ANZCTR search results

This study is to find if one type of expander (a plate) is better at widening the upper jaw of children aged 10-16. The expander will be placed on their top teeth and will be one of the following: 1) Hyrax Expander: this is the common type of expander which requires a separate key to turn. 2) Hybrid-Hyrax Expander: this is the normal expander but it also includes two pins placed in the top of the upper jaw (palate) 3) Keles Expander: this is a new type of expander which has a built-in key to turn the expander. This new type of expander is not yet approved by Therapeutic Goods Administration. Our hypothesis is that the Keles expander will work as equally as effectively as the Hyrax, whereas the Hybrid-Hyrax will be more effective in expanding the jaw due to the use of the two palatal pins. Patients will be recruited at the Sydney Dental Hospital and will be included if they meet the inclusion criteria of having a narrow jaw and in the correct age range. Exclusion criteria include if patients have had previous orthodontic treatment and/or any serious health issues that may impact orthodontic treatment. 60 selected patients will be randomly placed into 3 groups of 20 patients each. Records of patients will be taken before treatment. The appliance will be constructed and installed on each patient. Patients will be taught to turn the expander and will continue expanding until the correct amount of expansion has been achieved. After this, the expander will be locked to prevent further turning and the patient left with the expander in-situ for 6 months to retain the changes in the expanded jaw. The expander is then removed and then new records taking. Patients are then followed up to continue with normal braces treatment as per normal. The records taken of participants will include: questionaires, photos, study casts, 3d photos, and Cone Beam CT images. The data retrieved from these records will be used to assess the dental, skeletal, facial and airyway changes as a result of the expansion. The primary outcome will be to assess the change in angulation of upper first molars relatve to the palate in cross section on Cone Beam CT images. Secondary outcomes include: easability of the difference appliances, airway changes, facial changes and skeletal changes measured on CT images..

The overall objective of this study is to pilot test the feasibility of a community and consumer engagement strategy using design thinking and EBCD methodologies in the healthcare setting. This study aims to invite consumers, carers, healthcare workers and/or visitors to the hospital to attend collaborative workshops and/or the InstaBooth (an interactive booth) to share their experiences and suggestions for improving hand hygiene practices and/or reducing hospital-acquired infections and inform the design of possible solutions to these healthcare problems. After data analysis is completed, one of the possible solutions designed in the collaborative workshops will be implemented at the study site and its impact will be evaluated.

Individuals with a spinal cord injury do not participate in sufficient physical activity to meet the recommended guidelines for good health. To promote physical activity, physical activity interventions are needed. The aim of this study is to evaluate the efficacy of a physical activity promotion intervention for community-dwelling adults with a spinal cord injury who use a wheelchair as their primary means of locomotion. The aim of the intervention is increase physical activity participation. Primary outcomes of this study will be increased amount of physical activity that the participants are conducting during their daily living. The secondary outcomes will be self-efficacy, social support and decisional balance in physical activity and health-related quality of life. The study design will be based on the single-subject research design guidelines for determining sample size and protocol for sampling behaviour (Romeiser Logan, Hickman et al. 2008). Each participant will participate in the study for a total of 40 weeks. The study will be conducted in the home and community environment of the participant. During the 40-week study, participant will be asked to wear two physical activity monitors: the wheelchair mounted device (Wheeleri) and a wrist worn accelerometer which has the look and feel of a wristwatch (ActiGraph GT9X). Participants will also be asked to complete four questionnaires measuring mediators of physical activity participation (including self-efficacy, social support and decisional balance) and measures of health related quality of life. The study protocol comprises 3 phases: baseline phase (8 weeks); intervention phase (16 weeks); and post intervention phase (16 weeks). During the 8-week baseline phase, participant’s physical activity will be monitored while they continue with their normal behaviour in order to determine their baseline level of physical activity. The baseline phase will be followed by a 16-week intervention. The intervention combines a stage-matched lifestyle physical activity intervention, structured exercise prescription and community integration delivered utilising a community-based rehabilitation. During the 16-week intervention period, participants will receive 12 face to face visits of a one hour duration in their own home or local community. In between these sessions they will also receive phone/online support as required (Dunn, Andersen et al. 1998). Session frequency will diminish over the 16-week period, with a reduced number of sessions as a result of an increased emphasis on maintenance of physical activity participation including fostering independence and self-management. The intervention phase will be followed by a 16-week non-contact post intervention period during which physical activity will be monitored in order to determine the extent to which any increases in physically active behaviour achieved during the intervention are maintained.

In the event of a “can’t intubate, can’t oxygenate” (CICO) event during general anaesthesia, front of neck access (FONA) is definitive management. Faster FONA can reduce morbidity and mortality. Localisation of the cricothyroid membrane (CTM) is necessary for successful FONA. It ideally should be performed before induction in every patient, though in some time critical emergencies there is not the opportunity to do this in an elective fashion. Palpation of landmarks to localise the CTM has been shown to be very inaccurate, particularly in women and obese patients. Ultrasound has been shown to be very accurate, although slower. Ultrasound for procedural guidance has been shown to improve the rate of correct cricothyroidotomy device insertions with fewer complications. This study aims to show primarily if a new 2-level transverse airway ultrasonography technique to localise the CTM is quicker than a known 3-level technique. Accuracy of the technique will also be assessed and compared between the techniques. Scanning participants will be randomised to which technique they perform first, and both timing and accuracy observers will be blinded to which technique is performed.

The primary purpose of this trial is to evaluate the feasibility and acceptability of a pre-operative exercise program in people undergoing major pelvic cancer surgery. Who is it for? You may be eligible to enrol in this trial if you are aged 18-80 years and are scheduled to undergo major pelvic cancer surgery. Study details All participants enrolled in this trial will be randomly allocated (by chance) to receive either the exercise program or to receive usual care. Participants allocated to the exercise program will receive a supervised one hour one-on-one exercise session once per week for 2-6 weeks, occurring prior to surgery. They will also be asked to complete the hour-long exercise session at home four days per week in addition to 150 minutes of moderate exercise (walking, cycling, etc.) per week. Following surgery, participants will be asked for their opinion of the exercise program, and some additional tests and questionnaires will also be completed to assess physical activity, strength, complications and other outcomes following surgery. It is hoped that the findings from this trial will provide information on whether the pre-operative exercise program is feasible and acceptable to participants, as well as providing preliminary data on the efficacy of the program for improving health outcomes following major pelvic cancer surgery.

Footwear has the potential to influence balance in either a detrimental or beneficial manner, and is therefore an important consideration in relation to falls prevention. The objective of this study was to evaluate balance ability and gait patterns in older women while wearing prototype footwear and insoles designed to improve balance.

Purpose The purpose of this study is to describe the safety of treatment with the study drug (BTX 1503 5% Solution) with twice daily dosing in subjects with acne vulgaris. The study drug’s effect on acne vulgaris will be evaluated. Study participants Patients with acne vulgaris aged between 18 and 65 years, inclusive, will participate. Experimental Treatment The study will investigate 3mL of BTX 1503 5% Solution applied twice daily to the face for 28 days. The study consists of a screening visit (up to 14 days before receiving study treatment) and an enrolment visit initially. On Day 7, a call will be made to each participant to ensure that they continue with dosing per instructions. There is a visit on Day 14 during the 28 day dosing period. Participants will return to the clinic on Day 28 for safety assessments. There is a follow up visit on Day 35. The maximum study duration for any participant will be a total of up to 49 days; screening period (up to 14 days), 28 days of treatment, and 1 week of follow-up.

The purpose of this physiology study is to determine the mechanisms through which Abdominal Functional Electrical Stimulation (Abdominal FES) improves respiratory function. This will be achieved by measuring a range of respiratory outcome measures with 15 tetraplegic participants, both with and without Abdominal FES, and before and after four weeks of Abdominal FES training.

Aim The aim of this non-inferiority randomised controlled trial is to investigate a regional technique that is as efficacious in analgesia as paravertebral block (PVB) and thoracic epidural analgesia (TEA) for open thoracic surgery using postero-lateral thoracotomy incision, but less invasive and easier to perform. Hypothesis We hypothesise that Serratus Anterior Plane Block (SAPB) catheter provides non-inferior analgesia compared to surgically placed Paravertebral Block (sPVB) catheter in open postero-lateral thoracotomy, with the largest clinically acceptable difference of 150mcg fentanyl in first 24h post operatively. Specific objectives 1. To demonstrate that analgesic effects of SAPB catheter is not inferior to surgically placed PVB catheter in open postero-lateral thoracotomy 2. To demonstrate that SAPB is a minimally invasive, safe and easy to perform alternative to PVB Method This trial will be a single centre non-inferiority, pragmatic, randomised controlled trial (RCT) with 2 parallel groups and 1:1 allocation comparing efficacy of analgesia of SAPB catheters to sPVB catheters for elective open postero-lateral thoracotomy. Significance Open thoracotomy is one of the most painful surgical incisions. Effective analgesia is imperative to good postoperative outcomes but it is difficult to achieve. A multitude of regional techniques have been developed however no one technique is safe and efficacious for all patients. The two current gold standard of post thoracotomy analgesia, PVB and TEA, are associated with significant barriers including side effects, complications, contra-indications and technical challenges. SAPB is a relatively new but promising technique that in healthy volunteers and cadaveric models was able to achieve paraesthesia of the ipsilateral hemithorax with few side effects. However the clinical efficacy of SAPB is not well established. SAPB can potentially provide similar analgesia to PVB and TEA for thoracic surgery but with improved safety profile and easier learning curve; this would represent a significant advancement in post thoracotomy analgesia. Likely benefits An effective yet minimally invasive regional technique with few side effects will be a safer alternative to thoracic epidurals and paravertebrals for thoracic surgery. Furthermore it may be particularly useful in ambulatory surgery and as a rescue technique.

The primary purpose of this study is to evaluate whether the presence of circulating tumour DNA (ctDNA) in a patient's blood following surgery or chemotherapy for ovarian cancer, is associated with cancer recurrence. Who is it for? You may be eligible to enroll in this study if you are aged 18 or over and have stage I-IV curatively resected high grade serous, endometrioid and clear cell ovarian, fallopian tube or primary peritoneal cancer or ovarian carcinosarcoma for which you are scheduled to commence neoadjuvant or adjuvant chemotherapy. All patients enrolled in this study will have up to five blood samples collected over 6-8 months, followed by a clinical follow up every 3 months for 2 years following completion of chemotherapy. Your treating clinician may also decide to continue with further follow-up. It is hoped that the findings from this trial will demonstrate an association between ctDNA detection in the patients blood following surgery and chemotherapy, with ovarian cancer recurrence. This would allow real-time testing of the benefit of adjuvant chemotherapy by assessing ctDNA.