ANZCTR search results

Developing recurring mastitis is an area of research where there is little published work. Studying mastitis management after childbirth may lead to improved understanding of the outcomes for breastfeeding duration. We therefore wish to conduct a Randomised Control Trial (RCT) that will examine the outcomes of ‘Self-Management’ of mastitis versus ‘Usual Care’ in breastfeeding women following childbirth. The study intends to: Measure the prevalence of mastitis in a population of breastfeeding women. Measure breastfeeding duration and exclusivity in a population of breastfeeding women. Trial the ‘Self-Management’ of mastitis intervention. Measure women’s beastfeeding confidence. Hypotheses Self management of mastitis lowers the rate of GP visits Self management of mastitis increase breastfeeding confidence Self management of mastitis increase breastfeeding duration Self management of mastitis increase breastfeeding exclusivity

This study aimed to develop and pilot test a computer-based psychological treatment for co-occurring depression and alcohol/other drug use problems. Computer-based treatment was compared with a therapist-delivered treatment that was identical in content, and both of these treatments were compared with a brief treatment control group of one-session. It was hypothesised that people with co-occurring depression and alcohol/other drug use problems would attend and report benefits from a computer-based psychological treatment targeted at their conditions; that people in the therapist- and computer-delivered treatments would report similar reductions in depression and alcohol/other drug use over time, and that participants in both of these treatments would report superior reductions in depression and alcohol/other drug use problems than the brief intervention control group.

Shoulder arthroscopy, or keyhole surgery of the shoulder, has been an accepted form of surgery for many years. The surgery can be performed with the patient sitting upright (beachchair position), or lying on their side. Both techniques have been performed successfully for many years. The choice is usually dependent on the professional experience and preference of the surgeon. One of the research investigators, typically performs this surgery in the upright position. Some medical professionals are of the opinion that performing shoulder arthroscopy in the upright position, can affect flow of blood to the brain. This is not something that has been conclusively demonstrated by research to date. We use a technique of anaesthesia that we believe is very safe and is used widely throughout the world. Further, we are of the opinion that it does not adversely affect flow of blood to the brain. The surgery will be performed using the anaesthetic technique that we use for the majority of the surgeon’s cases. The patient will receive a nerve block that will anaesthetise the arm receiving surgery. This will be combined with either a general anaesthetic or intravenous sedation. We will use an ultrasound probe to monitor the flow of blood in the major arteries in the patient’s neck. This will give us an indication of the flow of blood to the brain. The increased monitoring will ensure patient safety during the procedure, as we will be able to detect previously unknown side-to-side differences in blood flow in the individual patients. The research will help us prove to others unfamiliar with the technique, that it is safe for this surgery.

Aim To investigate the effects of regular consumption of foods enriched in LKF during and following energy restriction on body composition and heart disease risk factors in overweight individuals. Hypotheses Regular consumption of foods enriched in protein and fibre derived from LKF during energy restriction will enhance the loss of body weight and body fat mass and result in greater improvements in heart disease risk factors in overweight individuals Regular consumption of foods enriched in protein and fibre derived from LKF will improve the long-term maintenance of weight loss and cardiovascular health benefits in overweight individuals

There is no known cure for OA and no intervention demonstrated to slow disease progression or delay time to joint replacement surgery. Currently patients are managed symptomatically with all clinical guidelines recommending paracetamol as 'the preferred long term oral analgesic'. This recommendation is based on the increased risk of serious gastrointestinal, cardiovascular and renal diseases with long-term NSAIDs use in older people. However, NSAIDs appear to provide better pain relief for patients with more than mild joint pain. Amongst patients with OA, there is much demand for the dietary supplement glucosamine and chondroitin. Marketing has led to the belief these products are able to slow the rate of joint destruction and cartilage loss and help ease joint pain with little risk of side effects. However, the few trials conducted to date have been inconclusive. A total of 600 patients with knee OA will be randomly allocated to glucosamine sulphate and chondroitin sulphate or matching placebo capsules for two years. Participants will be required to take four capsules, once daily for two years. Clinic visits for assessment, including knee radiographs, will be required at the start of the study as well as 1 year and 2 years later. The main outcomes will be the rate of joint space narrowing, knee pain and physical disability. If glucosamine results in slowing disease progression or in reducing pain, the widespread use of this product would effectively decrease pain, disability and possibly NSAIDs-related illnesses amongst the increasing number of people with OA.

About 1 in 10 Australians have persisting or chronic low back pain. Most are managed in primary care and the most frequently prescribed treatment is exercise. Chronic low back pain remains a major health problem because not all patients respond to each treatment so on average treatment effects are small. At present there are no guidelines to help clinicians select the best treatment for a patient. As a result, time and money is wasted on treatments which ultimately fail to help the patient. Our proposed study is a direct comparison of the two most promising types of exercise approaches used in Australia: a graded activity program where patients perform an individualised, whole body exercise program, and a motor control program, where patients perform a series of specific spinal stabilisation exercises. This study will compare the effects of these two interventions. We will also identify patient features that may predict a patient's response to treatment. Prediction features used will be clinical/demographic data, measures of beliefs and attitudes about pain, measures of physical activity and fitness, measures of control and co-ordination of the lumbar spine and pelvis.

The primary objective of this study is to evaluate the safety of multiple doses of Staphylococcal protein A (PRTX-100). Patients may be enrolled into 1 of 3 dose groups. A Safety Committee will review safety data through Day 28 for the first 5 patients in a dose group. Only upon the Safety Committee's approval will the next higher dose group be enrolled and dosed.

This is a phase I study to investigate the safety and feasibility of administering unrelated, tissue-unmatched, bone marrow-derived mesenchymal stem cells in recipients of allogeneic haematopoietic stem cell transplants who develop serious, treatment-resistant graft-versus-host disease. Such graft-versus-host disease is frequently fatal. In early studies in the USA and Europe mesenchymal stem cells appear to have a beneficial effect in this setting. No formal studies have been conducted yet in Australia.

TITLE Randomised, double-blind, placebo controlled study to assess efficacy of topical nicotinamide in the treatment and prevention of actinic keratosis. INTRODUCTION Background: The incidence of skin cancer has reached epidemic proportions. In Australia, despite public health campaigns and widespread sunscreen use, more than 50% of all Caucasian Australians develop non-melanoma skin cancer (NMSC) during their lifetime1, and more than one in 30 will develop melanoma.2 Ultraviolet radiation (UVR) from sunlight is the major cause of NMSC. In humans, both the UVA and UVB wavebands cause immunosuppression and DNA damage and therefore both UVA and UVB are likely to contribute to induction and development of NMSC.3,4 Immunosuppression enhances skin carcinogenesis5, as seen most dramatically in immunosuppressed transplant patients, who have an 82-fold increase in squamous cell carcinoma (SCC) compared with immunologically competent controls.6 Broad-spectrum sunscreens, which filter both UVB and UVA can reduce UV immunosuppression, but sunscreens are generally much better at preventing sunburn than immunosuppression.7,8 Current cosmetically acceptable sunscreens are poorly effective at filtering wavelengths bordering the visible spectrum. As immunosuppression can occur with less than half the amount of UV needed to cause sunburn9, the immune protection afforded by sunscreens “in the field” is likely to be low. Oral nicotinamide (vitamin B3) is available as an over-the-counter vitamin supplement and has been effective for over 50 years in the treatment of autoimmune and inflammatory skin disorders including bullous pemphigoid and rosacea.10 Unlike nicotinic acid, nicotinamide does not cause significant vasodilation or flushing11 and has few or no potential side effects. Although the exact mechanism of action in these settings is unknown, nicotinamide is a known endogenous inhibitor of the nuclear enzyme poly-ADP-ribose polymerase (PARP), which regulates the expression of immunomodulatory proteins such as inducible nitric oxide synthase, ICAM-1, MHC II and NF-kB.12 Nicotinamide is the precursor of NAD and thus a central building block of cellular energy metabolism. In mice, nicotinamide prevents UV-induced carcinogenesis and reduces skin cancer numbers by 60% when applied as a 2.5% lotion.13 Using a delayed type hypersensitivity model our group has demonstrated that nicotinamide lotion completely prevent UV immunosuppression when applied in a double-blinded placebo-controlled manner to the backs of healthy human volunteers. (Submitted for publication). In a subsequent dose-response study, topical nicotinamide was found to be immune protective at concentrations as low as 1%; it could thus be safely and cheaply added to sunscreens or moisturisers to reduce UV immunosuppression and potentially treat or prevent actinic keratosis, premalignant lesions which act as a surrogate marker for squamous cell skin cancers. Aims: This study will compare how effective topical nicotinamide is in the treatment and prevention of actinic keratoses when compared with a placebo lotion over a six month period. Hypothesis: That the twice daily application of topical nicotinamide will reduce the number of new and existing actinic keratoses in a patient population with multiple actinic keratoses when compared with placebo. RESEARCH PLAN AND METHODS Participants Patients to be recruited from general dermatology clinics in RPA. Inclusion Criteria Men and women > 18 years old. Symmetrically distributed non-hyperkeratotic AKs on face / scalp/ upper limbs. Minimum of 4 AKs in one or more treatment areas. Patients have received no other treatments for AKs within the last month. Exclusion criteria Under 18 years old Pregnant or lactating Taking immunosuppressive or photosensitising medications Taking nicotinamide or other vitamin supplements Patients unable to attend for regular follow up Patients with active dermatitis Settings and Location Department of Dermatology, Royal Prince Alfred Hospital, Sydney, NSW. Interventions Volunteers will be randomized to receive either nicotinamide 1% lotion twice daily (bd) or placebo. Blood levels of nicotinamide (NAD) will be measured at baseline and at the completion of the study. Study drug or placebo will be provided to the patients in identical containers and the formulations will be visually indistinguishable. Each patient will be instructed to apply the lotion to the prescribed treatment area twice daily for six months. Containers are returned at each visit and the contents weighed. All patients will be instructed on proper daily use of sunscreens of SPF 30 or greater during the entire study as well as general protective measures. Objectives 1. To compare the efficacy of topical nicotinamide in the prevention of new actinic keratosis with placebo. 2. To compare the efficacy of topical nicotinamide in the treatment of actinic keratosis with placebo. Outcomes The primary endpoint will be the reduction in total A.K. count at 6 months from baseline. A single observer will count and photograph AKs within the fields of treatment. AKs will be graded as II (visible and palpable) or I (palpable only). Patients with thicker hyperkeratotic AKs (III) will be excluded. There will be a secondary endpoint of total A.K. count at 12 weeks to account for appearance of new / subclinical lesions. All adverse events will be reported. The treatment efficacy compared to placebo will be calculated based on intention to treat. Sample size Based on a power of 80% and an average AK count of 10 AKs per patient and a predicted 20% reduction in AK count for nicotinamide treated patients compared to placebo treated patients, a sample size of ~40 patients in each study arm will be required to demonstrate a statistically significant difference using 95% confidence intervals. Should nicotinamide prove more effective at reducing the total AK count at six months, the total sample size required will be reduced. Randomization Sequentially numbered identical containers of nicotinamide and placebo will be randomised at source. Patients and investigators will be blinded to group assignment until the study end. Each patient will be individually randomized so that the code can be broken for a given patient should that need arise ( e.g adverse event) Statistical methods Statistical support is available through Patrick Fitzgerald, senior biostatistician in the University of Sydney. Subgroup analyses will include the effect of age, skin type, and treatment site on efficacy. Adjusted analyses will include the intention to treat population excluding those that withdraw prior to any use of the treatment. Significance of the project: Our preliminary studies have identified an effective topical and oral means of reducing UV immunosuppression in humans, using a compound, which is not limited by toxicity, patent, availability or expense. Changes in numbers of lesions in patients with multiple actinic keratoses can be observed within a period of 6 months.16 We predict that application of topical 1% nicotinamide will result in a 20-40% reduction in actinic keratoses. Confirmatory findings could pave the way for larger scale clinical trials of this agent in high-risk patients to assess subsequent impact on rates of NMSC. In Australia, with more than 374 000 new cases of NMSC each year1, even a modest protective effect of nicotinamide would greatly reduce the morbidity and cost of actinic disease.