ANZCTR search results

We aim to determine whether the use of a patient information video prior to the maternal anaesthetic preadmission interview affects the patient’s satisfaction with the information provided by the anaesthetist and if it affects their anxiety levels, directly after the interview. We will also measure the duration of the interview. Post-operatively, we will assess whether or not the use of the video affects maternal satisfaction with the entire “anaesthetic for caesarean section” experience. Video-based patient information supplementing clinician interview has been shown to reduce anxiety scores and increase patient satisfaction, for patients undergoing coronary angiography. Patient satisfaction with anaesthesia has been shown to correlate most with information given pre-operatively, involvement in decision-making and contact with the anaesthetist. No studies have examined the use of video-based patient information for patients undergoing caesarean section. The results of this research will provide information on how to improve maternal satisfaction and reduce anxiety in the perioperative period. Implementation of video-based information in the preadmission clinic may improve clinic efficiency while improving the patient experience.

This is a randomized, open-label, active-controlled study whose primary objective is to evaluate the safety and efficacy of several doses of GS-7340. This study will evaluate the safety, viral kinetics, and antiviral activity of each of four doses of GS-7340 over 28 days of therapy. In addition, the study will evaluate the antiviral activity of an optimal dose of GS-7340 versus TDF 300-mg over 28 days of therapy. Approximately 50 eligible subjects with chronic HBV infection who are naïve to anti-HBV treatment will be randomized 1:1:1:1:1 to receive treatment with GS-7340 8-, 25-, 40-, or 120-mg or TDF 300-mg orally once daily. Subjects may be HBeAg+ or HBeAg-. Enrollment will be stratified by HBeAg status with approximately a 1:1 distribution resulting in approximately 25 HBeAg+ and 25 HBeAg- subjects. All subjects must be followed for safety for 30 days after the 28-day treatment. Optional blood samples may be obtained for exploratory biomarker and pharmacogenomic discovery research at any time during the study or at a separate post study visit, if necessary. Subjects who agree to have blood drawn for pharmacogenomic research will sign a separate informed consent form.

This is a phase 1 study utilizing two fixed dose formulations of ELAPR and a control, by multiple intradermal injections to a 3cm x 3cm area of the upper arm dermis. Healthy subjects will be recruited to the study. Following a screening period of up to 28 days, subjects who meet the entry requirements will be enrolled to one of two Cohorts, Cohort A or B and randomly assigned to receive treatment with one of two ELAPR formulations plus the control. All subjects will receive three treatments, 3 weeks apart.Subjects will attend the Woolcock Institute of Medical Research, Clinical Research Operations (WIMR) for all procedures. On Day 1, 22 and 43 all subjects will have the intradermal injections at WIMR. Subjects will then have safety observations for 60 minutes. Photography of injected sites will be performed before and 60 minutes following intradermal injections. Subjects will return to the WIMR on Day 8, 29 and 50, for evaluation. Each treatment will consist of 21 injections in total, each 5mm apart in a grid formation over a 3cm x 3cm area of the mid - to deep dermis of the medial aspect of the upper arm. Each injection will consist of approximately 20ul of product delivered using a 30Gx1/4 inch needle. On Day 1, following the intradermal injections a needle point tattoo will be applied to the center of the implant site. The tattoo mark will assist in locating the implant sites and will be removed with the biopsy at Day 169 for cohort A and Day 85 for cohort B. Each subject will also receive Restylane (Registered Trademark) Vital Light (control) to the opposite arm following the same treatment regimen and using the same technique. A 4mm skin biopsy will be taken from each of the implant sites from Cohort A subjects (including replacements) on Day 169, and from Cohort B subjects (including replacements) on Day 85. The biopsy will encompass the needle point tattoo at the centre of the implant site. The biopsy site will be closed with a single stitch followed by standard aftercare procedures with stitch removal 7 to 10 days later. At each visit, subjects will be asked questions related to the status of implants, skin site texture and elasticity, skin reactions and any activities undertaken which may impact on the implant. The physical presence of the implants will be assessed by the investigator at each visit by palpation. Measurements of skin elasticity and skin thickness will be made using a Dermal Torque Meter (DTM) and skin calipers, respectively.

This is a Phase II clinical trial for the study of the efficacy of antimalarial drugs against Plasmodium falciparum by experimental challenge with a low dose of blood stage parasites in healthy male volunteers. This trial is to be conducted under the Australian Therapeutic Goods Administration (TGA) Clinical Trial Notification Scheme (CTN). The purpose of the study is to compare the gene expression profiles of whole blood and T cell subsets before and after experimental challenge with a low dose of Plasmodium falciparum blood stage parasites; To identify molecular signatures that predict disease outcome, as well as the safety and efficacy of future malaria vaccines and to investigate gametocyte maturation during early blood stage infection.

The aim of this study is to investigate if the treatment of rheumatoid arthritis (RA) based on the results of analysis of a biopsy of the involved joint lining is better than usual therapy (not based on the results of biopsy). The way standard care or bDMARD therapy will be chosen will be by the process called randomization (which will happen only once at the beginning of the study), which essentially is the equivalent of tossing a coin and deciding the treatment option on the basis of the result. This gives equal chance of going to either the bDMARD or standard care treatment arm. Once the patient has chosen to participate, they will receive an arthroscopic biopsy from the lining of an inflamed joint (called the synovium). The bDMARD will be chosen on the basis of the biopsy.

The aim of this study is to determine if an anaesthetic product applied as a gel onto a surgical field does absorb into the blood stream and, if so, to what extent. It is important to have this information because anaesthetic products can become toxic at a certain concentration. Twelve women who will undergo surgery at the Royal Hospital for Women (RHW) will be recruited for this study. Six among them will have laparoscopic surgery involving the abdominal wall and the pelvic organs; the other six will have surgery involving the uterus. Women will be approached at the public clinics of the RHW. Women will be given written and verbal information regarding the study at least a week prior to undergoing the surgery. The consented subjects will have the anaesthetic gel applied to the surgical wounds at the end of their procedure. Blood samples will be taken once before and ten times after the application of gel. The timing of the sampling will be spread over a period of 24 hours. All samples will be kept in a freezer until the end of the study and sent to a specialised laboratory for measurement of the concentration of anaesthetic product in the blood. The subjects will be monitored with regard to blood pressure, pulse and other vital signs as per normal hospital protocol and discharged from the study 24hours after their surgery.

The two hallmark neuropathological features of Alzheimer's disease are extracellular amyloid deposits, and intracellular deposits of neurofibrilliary tangles comprised of abnormal tau protein. The clinical trial of amyloid therapies have been disappointing and this clinical trial represents the first trial of a therapy directed towards tau pathology in Australia to our knowledge. Everyone has a naturally occurring protein called tau in the brain and the fluid around their brain and spine (cerebrospinal fluid). There is a link between Alzheimer’s Disease and a reaction involving tau where too much phosphate is attached. This may cause brain cells to work less well or die. Further, protein phosphatase 2A (PP2A) which breaks down phosphate has been shown to be less active in people with Alzheimer’s. VEL015 works by increasing the activity of PP2A and therefore decreasing the available phosphate in the brain. Studies in animals have shown that VEL015 helps to prevent this reaction between tau and phosphate. We now want to find out if it will help to treat Alzheimer’s Disease in humans.

The purpose of the study is to assess the efficacy of an oral antibiotic (Azithromycin) and an inhaled mucus-clearance agent (nebulised salt water, known as hypertonic saline) in people with bronchiectasis that is not due to cystic fibrosis. The interventions will be administered over a 6-month period. The investigators hypothesise that each intervention will improve the quality of life of people with bronchiectasis by reducing the severity of the chronic lung infection.

The proposed study investigates the physiology of brown fat in adult humans. Brown fat plays a major role in metabolism, protecting animals from obesity. In humans, brown fat is thought to disappear after infancy. However, metabolic imaging by positron emission tomography (PET)-CT using fluorodeoxyglucose (FDG), a glucose analogue, has revealed fat of high metabolic activity in the neck region in adults, confirmed to be brown fat on histology. Our previous molecular and histological analysis suggests brown fat to be present in the majority of adult humans. However, factors regulating brown fat activity/abundance are unknown. By PET, brown fat prevalence was higher in women, associated with lower age, weight and glucose level, suggesting regulation by hormones and a role in energy homeostasis. The hypothesis of the current study is that brown fat is regulated hormonally and contributes significantly to metabolism. We aim to determine physiologic factors which regulate brown fat activity and its metabolic significance in adulthood. The proposal involves regulatory studies in-vivo (FDG uptake) to explore effects of adrenergic, sex and metabolic hormones on brown fat activity. Metabolic significance will be determined by relating FDG uptake to diet-induced thermogenesis.

The purpose of this study was to 1) To revise and translate an integrated Cardiac-Diabetes Self-Management Program (CDSMP) incorporating telephone and text-messaging into Chinese. 2) To evaluate the effectiveness of CDSMP for patients with type 2 diabetes who have suffered a critical cardiac event among Australian and Taiwanese populations.