ANZCTR search results

The study aims to address the lack of high level evidence to support the use of silver fluoride application as an accepted community treatment intervention for deciduous dental caries. Hypotheses: That silver fluoride and atraumatic restorative treatment (ART) are equally effectively in successfully managing untreated cavitated dental caries in the primary dentition. That silver fluoride has an additional benefit of reducing future development of new dental caries relative to ART. Aim: 1. To evaluate the effectiveness of silver fluoride applications in minimizing negative sequelae of dental caries in young children compared with ART. 2. To evaluate the preventive effect on the development of new carious lesions of silver fluoride compared with ART.

There is currently no approved curative therapy for infants with MCT8 deficiency. Treatment for individuals with this disease aims to provide relief for any symptoms (e.g., treatment with propylthiouracil to reduce the symptoms of peripheral hyperthyroidism) and support in the care of the patient. No treatment up to now has shown to alter the ultimate progression of neurological impairment DITPA is a thyroid hormone analogue with an MCT8 independent neuronal uptake. As a thyroid hormone receptor antagonist, DITPA is known to have distinct thryiod hormone effects on the cardiovascular system, such as an increase in left ventricular systolic performance, improvement of diastolic function, and a decrease in peripheral vascular resistance. Furthermore, DITPA is known to decrease serum lipoproteins and body weight.

Patients with chest pain presenting to the emergency department are stratified according to likelihood that the pain is due to a heart attack. “Intermediate risk” chest pain may be cardiac in origin but is not due to a heart attack, and requires further follow up. According to current Australian guidelines, these patients should be referred for an exercise stress test within 72 hrs to further clarify their risk. Currently only 30% of patients with intermediate risk chest pain present for their stress test within 72 hours even if stress testing services are readily available on site. We are investigating whether a fixed appointment time given to the patient before they leave the ED results in an improved follow up rate and improved 1 month outcome.

The aim of this pilot study was to establish if a home-based progressive resistance exercise program was feasible and then determine if there was clinical improvement in the healing rates of venous leg ulcers as a result of the intervention. Secondary aims were to examine if participation in the home-based program improved calf muscle pump function or the physical fitness parameters measured as part of this pilot study.

My study is to investigate the possible benefit of lower limb compression stockings on recovery following an endurance running event. I will ask the participants to perform a 10km running time trial on a treadmill with heart rate and perceived exertion monitoring. This will be done 2 weeks before and 2 weeks after the Melbourne marathon. The participants will be given either compression tights with a high compressive value or tights with no compression to wear for 48 hours after the marathon. They will be asked to record muscle soreness and fatigue levels in the 7 days following the marathon.

The primary objective of this study is to investigate if chlorogenic acid will increase circulating nitric oxide and if these effects are associated vascular benefits.

The objectives of this pilot study are to determine the extent to which large bowel bacteria are capable of releasing esterified butyrate in FAP patients and to determine the acceptability of butyrylated high amylose maize starch in this participant group. This study will consist of three double blinded randomised cross over studies and the objectives will be determined by feeding 3 different doses of the butyrylated high amylose maize starch to FAP patients and measuring butyrate levels in their faeces. This study will provide information on the optimal dose for FAP patients to release esterified butyrate which will be used in a major clinical trial.

This is a Phase 3, multicenter, placebo-controlled, randomized, double-blind study to evaluate the efficacy, safety, tolerability, and immunogenicity of epratuzumab in subjects with moderate to severe general systemic lupus erythematosus (SLE). The study population consists of subjects (>=18 years of age) receiving a stable dose of corticosteroids (5 to 60mg/day prednisone equivalents) for at least 5 days (±1 day) prior to Week 0 (Visit 2) and the first dose of study drug. Subjects must have a diagnosis of SLE by the American College of Rheumatology (ACR) revised criteria, such that at least 4 (not including Neurologic Disorder) of the 11 criteria are met (if positive for Neurologic Disorder criteria, a total of 5 of the 11 ACR criteria must be met). In addition, subjects must have British Isles Lupus Assessment Group (BILAG) Index (version 2004) level A disease activity in at least 1 body/organ system, or BILAG level B disease activity in at least 2 body/organ systems at Baseline among the BILAG-defined mucocutaneous, musculoskeletal, or cardiorespiratory body systems, and active moderate to severe SLE disease activity as demonstrated by a Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) total score of at least 6. Approximately 1053 subjects will be enrolled to randomize 780 subjects in this study. For each subject, the study will last a maximum of 54 weeks and will consist of a Screening Period (1 to 14 days), a double-blind Treatment Period consisting of four 12-week treatment cycles (48 weeks total), and a Safety Follow-Up Visit for subjects not participating in the open-label extension study, SL0012, at 13 weeks from their final dose of study drug, or a maximum of 4 weeks beyond Week 48 (ie, no later than Week 52). Eligible subjects will be randomized in a 1:1:1 ratio as follows: Epratuzumab 600mg infusions delivered once a week (QW) for a total of 4 weeks (cumulative dose [CMD] 2400mg) over four 12-week treatment cycles (ie, Weeks 0, 1, 2, 3, 12, 13, 14, 15, 24, 25, 26, 27, 36, 37, 38, and 39) Epratuzumab 1200mg infusions delivered every other week (QOW) for a total of 4 weeks (CMD 2400mg) over four 12-week treatment cycles (ie, Weeks 0, 2, 12, 14, 24, 26, 36, and38); and placebo (PBO) infusions delivered QOW for a total of 4 weeks over four 12-week treatment cycles (ie, Weeks 1, 3, 13, 15, 25, 27, 37, and 39) PBO infusions delivered QW for a total of 4 weeks over four 12-week treatment cycles (ie, Weeks 0, 1, 2, 3, 12, 13, 14, 15, 24, 25, 26, 27, 36, 37, 38, and 39) The primary objective of the study is to confirm the clinical efficacy of epratuzumab in the treatment of subjects with moderate to severe general SLE despite standard of care treatments (ie, corticosteroids, and potentially antimalarials and immunosuppressants) continued from Baseline. The secondary objectives of the study are to assess the safety, tolerability, and immunogenicity of epratuzumab, and to assess the steroid-sparing effects of epratuzumab treatment. The exploratory objectives of the study are to assess the pharmacokinetics (PK) of epratuzumab; the effects of epratuzumab treatment on individual components of the combined response index, fatigue associated with moderate to severe SLE, and the health-related quality of life (HRQoL) and utility benefits of epratuzumab treatment.

The Sydney Multisite Intervention of Laughterbosses and ElderClowns (SMILE) is a trial of humour therapy in aged care. The study will recruit 36 hostels and nursing homes, and half of these faciilties will be randomly assigned to receive humour therapy (intervention) or usual care (control). The intevention comprises ElderClowns visiting residents on a weekly basis, and volunteer staff in to be trained as LaughterBosses to bring humour into dialy care routines. About 400 residents will be assessed at three timepoints during the trial to test the hypotheis that humour may improve quality of life, engagement, and mood (e.g. depression).

Atypical hemolytic-uremic syndrome is a serious, life-threatening rare and chronic disease believed to be caused by genetic mutations. Current treatment for the disease is inadequate. Due to the uncontrolled complement activation seen in aHUS patients and the previously shown activity of eculizumab to selectively inhibit terminal complement activation, it has been decided to look in to the use of eculizumab in the treatment of severely affected aHUS patients.