ANZCTR search results

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

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31346 results sorted by trial registration date.
  • A study on energy-burning effect of brown fat in humans

    Obesity is a major health issue worldwide. Despite global research efforts, effective treatments for obesity are limited. There are two kinds of fat in the body: white fat and brown fat. White fat functions mainly as an energy-storing organ and in excess results in obesity and complications such as diabetes and high blood pressure. Brown fat on the other hand releases the energy stored in fat as heat. It protects small animals and newborn human infants from cold temperatures. New imaging techniques have revealed brown fat to be present in significant amount in adult humans. Using special metabolic imaging, called PET scanning, brown fat is shown to be more abundant in lean individuals with lower blood glucose levels, suggesting that brown fat may regulate energy balance and metabolism. In animals, cold temperature and food both stimulate brown fat, resulting in release of energy. This is called adaptive thermogenesis, and it represents a considerable portion of total daily energy expenditure. Whether brown fat controls adaptive thermogenesis in humans is unclear. This is clinically relevant because if brown fat regulates adaptive thermogenesis in humans, strategies can be developed to stimulate brown fat to increase energy expenditure, which may be a new method to help attain weight control and develop treatment of obesity-related disorders. In order to determine the physiologic significance of brown fat activation, we designed a study investigating the effects of cold exposure and food on brown fat in humans. We hypothesize that adaptive thermogenesis in adult humans can be activated by cold or food, and the extent depends on individual brown fat abundance. Brown fat activity can be increased by cold stimulation, which could result in beneficial metabolic changes in the body. The aims of the current project are to: 1) determine relationship between brown fat and adaptive thermogenesis 2) investigate the underlying hormonal mechanisms and significance of brown fat activation Brown fat abundance will first be measured by PET scanning during mild cold condition. Volunteers then undergo metabolic and hormonal testing at standard ambient temperature (24 degrees). A parallel study will examine brown fat biopsies obtained during elective neck surgery to investigate mechanisms underlying brown fat activation. Significance: Based on its role in energy homeostasis and protection against obesity in animals, brown fat is likely to have a similar role in adult humans. Determining the contribution of brown fat to energy metabolism may lead to novel treatment strategies of obesity.

  • The safety and efficacy of combination treatment using adipose derived adult stem cells, platelet-rich-plasma and peptides on patients with Multiple Sclerosis.

    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 peptides, stem cells can also be stimulated to differentiate into a range of different cell types when transported to the site of degradation. This trial is investigating to what extent an injection of the Stromal Vascular Fraction obtained from the participants own fat tissue and Platelet-Rich-Plasma, and in combination with proprietary peptides reduces the progression of disease and improves quality of life. The peptides 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. This study involves patients with neuro-degenerative disease specifically, multiple sclerosis of all categories.

  • Standardised patient scenarios versus peer-role play to develop physiotherapy student safety skills in readiness for clinical placement: a pilot non-randomised controlled trial.

    Using simulated learning environments with standardised patients (SPs) provides a way to scaffold the development of skills for patient safety in a low risk environment. There are no data regarding whether adding SP interactions in early years of physiotherapy training improves safe performance on clinical placement. We aimed to assess the feasibility of recruiting and collecting data from junior physiotherapy students during an SP workshop with a pilot non-randomised trial, also assessing time, cost and scheduling information. Second year physiotherapy students were invited to participate and allocated to either the SP workshop in a simulated hospital environment (with and without video feedback) or usual teaching comprising peer role play. The main outcome measures were participant recruitment, retention and survey response rates, whether the training and workshops were delivered as scheduled and costs for SPs and staff training and workshop attendance. Students self-reported confidence, communication, preparedness for clinic and satisfaction was measured using pre-post surveys.

  • An effect of antenatal and postnatal maternal support programs on attachment and resilience for mums and infants: A Randomised Controlled Trial.

    Resilience is the capacity to rebound, and adjust from adverse experiences and maintain normal psychological and physical functioning, avoiding serious mental illness. Resilience can be built and fostered in an environment of protective factors. For infants the most important protective factor is having secure attachment relationships with their primary caregivers; generally their parents. However the parent-child attachment process is frequently disrupted when the parent/s have a mental illness as they may be less sensitive to the emotional cues of their children and less emotionally responsive. The purpose of this project is to test the effectiveness of two psychologically-based interventions which have been developed to help parents with mental illness or mental health concerns, become more responsive to their infant and foster a secure attachment relationship, thus building resilience in both parents and child.

  • A retrospective audit of the after-hours counselling service in an acute tertiary hospital.

    Since the inception of the after-hours social work service at the Royal Adelaide Hospital in 1999, social work staff providing this service have collected summary data on a per-patient basis. To date, these data have not been formally reviewed. The aim of this retrospective study is to transcribe the data from the hard copies into an Excel file to allow descriptive analysis of the types of patients referred, referral source, their location, the type of social work involvement, complexity of the case and its perceived importance. Additionally, data that have been collected regarding the impact of providing these after-hours services on the provider the following day will be collated. As well as analysing these data collectively, trends and changes over time will be reviewed.

  • Mesenchymal Stem Cells (MSC) for the amelioration of ischaemia-reperfusion injury (IRI) after deceased donor renal transplantation, a phase 1 pilot study

    In performing a renal transplant, the time spent by the graft outside the body and cooled on ice (non-perfused) is critical to its future functional capacity. With deceased donor transplants, this may be many hours and there is damage caused to the cells of the kidney by the lack of oxygenated bood suppy, which is called ischaemia. On connection of the donor renal atery to the intended recipients leg artery, blood flow is suddenly restored and the kidney is rewarmed or reperfused. Reperfusion itself is associated with further damage caused by the complex changes on blood vessels and immunological response following the period of ischaemia; the ischaemia-reperfusion injury (IRI). This may lead to delayed function of the kidney, during which the kidney undegoes repair. Changes associated with its recovery may include those that cause injury and scarring and lead to significantly worse renal function in the longer term, causing premature graft senescence and loss. There are currently few effective strategies to reduce this damaging response other than minimsation of cold ischaemia time. Many animal studies have shown that the infusion of mesenchymal stromal cells (MSC) to the recipient lessens the injury associated with IRI and allows earlier short term and better long term kidney function. We propose to use third party normal (non-immunogenic) MSC at the time of and 7 days following reperfusion of a cold stored kidney, in order to lessen this damage in a pilot study of 10 patients.

  • Imaging of Retinal Amyloid Plaques in Alzheimer’s disease - Middle aged Controls Study

    Alzheimer's Disease is characterised by the presence of beta-amyloid plaques in the brain. More recently, it has been proposed that these plaques may first appear in the retina, at the back of the eye before the plaques are detectable in the brain. Curcumin, found in the spice Tumeric, is a food additive that has molecular and optical properties that enhance the ability of the image amyloid plaques in the retina. Participants will be asked to have a eye imaging done before and after taking curcumin for 7 days. The presence/absence of plaques in the eye's retina will be correlated with the results obtained from participation in the AIBL study.

  • An evaluation of the Flinders Program to improve patient quality of life and self-management competencies in osteoarthritis and co-occurring obesity: A randomised controlled trial.

    Does the Flinders self-management support program improve HRQoL for obese osteoarthritis patients on a total knee or hip arthroplasty waiting list? Does the self-management support Flinders program help obese osteoarthritis patients on a total knee or hip arthroplasty waiting list to reduce their obesity? What demographic and psychosocial factors contribute to weight loss for obese osteoarthritis patients on a total knee or hip arthroplasty waiting list?

  • Study of the interaction between Complementary and Alternative Medicine and standard anti-cancer therapy in women with breast cancer

    Background. Although the use of complementary and alternative medicines is widespread in cancer patients, clinical evidence of their benefits is sparse. Furthermore, while they are often assumed to be safe with regards to concurrent use of anti-cancer therapies, few studies have been carried out to investigate possible interactions. Fucoidans are a group of sulfated carbohydrates, derived from marine brown algae, which have long been used as dietary supplements due to their reported medicinal properties, including anti-cancer activity. The aim of this study was to investigate the effect of co-administration of fucoidan, derived from Undaria pinnatifida, on the pharmacokinetics of two commonly used hormonal therapies, letrozole and tamoxifen, in patients with breast cancer. Methods. This was an open label non-crossover study in patients with active malignancy taking letrozole or tamoxifen (n = 10 for each group). Patients took oral fucoidan, given in the form of Maritech ('Registered Trademark') extract, for a three-week period (500mg twice daily). Trough plasma concentrations of letrozole, tamoxifen, 4-hydroxytamoxifen and endoxifen were measured using HPLC-CAD, at baseline and after concomitant administration with fucoidan. Results. No significant changes in steady-state plasma concentrations of letrozole, tamoxifen or tamoxifen metabolites were detected after co-administration with fucoidan. In addition, no adverse effects of fucoidan were reported and toxicity monitoring showed no significant differences in all parameters measured over the study period. Conclusions. Administration of Undaria pinnatifida fucoidan had no significant effect on the steady-state trough concentrations of letrozole or tamoxifen, and was well tolerated. These results suggest that fucoidan in the studied form and dosage could be taken concomitantly with letrozole and tamoxifen without the risk of clinically significant interactions.

  • SLEEP intervention for BACK Pain (SleepBack study): A randomized co-twin trial

    This feasibility study aims investigate the value of a sleep quality program in people with low back pain and insomnia. The specific aims of this study are to investigate: (1) the rate of recruitment of adult twins registered at the Australian Twin Registry (ATR) with LBP to participate in the trial, (2) the feasibility of data collection and outcome measure completion, (3) contamination of intervention among twins, (4) acceptability and experience of the intervention, and (5) the sample size required for the full trial.

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