ANZCTR search results

IMAGEN is a multicentre, prospective, parallel group, randomised, double-blinded placebo-controlled trial to assess if 4g of a dietary supplement daily over 12 months will reduce AAA growth. Participants who consent will undergo a thorough screening assessment for safety and suitability. Assessments include; physical and clinical examination, blood test, CT and Ultrasound of the abdomen, quality of life questionnaire and diet assessment. If the participants meet all inclusion criteria and no exclusion criteria they will be randomised (randomly allocated) to either the dietary supplement or placebo group. The participant will be blinded to the supplement name and it will be referred to as "the supplement" from the moment of initial contact. The dietary supplement and a placebo equivalent powder will be separately packaged in 500mg dose capsules. The capsules will be dispensed by an independent and unblinded pharmacist. Participants will be instructed to have four 500mg capsules twice per day at 8am and 8pm. Participants will revisit the site centre at 6 and 12 months after starting the trial to monitor adverse events, compliance and perform assessments. Participants will be contacted by telephone at 1, 3 and 9 months to monitor compliance and adverse events. The team will consist of experienced investigators, vascular surgeons, coordinators and researchers at each site. A steering committee, data and safety committee and publications committee will be established to oversee various aspects of the study to ensure the aims of the study are met while upholding the protocol

Background The effects of FIFA 11+ warm-up program for soccer injuries prevention have been evaluated in several studies. However, the importance of a ‘warm down’ using the FIFA 11+ protocol additional to the warm up has not been investigated and yet may be important. Participating in the 11+ in the fatigued state may challenge the athlete and translate directly into real ‘game-like’ conditions. Objective The main objective of the study is to test whether the intensive FIFA 11+ warm-up combined with warm down program has an additional effect on the incidence, severity of injuries and adherence, compared to the FIFA 11+ warm up alone, among amateur soccer players. . The ‘11+’ before and after the training sessions is hypothesized to reduce the incidence of injury among male amateur soccer players. The prevention of such injuries will be beneficial to soccer players, clubs, football associations, health insurance companies and society. Study design Cluster-randomized controlled trial Methods Male amateur soccer players, aged 18–30 years, will be allocated to interventions or control group. Both groups will perform FIFA 11+ 15 exercises for 20 minutes as a warming up with regular soccer training. The intervention group will additionally perform FIFA 11+ 13 exercises for 10 minutes as a warm-down with every training session. Primary outcome measures are the incidence of initial and recurrent injury and injury severity. A secondary outcome measure is the rate of compliance.

Burns to the face are very common among children. They are caused by scalds from hot liquid or less commonly flash flame burns. Care for burns to the face usually require admission for pain management and regular cleaning with saline soaked gauze (up to three times a day) followed by the application of white soft paraffin (every two to four hours) throughout the day. We are trialling a new product, Glucan Pro 'Registered Trademark' 3000, an ointment that contains paraffin wax and other active ingredients mainly oat beta glucan, an oat derivative which is currently indicated for the management of superficial abrasions, scrapes, and cuts. It has been used for non-facial burns in children with good results Aims: 1) Length of stay: Glucan Pro 'Registered Trademark' 3000 provides an occlusive layer similar to white soft paraffin for wound healing, however the active ingredients (oat beta glucan) has been shown to have a beneficial effect in nonfacial burns. We hypothesise that Glucan Pro 'Registered Trademark' 3000 application to facial burns will acclerate the healing process and result in a reduction in length of hospital stay. 2) Reduction in frequency of application: The current standard of care includes the application of white soft paraffin (every 2-4 hours) to keep the burn wound moist. We hypothesise that Glucan Pro 'Registered Trademark' 3000 will result in a reduction in frequency of application and thus provide a more comforting environment for the paediatric patient. Adverse event: There is a small risk of an allergic reaction with topical treaments (ie. rash), and if this occurs we will stop using the product, seek appropriate medical advice and revert to the usual course of treatment. If infection is identified, participant will be withdrawn from the trial and appropriate medical management will be instituted. All adverse events will be reported to the Department of Pharmacy, Clinical Governance Unit and Women’s and Children’s Health Network Ethics Committee. Analysis: Results of the trial will be analysed using the intention to treat (ITT) methodology. Daily wound review checklist will be analysed to determine variability in the frequency of application of each product Trial review: Conduct and progress of the trial will be reviewed and updated weekly Burns Research/Business Meeting (Wednesday, Level 2, Surgical Services) What are the possible risks: There is a small risk of an allergic reaction with topical treaments (ie. rash), and if this occurs we will stop using the product, seek appropriate medical advice and revert to the usual course of treatment. There may be no direct benefit from the use of Glucan Pro 'Registered Trademark' 3000

Aims: This pilot trial aims to evaluate the safety and tolerability of a Traditional Chinese Medicine herbal combination “AL” (Astragalus membranaceus and Ligustrum lucidum) in people with advanced cancer. It will also investigate whether AL can improve the immune function Who is it for? You may be eligible to join this study if you are aged 18 years or older and have been diagnosed with recurrent or metastatic cancer or have declined or are ineligible for further treatment. Study details All participants in this study will receive AL herbal treatment and take 12 capsules of AL each day for 12 weeks. The study treatment is a combination of two herbal medicines known as “AL” (Astragalus membranaceous and Ligustrum lucidum). “AL” consists of herbal medicines, which have been used together for many years in China especially in people undergoing cancer treatment. “AL” is commonly available as a registered product in China called Zhenqi Fuzheng Capsule. This product is registered by the China State Drug Administrations as a prescribed medicine (Z62020414). At least 17 clinical studies have investigated this combination AL using this same product Zhenqi Fuzheng Capsule in people with cancer who have undergone standard chemotherapy or radiotherapy treatments. We know from studies in other people with cancer that “AL” is usually well tolerated. It is possible that “AL” may help lessen some of the side-effects of cancer treatment – but this is the focus of future studies. The results from this study will be used to design future studies looking at combining these herbal medicines with current treatments. Participant will complete fatigue and quality of life questionnaires, and donate blood for tests at baseline, during AL treatment and after.treatment The ability of participants to tolerate AL will be determined by their treating physician.

The purpose of this study is to investigate whether improved radiation planning technology that conforms to the shape and size of the cancer, can be used to treat multiple sites of cancer within the brain, and at the same time protect and preserve brain (memory and cognitive) function. This study is for patients who are are aged 18 years or above and have been diagnosed with 3-10 cerebral metastases, i.e. the cancer has spread to three or more spots on the brain. All participants in this study will receive a new treatment called Hypofractionated Stereotactic Radiotherapy. This is highly focused radiation given in one to five treatments. Robotic targeting is used to avoid important parts of the normal brain. Whereas previous treatment for multiple sites of cancer within the brain has involved giving radiation to the whole brain, this treatment will allow for targeted treatment of just the affected areas. In this way, the dose of radiation delivered to key areas of the brain involved with memory function can be minimised. All participants will be monitored throughout treatment for safety. At the beginning of the study, and then at 3 and 6 months following treatment, patients will be asked to undergo MRI scans to assess disease control, have assessments of neurocognitive function by a trained neuropsychologist, and complete quality of life questionnaires. We estimate that this study will contribute further to the research into using radiotherapy to control cancers that have spread to the brain, while minimising the effects on brain function.

The study is to assess the safety and tolerability of PTG-100 to normal healthy volunteers. This includes vital signs, safety labs and physical examinations The drug will be given in single ascending then multiple ascending doses. The study will also evaluate the PK of the drug after dose administration. Participants will be entered into standard study cohorts

Objectives of this study are to assess the effects of the remote ischemic preconditioning (RIPC) on the primary graft failure (PGF), heart function and multi-organ protection after heart transplantation. This is a prospective, multi-centre, double-blind randomized controlled clinical trial (RCT). The outcome of the study is expected to determine if significant protection by the RIPC previously achieved in animal study can be translated into clinical heart transplantation. Study Duration: Three years. Intervention is the RIPC stimulus (also referred to as ‘protocol’) which consists of four five-minute cycles of arm ischemia with intervening five minutes of reperfusion following induction of standard anaesthesia in the operating room, prior to heart transplantation (HT). Inflating a standard blood pressure cuff to a pressure exceeding systolic by 20 mmHg will interrupt blood flow. The cuff would be deflated during reperfusion. Control patients will have sham placement of cuff without inflation. Participants will be monitored after HT and an analysis of blood samples (involving an examination of markers of myocardial damage, i.e., troponin I) collected as a part of standard care will be used to determine if there are protective effects due to the RIPC protocol used. Number of Subjects: 50. Population: Adults and children aged >15 years undergoing heart transplantation for the first time.

This randomised placebo-controlled trial will recruit 210 patients following an acute myocardial infarction (MI). They will be randomised to colchicine 0.5mg once daily or matching placebo for 30-days. Patients, health-care providers, data collectors and outcome adjudicators will be blinded to treatment allocation. Randomisation will occur within 7 days of the index MI and will be stratified by study centre. Baseline clinical data, including concomitant medications, serum biochemistry, full blood count and creatine kinase will be recorded. These blood tests will be repeated at 30 days. Levels of C-reactive protein (CRP) will also be measured at baseline and at 30-days. Patients with a type 1 MI (using the 3rd universal definition) will be eligible for inclusion unless they have a know contraindication to, intolerance of or clear indication for treatment with colchicine. The primary aims of this study are to provide data regarding the feasibility, tolerability and safety of low-dose colchicine after acute MI. The secondary end-points relate to the ability of colchicine to reduce CRP. Data from this trial will be used to inform the design of a larger outcome trial.

The primary purpose of this study is to examine the fertility-related quality of life and psychological distress in young cancer patients and their parents/carers compared to individuals of the same age receiving a fertility consultation for fertility problems which are not related to cancer. Who is it for? You may be eligible to participate in this study if you are aged 15-25 and have been diagnosed with any cancer in the previous [0-90 days from diagnosis], or are receiving a fertility consultation for fertility problems which are not related to cancer. Parents/carers/partners of enrolled cancer patients may also participate. Study details: Cancer patients and non-cancer related fertility problem groups will complete one questionnaire at enrolment into the study, and then the same questionnaire at 12 months and three years’ post-treatment. Participants will also complete two sixty-minute semi-structured telephone calls at the enrolment, 12 months and 3 year time points. Parents/partners of cancer patients will complete one questionnaire and two-sixty minute semi-structured telephone interviews at three different time points which will include: at the patient’s cancer diagnosis, 12 months and three years post-treatment. All participants will be asked about their quality of life and psychological distress related to their infertility or their child's/partner’s infertility. Researchers will use the data collected from questionnaires and interviews to investigate the short and long term effects on mental health, quality of life and meaning of parenthood in these young adults. It is hoped that the findings of this study will inform healthcare providers of the psychological effects of cancer-related infertility in young people.

We will conduct a cluster randomised trial (60 groups of older people) to evaluate two healthy ageing strategies among community-dwelling people who attend established community-based groups. The primary objective is to measure the effectiveness of: a) a physical activity and fall prevention intervention including telephone-based health coaching and written information on physical activity and falls over a 12 month period, and b) a nutrition intervention including telephone-based health coaching and written information on eating habits over 12 months. The trial also aims to establish the impact of the interventions on physical activity guideline adherence, eating habits, body mass index, goal attainment, mobility confidence, quality of life, fear of falling, risk taking behaviour, wellbeing and mood.