ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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31380 results sorted by trial registration date.
  • Standardised assessment and management of frailty in elderly respiratory patients

    Frailty is a condition in elderly people where there is increased vulnerability to acute illness and poor recovery. Elderly people with long-term respiratory diseases such as COPD or asthma are more likely to be frail or to become frail as compared to elderly people without respiratory disease. Frailty can be screened for, and with appropriate management, the progression of frailty may be prevented, slowed, or even reversed. This study aims to demonstrate that screening and managing frailty in elderly respiratory patients will improve their health outcomes over 12 months.

  • Interactive training methods for the assessment and management of neck pain

    Exercise has been identified as an important element in the management of neck pain but it is not known which type is the most optimal. Virtual reality training might be of benefit. Various sensorimotor and kinematic impairments have been identified in patients with neck pain, and should be addressed in treatment. This research aims to investigate the effect of two types of exercise regimes on neck impairments. One regime will include balance, repositioning, eye and kinematic exercises tailored to the patients. The other exercise regime will include this as well as interactive VR training fascilitating cervical motor control and quick mobility in patients with neck pain.

  • Higher protein, lower carbohydrate diet to reduce glycated haemoglobin (HbA1c)

    The research project aims to show by offering a relatively flexible and straightforward dietary regimen low in carbohydrate (replaced with protein and/or unsaturated fat) to poorly controlled type 2 diabetes patients (HbA1c >7.5%), HbA1c will be significantly reduced over a period of 6 months in the absence of weight loss.

  • Role of Queen Garnet Plum in prevention of thrombotic (blood clotting) risk factors

    Queen Garnet Plum (QGP) is a result of a Queensland Government innovative breeding project. Agri-Science Queensland, a service of the Department of Agriculture, Forestry and Fisheries (DAFF) has shown QGP to have 5-10 times higher antioxidant levels compared to all other varieties of plums. We hypothesize that antioxidant rich QGP may lead to decreased platelet and clotting activity, reducing inflammation and improving lipid profile by influencing fat metabolism in normal healthy population as well as under increased oxidative stress conditions. The aims of the present double blind crossover interventional study are to compare and examine effectiveness of the 4 weeks supplementation of Queen Garnet Plum with commercial Bickford prune juice and a colour and sugar matched placebo on platelet and haemostatic function as well as inflammation markers and lipid profile in normal healthy population. We wish to prove our hypothesis that due to high antioxidant (anthocyanin) content these fruits may be instrumental in preventing cardiovascular disorders by attenuating platelet and haemostatic activity. For the first protocol of the study, 20 volunteers will be screened for recruitment to the study based on inclusion and exclusion criteria. Each participant will undertake 3 oral supplementation treatments for 4 weeks each with a washout period of two weeks between each treatment. A pre and post treatment fasting blood and urine sample will be collected to evaluate the efficacy of each treatment and comparison between placebo and two types of plums. Each blood sample will be tested for full blood examination, 3 different types of platelet function tests, coagulation profile, inflammation marker, lipid profile, uric acid and full blood + urine antioxidant levels with specific polyphenol quantitative screen. Second protocol will be similar to first protocol but with only 2 oral supplementation treatments of 4 weeks each with one 2 week washout period between them. The participants will be tested for VO2max by physician trained in exercise science prior to starting this protocol of the trial. A fasting blood and urine sample will be collected from each participant both pre and post induced oxidative stress by 45 min – 60 min exercise at 70% of maximal aerobic power (VO2max) before and after 4 weeks consumption of QGP and placebo. Testing protocol will be similar but including some specialised testing of platelet surface markers and thrombolytic pathways to examine the mechanistic pathways affected by the plum supplementation in reducing the thrombotic risk factors.

  • HiQCell TM Joint Registry in patients with osteoarthritis following the HiQCellTM procedure. (This is not a clinical trial - patients undergoing the treatment as prescribed by their specialist are followed up post-procedure.)

    This is an observational registry to assess the long-term safety and efficacy of the HiQCell procedure in patients who have been prescribed the procedure to treat joint arthritis following a registered medical specialist consultation.

  • A prospective study of orthodontic retention outcomes with different retention strategies

    Undesirable tooth movement following orthodontic treatment is common. Retention refers to the period of treatment after your braces have been removed and is required to help prevent teeth from moving back to their original positions. One method of retention is to use removable or fixed retainers (retainers are orthodontic devices that help to keep your teeth in the correct position and they can either be removable or be glued discreetly onto the teeth). The eruption of second and third molars is sometimes held responsible for unwanted tooth movement and many third molars (wisdom teeth) are removed as part of the orthodontic treatment plan (before treatment, as part of or after orthodontic treatment). The delay in removal of the third molars is not uncommon where the third molars are delayed in development. The aim of this study is to compare some regularly used retention regimes and the following will be tested; Whether there is a difference in outcomes between two commonly used maxillary, top teeth retainers, Whether there is a difference in outcomes of two commonly used mandibular, bottom teeth retainers;whether there is a difference between subjects who retain their third molars and those who have their third molars removed at the completion of treatment

  • A study of the effect of preoperative chemoradiotherapy on sexual dysfunction in men with locally advanced rectal cancer

    This study is designed to assess rate of sexual dysfunction in men following treatment with radiotherapy and surgery for rectal cancer. It aims to identify potential causes of sexual dysfunction in this group of patients, including assessing testicular hormone function following this treatment.

  • Treatment of Food Cravings: A Comparison of Emotional Freedom Techniques, Cognitive Behavioural Therapy and a Control Group

    Food cravings frequently lead to consumption of the craved food (Hill & Heaton-Brown, 1994), are positively correlated with BMI (Delahanty, Meigs, Hayden, Williamson, & Nathan, 2002; Franken & Muris, 2005) and obese adults report preferences for high fat foods (Drewnowski et al., 1985), therefore addressing these cravings in treatment is paramount. This study will examine treatment of food cravings in overweight or obese adults. Food craving is hypothesised to be an important intervening causal variable in the development of obesity. Research examining meridian-based procedures (e.g. Emotional Freedom Techniques, EFT) for food cravings has recently found significant improvements occurred in weight, body mass index, food cravings, subjective power of food, craving restraint and psychological coping for participants from pre- to 12-months after a 4-week treatment (p<0.05). This randomised clinical trial intends to extend this work and compare EFT treatment for food cravings, with a gold standard treatment strategy, Cognitive Behavioural Therapy (CBT), in addition to a control group.

  • Intravitreal Aflibercept for the treatment of previously treated exudative age-related macular degeneration

  • Efficacy of Oral Vitamin K to reverse chronic Warfarin Anticoagulation at 24 hours: A Phase 2 pharmacological Modelling Study.

    The peri-operative management of patients on long-term warfarin therapy is a common clinical problem which poses particular problems and uncertainties given the absence of clinical trials. Approximately 400,000 patients are assessed annually in North America for temporary interruption of warfarin therapy for elective surgical or invasive procedures. In Australia, this amounts to approximately 23,000 patients per year, and it is estimated that 700 such patients undergo surgical intervention annually at Southern Health. It is also likely that warfarin will remain the predominant form of anticoagulation for a long time despite the arrival of the novel anticoagulants. For many procedures, patients need to stop their warfarin to avoid bleeding at surgery and resume this postoperatively to prevent thrombosis. The literature does not define a standard of care so that there is considerable variability in how this is achieved with strategies ranging from cessation of warfarin 5 days prior, to “bridging” with heparin therapy when the INR falls below 2. The former approach is simpler but can expose high-risk patients to a significant risk of thrombosis whereas the latter requires timely coordination, and is resource intensive as well as costly. On the other hand, if warfarin is inadequately reversed many elective procedures might be cancelled at short notice inconveniencing patients and wasting valuable surgical operating times. Therefore, there is a need to identify a safe, simple, effective and readily available strategy to reverse warfarin across a broad spectrum of perioperative scenarios. Recently, Burbury et al (BJH 2011) demonstrated that 3 mg of intravenous (IV) Vitamin K (VK1) administered on the eve of surgery is effective and safe at reversing the anticoagulant effect warfarin in most patients. Furthermore, neither warfarin “resistance” nor thrombo-embolism was observed when warfarin was resumed postoperatively (0%, 95%CI: 0% to 2.6%). However, this approach requires the inconvenience of attending an outpatient clinic for insertion of an intravenous cannula for IV VK1 administration. Moreover, there is a small risk (3 in 10, 000) of allergic/anaphylactic reaction with the IV route. Although slower in its onset of action, a few studies have shown that given sufficient time, oral VK1 is as effective and safe in reversing warfarin as IV VK1. The oral dose represents a convenient and cheaper way of administration with minimal adverse reaction when compared to the IV formulation. Moreover, oral VK1 is a convenient way of administration with minimal adverse reaction compared to the IV route. This oral approach, if proven, would simplify pre-operative management of warfarin therapy, and has the potential to improve the care of thousands of patients in the perioperative setting. However, the optimal dose of VK1 that is required to reverse the INR of the majority (95%) of patients without causing warfarin resistance is uncertain. Firstly, we propose a prospective phase 2 dose finding study using pharmacological modeling and simulation to predict the effective dose for oral VK1 capable of reversing warfarin induced anticoagulation in a group of patients who are going to complete a defined period of anticoagulation therapy and therefore at minimal risk. Once an effective oral VK1 dose is identified, we plan to validate this dose in a prospective phase 3 clinical trial involving elective surgical patients.

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