ANZCTR search results

Stargardt disease 1 (STGD1) is the most prevalent form of juvenile macular degeneration. It is caused by a rare, inherited autosomal recessive trait, leading to severe and irreversible blindness by the first or second decade of life. Earlier onset of the disease is related to a rapid vision loss, while patients with a later onset tend to have a better prognosis. This study will enrol up to 10 subjects aged 12-18 years old with a confirmed clinical diagnosis of Stargardt disease type 1 (STGD1). This study will include 2 phases, the phase 1b portion is to determine the optimal dose for phase 2 based on the extent of retinol binding protein 4 (RBP4) reduction after 2 cycles of tinlarebant treatment. The phase 2 portion will evaluate the safety and efficacy of a single daily dose of tinlarebant over a 24-month treatment period.

This study aims define the burden of GI intolerance in patients with kidney failure on dialysis and with kidney transplants, and to understand patients’ experiences of GI intolerance and their perspectives on the management strategies of these symptoms. The hypotheses: 1. GI intolerance is common in patients with kidney failure (transplant candidates) and kidney transplants. 2. Kidney transplant candidates and recipients have different experiences and perspectives of GI symptoms and intolerance. 3. Kidney transplant candidates and recipients have diverse views on the treatment preferences of GI intolerance.

The SERENITY study will look at demographic and lifestyle factors, and procedural information of patients with breast implants and lymphoma to determine risk factors for breast implant associated lymphoma Who is it for? You may be eligible to join this study if you are aged 18 and above, have had breast implant surgery and/or been diagnosed with lymphoma Study details All participants in this study will self nominate to participate by responding to the advertisements. Participants will then complete an eConsent and then a once-time electronic survey. The demographic, lifestyle and procedural information provided/gathered will be used to determine risk factors for developing breast implant associated lymphoma. It is hoped that the information captured by this study will contribute towards planning for a pilot screening program for BIAL in order to support earlier diagnosis and as such better patient outcomes.

This research aims to investigate the effectiveness of Group Clinical Supervision (GSC) within maternity units in twelve Sydney’s public hospitals. The project will explore whether regular access to GCS affects midwives’ perceptions of workplace culture, their intentions to stay in or leave the profession and actual staff retention rates. The level of midwifery burnout will be the primary outcome. The study will include a cluster randomised controlled trial (RCT) with measurement tools that include the Australian Midwifery Workplace Culture (AMWoC) survey tool, the Clinical Supervision Evaluation Questionnaire (CSEQ), the Copenhagen Burnout Inventory (CBI), and workforce data showing staff turnover rates and sick leave from maternity units within the Local Health Districts. The hypotheses are: that regular GCS will improve midwives’ perceptions of their workplace culture and lower their levels of work-related burnout; Midwives with positive perceptions of their workplace culture will be more likely to remain in their profession, and that Maternity units offering regular GCS will have lower levels of midwifery staff attrition than others.

After consuming a meal, blood glucose levels rise which results in the pancreas secreting the hormone insulin. Insulin increases blood flow in skeletal muscle (similar to exercise) and this blood flow effect helps deliver the glucose to the muscle for storage (1, 2). We have recently shown that if someone consumes only glucose in their meal this results in an impairment in muscle blood flow (3). We have recently built on this finding to show that when matched for blood glucose levels, intravenously infused glucose (which by-passes the gut) has the opposite effect and stimulates muscle blood flow (not published). Therefore, our data suggests that a gut-derived factor could be regulating the impaired muscle blood flow observed with orally ingested glucose. The aim of this project is to investigate the effects of one of these gut-hormones called Gastric Inhibitory Polypeptide (GIP) on muscle blood flow. Findings from this study will enhance our knowledge and understanding of blood flow regulation after a meal and has implications in the consumption of high glycemic-index food and drinks. References: 1. Clark MG, Wallis MG, Barrett EJ, Vincent MA, Richards SM, Clerk LH, et al. Blood flow and muscle metabolism: a focus on insulin action. American Journal of Physiology-Endocrinology And Metabolism. 2003;284(2):E241-E58. 2. Keske MA, Dwyer RM, Russell RD, Blackwood SJ, Brown AA, Hu D, et al. Regulation of microvascular flow and metabolism: An overview. Clinical and Experimental Pharmacology and Physiology. 2017;44(1):143-9. 3. Russell RD, Hu D, Greenaway T, Sharman JE, Rattigan S, Richards SM, et al. Oral Glucose Challenge Impairs Skeletal Muscle Microvascular Blood Flow in Healthy People. American Journal of Physiology-Endocrinology and Metabolism. 2018.

Heart disease is the leading cause of death worldwide. The only way to lessen the detrimental effects on the heart during oxygen poor circumstances is to re-introduce oxygen to the cells of the heart (by getting rid of the obstruction responsible for the problem). Re-introduction of blood flow and oxygen to cells that was oxygen poor however also results in damage to the cells. This is known as “reperfusion injury”, the medical world still doesn’t have a treatment option to eliminate reperfusion injury. The aim of this study is to investigate a new treatment option (melatonin) to lessen or eliminate the damage to the heart following reperfusion injury. Although we know that this treatment option is extremely effective in animals (it halved the size of heart attacks in rats), we still don’t have a clear answer to its role in humans. More research is required to determine how melatonin can benefit patients undergoing heart surgery. We thus hypothesize that preoperative, sublingual melatonin will have cardio-protective properties during reperfusion injury, and that the cardio-protection will be as a result of the anti-oxidant and anti-inflammatory effects associated with melatonin supplementation. The degree of cardio-protection, anti-inflammatory and anti-oxidative properties will be assessed by biomarkers (CRP and hsTnT levels found in blood samples). This study will be performed at two centres (Sir Charles Gairdner Hospital and Saint John of God, Subiaco) and is a prospective, randomized, double-blind, placebo-controlled, phase 2 study investigating the oral, preoperative administration of melatonin. Double-blind means that neither you nor your study doctor will know which treatment you are receiving. This research project has specifically been designed this way to make sure the researchers interpret the results in a fair and appropriate way and avoids study doctors or participants jumping to conclusions. However, in the event it is medically necessary your study doctor can find out which treatment you are receiving. The participants will be allocated into three study groups: The control group (receiving placebo with no active ingredients), the low dose melatonin group and the higher dose melatonin group.

This study aims to trial a structured professional judgment approach to the assessment and management of suicide and self-harm risk on a prison mental health unit. The ‘SLIPS’ documentation guidelines will be introduced as an additional resource to aid clinical decision making and safety planning with prisoners at risk of suicide or self-harm. It is hypothesised that the implementation of the approach will lead to a reduction in rates of self-harm behaviour, reported thoughts of self-harm/suicide, and suicide attempts over a 12-month period in a prison mental health unit. The study has an additional component of a qualitative examination of the perceptions and experiences of individuals with a lived experience of self-harm/suicidality in custody as well as staff who provide care and management to them.

Diastasis of the rectus abdominis muscle (DRAM or DRA) is a common condition postpartum where the abdominal muscles seperate along the linea alba. Current physiotherapy management is overwhelmingly reported to include transversus abdominis (TrA) training (Keeler et al., 2012), however, ultrasound imaging evidence is growing to support rectus abdominis (RA) training in the early postpartum period instead (Mota, 2014; Mota et al., 2015; Sancho et al., 2015). While ultrasound imaging has previously shown contraction of the TrA muscle increases the inter-recti distance and RA reduces it, no current evidence exists comparing the two when precribed as a treatment. References Keeler, J., Albrecht, M., Eberhardt, L., Horn, L., Donnelly, C., & Lowe, D. (2012). Diastasis recti abdominis: a survey of women's health specialists for current physical therapy clinical practice for postpartum women. Journal of women’s health physical therapy, 36(3), 131-142. Mota, P., Pascoal, A. G., Carita, A. I., & Bø, K. (2015). The immediate effects on inter-rectus distance of abdominal crunch and drawing-in exercises during pregnancy and the postpartum period. journal of orthopaedic & sports physical therapy, 45(10), 781-788. Mota, P., Pascoal, A. G., Carita, A. I., & Bø, K. (2018). Normal width of the inter-recti distance in pregnant and postpartum primiparous women. Musculoskeletal Science and Practice, 35, 34-37. Sancho, M. F., Pascoal, A. G., Mota, P., & Bø, K. (2015). Abdominal exercises affect inter-rectus distance in postpartum women: a two-dimensional ultrasound study. Physiotherapy, 101(3), 286-291.

This study will investigate immune responses to vaccination in patients with blood cancer who have received treatments targeting specific immune cells, B cells, those who have undergone bone marrow transplantation and a group of healthy volunteers who have not been treated for blood cancer or received any immune cell treatments. Who is it for? You may be eligible for this study if you are aged 18 or older, have been diagnosed with a blood cancer (including non Hodgkin's lymphoma, myeloma, Hodgkin's and leukemia) and have received either treatment with a B-cell targeted therapy or received a bone marrow transplant, and you are planning to have a COVID-19 vaccine of any variety. A second group of adults aged 18 and older who do not have a diagnosis of blood cancer or any other active cancer, who have not received treatment with B cell depleting antibodies, and who are also planning to have a COVID-19 vaccine of any variety will also be recruited. Study details Participants who choose to enrol in this study will be asked to provide up to five blood samples, starting up to 1 week beforethe first COVID-19 vaccine dose and continuing until 6 months after the second COVID-19 vaccine dose has been administered. We will also ask to review your medical records over the 12 months after you have received the second dose and may contact you to confirm any positive COVID-19 test results. It is hoped this research will enable researchers to understand how these cancer treatments affect the immune response to COVID-19 vaccination and whether vaccination will provide effective protection in patients with blood cancers.

Tonsillectomy is a painful procedure, especially in adults. Recent technological advances have allowed new methods of tonsillectomy to be performed. Radiofrequency Coblation and ultrasonic Bizact methods both claim to improve the patient’s pain post-operatively. This trial will randomise patients to one of these two methods and study post-operative pain outcomes by visual analogue pain scores and days to normal activity. Bleeding during and after surgery, and the duration of surgery, will also be measured. We hypothesize that coblation tonsillectomy will result in reduced post-operative pain, reduced primary and secondary bleeding during and after surgery, a shorter duration of surgery and faster return to normal activity when compared to the Bizact method.