ANZCTR search results

This aim of this study is to explore the emergence of RAS mutations as an escape mechanism in patients receiving first-line cetuximab anti-EGFR therapy in combination with FOLFOX or FOLFIRI as well as to demonstrate the general utility of cfDNA RAS mutation monitoring as compared to standard care measurements of treatment resistance and disease progression using CEA and imaging. 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 metastatic colorectal cancer. Study details All participants in this study will receive first line anti-EGFR antibody (cetuximab) therapy in combination with either irinotecan-based (FOLFIRI) or oxaliplatin-based (FOLFOX) chemotherapy, as chosen by their treating medical oncologist. To examine the emergence of RAS mutations during anti-EGFR therapy, serial blood samples (30mls) will be collected from patients. The timing of emergence and genotype analysis of RAS mutations from cfDNA in patients undergoing 1st line treatment with cetuximab in combination with FOLFOX or FOLFIRI will then be examined. For all patients, disease progression will be examined by comparing RAS mutation levels to routine CEA assessment and imaging. Patients having RAS WT tumours and receiving first-line cetuximab therapy in combination with FOLFOX or FOLFIRI will be monitored until documented tumour progression.

Osteoarthritis is a major cause of pain and disability worldwide. Recent research and clinical evidence indicates that Human adipose-derived stem cells are safe for use in Humans. Researchers suggest that the treatment may alter the operation of the immune system to ameliorate degenerative activity. In a conducive environment supported by a combination of growth factors and certain other peptides, stem cells can also be stimulated to differentiate into a range of different cell types facilitating tissue regeneration. In addition, clinical practice using adipose tissue implants indicates that site stability and health is improved with less processed, tissue fractions. In the regulation of therapeutic goods, controversy has arisen concerning the lack of regulation on treatments that involve a high degree of cellular manipulation. The Lipogems product is extracted from the patient’s adipose tissue using a minimal and subtle, physical process without need for enzymatic digestion or cell culturing. This trial is investigating to what extent moderate to severe Osteoarthritis of the knee is modified by an injection of an adipose tissue fraction (Lipogems) obtained from the participants own fat tissue and two different blood extracts : (1) Platelet-Rich-Plasma which contains growth factors released from platelets and endogenous fibrin scaffold which is used to stimulate the natural healing cascade and tissue regeneration directly at the site of treatment; (2) Orthokine, a conditioned blood serum rich in the anti-inflammatory cytokines particularly IL-1Ra which is thought to alter the progression of OA by neutralizing pro-inflammatory cytokines. These treatments are applied in combination with proprietary peptides which are derived from those that are naturally present throughout the body and are critical to cellular processes particularly growth and regeneration. Age and disease conditions can reduce the levels and effectiveness of these peptides which normally promote healing.

Muscle tears are a common injury in athletic populations. This exploratory study will involve a randomised trial comparing the effects of Traumeel with placebo in the treatment of acute muscle strains, specifically those of the hamstring muscles. This substance is used extensively in Europe for treatment of muscle injuries, however, there is no available evidence base for the use of these treatments. Due to this lack of evidence these treatments are not offered as standard practice to Australian athletes. Investigating these treatments that may provide additional options for injured athletes is a priority in reducing training days lost to injury.

It’s a clinical trial of a drug called Ibopamine, to be used in a challenge test in much the same way as a water drinking test. Ibopamine is an alpha, beta and dopamine receptor agonist, which causes a brief increase in aqueous production for about 4 hours after a single drop. Among normal patients, this causes no change in intraocular pressure, but in glaucoma patients, IOP will increase. My suspicion is that the degree of IOP rise might be related to the patient’s likelihood of further progression in the future. I have recently completed a pilot case-control study which has successfully shown that an ibopamine challenge can differentiate between glaucoma suspects, stable glaucoma patients and patients whose glaucoma is rapidly worsening. Now, I would like to commence a longitudinal study investigating the predictive value of a positive ibopamine challenge among glaucoma suspects and early glaucoma patients.

At The Royal Children's Hospital (RCH) Melbourne, there has been a change in clinical practice with the increased prescription of nebulised Hypertonic Saline (HTS) (3% or 6%) compared to Normal Saline (NS) (0.9%) prior to chest physiotherapy in children with severe neurological impairment and acute lower respiratory tract infection (LRTI). Historically NS (0.9%) has been administered when secretions are thick and difficult to expectorate (Hull et al., 2012; McCrea et al., 2013). This pilot study aims to address the questions, “Is a trial comparing nebulised HTS (6%) compared to NS (0.9%) before chest physiotherapy in children with severe neurological impairment and acute LRTI feasible in Paediatric Intesive Care Unit (PICU)” and “Is there any indication of a difference in short-term respiratory outcomes when participants are given nebulized HTS (6%) compared to NS (0.9%) before chest physiotherapy in children with severe neurological impairment and acute LRTI that warrants a larger, definitive study?”

This is a double blinded prospective randomised trial to investigate the effect of methadone and bupivacaine on the development of chronic pelvic pain in women undergoing surgical management of endometriosis. Chronic pelvic pain is common in women with endometriosis, and can develop despite surgical treatment of the disease. Endometriosis causes pain in a variety of mechanisms including direct compression/infiltration of nerves by the lesions, inflammation, and damage to pelvic nerves during surgery and may lead to changes in the central nervous system which propagate chronic pain. The objective of this trial is to prove that active management of intra-operative analgesia with intravenous methadone and intraperitoneal bupivacaine, for women with long-standing pain from moderate to severe endometriosis leads to long-term benefit in terms of pain experience and quality of life. Patients will be recruited from the endoscopy clinic at King Edward Memorial Hospital. They will be eligible if they have an American Fertility Society Score of 2 or 3 on previous laparoscopy and are planned for laparoscopic treatment on endometriosis. At recruitment patients will undergo a visual analogue scale (VAS) assessment for pain and will complete a quality of life (QOL) assessment. Patients will be randomised to either the standard analgesia group (IV fentanyl 5mcg/kg + placebo (200ml saline) intraperitoneal) or the intervention group (IV methadone 0.2mg/kg and 200mL levobupivocaine 0.625% intraperitoneal). Repeat pain scores will be recorded on day 1, and repeat pain scores and QOL scores at 6 weeks, 6 months and 12 months post-operatively.

Rotator cuff tears are the most common condition affecting the shoulder. Conservative treatment can involve pain medication, corticosteroid injection, activity modification and physiotherapy. Surgical treatment is considered when conservative management has failed and quality of life is significantly impacted by shoulder dysfunction. In the rehabilitation phase following rotator cuff repair, patients follow a set protocol determined by the surgeon. There is currently no agreement on whether one rehabilitation approach is better than the other. One study found that patients that underwent a shoulder program for 4-6 weeks before surgery had better function and reduced pain in the rehabilitation phase compared to a delayed program group. Pre-operative programs for patients scheduled for spinal surgery and total knee replacements have demonstrated some encouraging results. This type of program has not been used for patients awaiting rotator cuff surgery. The effects of such a program on patient post-operative expectations, function and quality of life have not been investigated. The purpose of this research is to investigate whether the addition of a prehabilitation program to routine pre-operative care will result in better function, quality of life and post-operative expectations for patients awaiting shoulder surgery. The second aim of this research is to study the effect of prehabilitation on pain, shoulder range of movement, strength and exercise endurance. In addition, it may possibly reduce the need for surgery. It is hypothesised that addition of prehabilitation to optimise physical and mental preparation will improve post-operative outcome than usual care (waiting list).

The gene transfer product Cal-1 aims to protect CD4+ T lymphocytes and blood cells from CD34+ bone marrow stem cells from HIV-1 infection. The protective effect may suppress the HIV-1 RNA plasma viral load and maintain the CD4+ T lymphocyte count in a treated individual, thereby decreasing or delaying (either partially or completely) the need for ART. The purpose of this study is to help determine whether Cal-1, as well as the method used to deliver Cal-1, is safe in people. Cal-1 is an experimental treatment for HIV-1 infection. This means that Cal-1 is not an approved treatment for HIV-1 in Australia. Cal-1 has already been tested in the laboratory and in animals, this study is part of the first stage of testing Cal-1 in people. We aim to collect preliminary information on whether Cal-1 can protect the person’s immune system from the effects of HIV by reducing HIV-1 viral load and/or preventing further decline in T cell counts.

This study aims to measure the effectiveness of Acceptance and Commitment Therapy in reducing distress and increasing positive wellbeing in Adolescent and Young Adults (AYAs) who are offspring (children) of cancer patients. Who is it for? You may be eligible to join this study if you are aged between 14 and 22 years and have a parent or caregiver with a current (last 5 years) diagnosis of cancer, who is not currently in palliative care or terminal. Study details: Participants in this study will receive Acceptance and Commitment Therapy (ACT) in small group sessions administered by 2 psychologists/social workers trained in ACT. Sessions will be conducted weekly in 1.5-2 hour sessions across seven weeks. ACT is a psychological therapy designed to help people find new ways of managing their difficult thoughts and feelings by changing how they respond to them. ACT teaches skills in mindfulness and also ways to commit to values-based living despite difficult circumstances. Completion of 6 homework tasks, administered weekly is also required. Participants who are interested in the program but unable to attend the group or if it is not available in their area, will be provided with an informational booklet until eligible/available for group participation. All participants will be asked to complete some questionnaires at baseline, post-intervention and 2 months post intervention in order to evaluate their levels of distress, depression and their psychological wellbeing.

Acute exercise increases skeletal muscle insulin sensitivity for hours after exercise by mechanisms that are incompletely understood. The aim of this project is to examine whether increases in markers of bone remodelling including undercarboxylated osteocalcin (ucOC, a hormone secreted by the skeleton) following exercise is related to increases in insulin sensitivity (placebo), and whether attenuation of the increase in ucOC following exercise (by a single dose of prednisolone, a glucocorticoid) reduces insulin sensitivity and muscle insulin signalling activity post-exercise. This project will bring new insights into the connection between exercise, bone and glucose control. Understanding this connection may lead to new pharmacological and non-pharmacological interventions for the prevention and management of type 2 diabetes.