scans.

Misoprostol and Dinoprostone are both medications used to ripen a woman's cervix in preparation for labour. In a phase III trial by Wing et al misoprostol vaginal insert, when compared to dinoprostone vaginal insert, was thought to reduce the time from insert to vaginal delivery and decrease the number of women needing further intervention by oxytocin for induction of labour by 26% without an increase in the complications of caesarean section or neonatal morbidity. Misoprostol was found to increase the rate of tachysystole (too frequent uterine contractions) to 13% compared with 4% for dinoprostone. Wing et al used both primiparous women and multiparous women in their study. We hypothesize that by using misoprostol in primiparous women only we may still be able to achieve the significant reduction in need for other interventions for induction of labour but without the significant increase in rates of uterine tachysystole. Women admitted to the study will have either the misoprostol or dinoprostone inserted for cervical ripening and data collected on whether or not they then needed to have a cervical ripening balloon for further ripening, whether they needed oxytocin for induction of labour, whether they had too many contractions that required intervention to control, what their mode of delivery was, what the time interval between when the pessary was inserted and when they delivered and whether or not there were any neonatal complications.

This proposed research will examine the feasibility of the FRAIL Screen in general practice as a screening tool for frailty and determine the impact of a high- as compared to low-quality protein supplement in combination with a centre- and home-based exercise intervention on muscle strength, physical function parameter and quality of life in frail older people who live in the community. Aims: 1. To examine, the feasibility of recruiting 120 community-dwelling older people, aged 65 years and older who have screened frail (>1) using the FRAIL SCREEN tool to a 6 months intervention study involving nutrition and exercise; 2. To determine the effects, over a period of 6 months, of exercise in combination with either (i) high-quality whey protein supplements or (ii) lower-quality rice protein supplement, on the primary outcomes of gait speed, leg press and grip strength, and physical performance, and other secondary outcomes including frailty, muscle mass, nutritional intake, physical activity, and quality of life. Hypotheses: 1. It is feasible to recruit 120 community dwelling frail older people using the FRAIL SCREEN tool through the ACH referral system and multiple proposed referral strategies. 2. It is feasible for participants to participate in the proposed nutritional and exercise supplementation program for a period of 6 months. 3. The higher-quality whey protein supplement combined with a pragmatic exercise program will result in greater improvement of gait speed and grip strength, physical performance and quality of life, and the other secondary outcomes at 3 months and 6 months than a lower quality rice protein combined with pragmatic exercise program, in older people who are frail or at-risk of frailty as determined by the FRAIL Screen.

The proposed research plans to examine the application of an ointment (Rectogesic 0.2% GTN), a pharmaceutical agent approved for human use, on venous leg ulcers. GTN ointment works in part by releasing nitric oxide (NO) into the wound, which acts to improve blood flow to the area and has the capacity to kill unwanted bacteria in the wound. The product to date has not been used routinely for the treatment of venous leg ulcers. A previous study by the chief investigator demonstrated the enzyme (iNOS), which drives the production of NO, was elevated in patients with faster healing leg ulcers, suggesting that application of a topical GTN donor (the ointment) might accelerate this healing process. The trial will be double blinded with half of the recruited patients receiving a placebo and the other half receiving the GTN donor. Neither the patients nor the research nurse involved in treatment will know if the product is the placebo or the GTN donor. The trial will run only for 4 weeks for each patient so rates of healing will be determined by planimetry (ulcer tracing) as complete healing of the ulcer will most likely not be achieved in the time frame being examined. If a statistically significant difference exists between the two groups the treatment will deemed successful. It is hoped that a subsequent larger trial will be planned based on the findings from this study. Hypothesis: Participants receiving the Rectogesic (GTN donor) will have a statistically higher linear healing rate (LHR) compared to patients that receive only the placebo.

Pancreatic cancer is a devastating disease that is set to become the 2nd leading cause of cancer-related deaths worldwide by 2020. Over 80% of pancreatic cancer patients are diagnosed with unresectable locally advanced or metastatic disease. Through data collection and correlation with analyses of archival tumour specimens and blood collections, this trial aims to identify and validate novel diagnostic and monitoring methods; novel predictive and prognostic biomarkers and to use these to inform studies of novel therapeutic opportunities that will improve the management of pancreatic cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have been diagnosed with pancreatic ductal adenocarcinoma (PDAC). Study details This protocol aims to enrol at least 500 consecutive eligible patients over 10 years. Enrolled patients will undergo collection of clinical data and archival tumour specimens. Where applicable, patients will also undergo collection of blood and/ or urine at several time points. Once a sufficient cohort has been enrolled, selected molecular analyses will be conducted on each specimen, thus, allowing for batching of specimens. Enrolled patients will undergo collection of clinical data and archival or fresh tumour specimens as part of routine clinical management, with all patients will be treated as per standard of care. When applicable, archival tissue samples from the primary pancreatic cancer, matched normal pancreas tissue and/or resected metastases will be obtained, upon enrolment. to study. Where possible, current biopsy specimens (fresh tissue) will be collected by either Victorian Cancer Biobank or local pathology laboratories at the time of standard of care procedures. Patients that consent to the “liquid biopsy” (blood and urine collection) sub-study will undergo collection of blood/plasma and urine at the beginning and during each systemic therapy. Blood (upto 60 ml) and urine (upto 60 ml) will be collected for research purposes on the following occasions: 1. Before and after surgical removal of pancreatic cancer (if applicable) 2. Before and after any chemotherapy regimen (if applicable) 3. Every 6 months while you are on active surveillance (if applicable) Follow up will occur until the end of active surveillance, death or 5 years post enrolment, whichever occurs first.