ANZCTR search results

The aim of this study is to assess the feasibility and safety of an individually-tailored exercise and dietary program for women with metastatic breast cancer (MBC) and provide preliminary evidence on changes in patient-relevant outcomes such as quality of life. Who is it for? You may be eligible to join this study if you are a woman aged 18 years or over and have a diagnosis of metastatic breast cancer in the previous 5 years, or progression of metastatic disease over the last 2 years. Study details All women will receive a 16-week exercise and dietary program, individually-tailored based on their baseline assessment, tumour burden and treatment. The program will focus on increasing exercise (aerobic- and resistance-based), improving diet quality and managing nutritional symptoms (e.g., nausea/vomiting, constipation/diarrhoea), to improve (or attenuate declines in) quality of life, lean body mass and physical function. Data will be collected at baseline (T1/pre-intervention), 16-weeks (T2/end-of-intervention) and 10-months (T3/six-months post-intervention). We hypothesise that a 16-week exercise and dietary program will be feasible and safe for women with MBC and will improve (or reduce declines in) patient-relevant outcomes.

This is a prospective, randomised controlled trial comparing SNAP dressings, a type of negative-pressure wound therapy dressing, with standard wound dressings for patients aged 12-40 years undergoing an excision of a pilonidal sinus. Eligible patients (and for paediatric patients, their parents/guardians) will be approached for enrolment. Participants will then be randomised to have a SNAP dressing or standard wound dressing placed on the surgical wound after the pilonidal sinus has been excised and the wound primarily closed. Post-operatively, patients will be followed up on days 3, 7, 10 and 14 and then weekly in the Outpatients Clinic until the wound has healed to examine the wound. Follow-up will be conducted by a clinical nurse specialist or other member of the treating team. There will also be a follow-up 2 months and 6 months post-operatively. The study and patient follow-up will be assessing: 1. Rate of wound dehiscence (breakdown) in each group and assessment of progression of wound dehiscence using clinical photographs as evaluated by a blinded outcome assessor (clinical photographs only taken for wounds where a dehiscence has occurred) 2. Time taken for the wound to fully heal 3. Rate of disease recurrence within 6 months post-operatively 4. Analgesia requirements for the wound 5. Ratio of wound size two weeks post-operatively compared to at the time of surgery 6. Patient satisfaction with the dressing and wound healing and quality of life survey 2 months post-operatively 7. Patient phone/email questionnaire regarding disease recurrence and progress 6 months post-operatively 8. Time taken to resume normal activities For patients randomised to have a standard dressing (i.e. no SNAP dressing) who have a wound dehiscence, the endpoint for this trial would have met. For these patients, some will receive a SNAP dressing as determined by the treating team for further management of the dehisced wound. We will compare wound healing and assess outcomes in these patients with patients who go on to have further management with a standard dressing. This study will thus be aiming to establish whether the use of a negative wound pressure therapy dressing (SNAP dressing) improves wound healing, the rate of wound dehiscence, recurrence rates and patients’ quality of life and return to normal activities compared to a standard wound dressing.

Ten subjects with SCI already involved in an activity-based exercise/rehabilitation program visited the Neuromuscular Physiology laboratory at Edith Cowan University on three occasions at the same time of day separated at least by 72 h. The experimental conditions were only be two in this Study 2. The first session was a familiarisation session and the following two were experimental sessions with conditions completed in a randomised order. The aim of this study was to replicate the most efficient NMES protocol found in Study 1 in healthy population to provide the greatest total impulse and lowest fatigue rate, imposed both with and without simultaneous tendon vibration, to investigate acute effects in people with SCI. Electrical stimulation protocol Participants sat on a test chair and will be given twitches of electrical stimulation of the thigh muscle while their leg was held stationary by a testing machine (isokinetic dynamometer). Two passive electrodes were placed on the skin over their stronger thigh muscle (quadriceps) and they were given one of the electrical stimulation protocols. All of these procedures were safe, and are commonly performed at Edith Cowan University. The purpose of the present study was to determine whether patellar tendon vibration superimposed onto wide-pulse width NMES under standard clinical conditions elicits a greater peak muscle force with less muscle fatigue (i.e. a greater total impulse) when compared to NMES applied without patellar tendon vibration in people with SCI. We hypothesised that patellar tendon vibration superimposed onto wide-pulse width NMES would elicit a greater peak muscle force with less muscle fatigue (i.e. a greater total impulse) that NMES applied without patellar tendon vibration in people with SCI.

The coronary slow flow phenomenon (CSFP) is a coronary microvascular disorder that was first clinically characterised by University of Adelaide researchers. It is defined using a coronary angiography, a x- ray like procedure where a dye is injected into the heart arteries to investigate the patency of arteries, by delayed dye opacification of the large heart arteries, reflecting the underlying increased microvascular (small arteries) resistance. Studies conducted both at the University and at other sites, have implicated Endothelin-1 (a potent microvascular vasoconstrictor) could explain the CSFP. Basing on the existing evidence, present study investigates, Zibotentan, a potent endothelin-1 receptor blocker, benefits the CSFP patients by reducing angina frequency using a randomized, double-blind, placebo-controlled, cross-over trial design.

Title: A double blind randomised controlled trial assessing the effect of oral ibuprofen on outcome of flexor tendon repairs Short Title: Ibuprofen Flexor Tendon Trial (IFTT) Design: Double Blind Randomised Controlled Trial Hospital/s: Gold Coast Hospital and Health Service Study Question: Does oral ibuprofen influence outcome in patients post flexor tendon repair? Primary purpose of the study: This study has been designed to assess the effect of using oral ibuprofen after repair of hand flexor tendons on function and final outcome of hand . Study hypothesis is that use of oral ibuprofen after flexor tendon repair will result in improved outcome in comparison to when ibuprofen is not given.Ibuprofen should also result in decreased swelling of fingers. Many work hours will be saved and quality of life will be improved in flexor tendon repair patients if the study hypothesis is found to be true and a cheap and easily available drug like ibuprofen can reduce financial burden of these injuries on society and community. Study Objectives: Primary Objectives: Assessment of the effect of oral ibuprofen on outcome of flexor tendon repairs in humans: 1) Range of motion assessment using Strickland criteria 2) Range of motion assessment using ASSH criteria 3) Grip strength assessment 4) Michigan Hand Outcomes Questionnaire for evaluation of hand outcome Secondary Objectives: 1) Assessment of finger circumference 2)Assessment for delayed wound healing 3) Assessment for rupture of tendons 4) Assessment of need for tenolysis or follow up surgeries. Inclusion Criteria: 18 years of age and above Exclusion Criteria: Contraindication to NSAIDs/ibuprofen, systemic conditions/diseases like cardiac, renal, CNS, GI and others, documented allergy to NSAIDs Number of Planned Subjects: 66 Investigational product: Oral Ibuprofen Safety considerations: Coexisting cardiovascular, gastrointestinal and renal diseases; certain drugs Statistical Methods: Two arm trial- interventional and control. Two-sample t-test for a type 1 error (alpha) of 0.05 and a power of 90% for sample size calculation.

Background: Muscle force production is usually impaired in people with spinal cord injury (SCI). However, the use of high-intensity NMES strength training can help promote metabolically active lean muscle mass and thus, increase muscle mass and provide physical health and quality of life (QoL) benefits. Nonetheless, NMES is usually used at low-stimulation intensities (e.g. functional electrical stimulation) and there is limited evidence regarding the effects of high-intensity NMES strength training for increasing muscle force capacity and mass, ameliorating symptoms of spasticity or improving physical health markers and quality of life (QoL) in people with SCI. The primary purpose of this study was to investigate the effects of electrical stimulation of the thigh muscles using pads into improving the muscle size, muscle force, physical health, symptoms of spasms in the muscles and well-being in people who suffered from an accident and their legs are paralysed. The study hypotheses was that 12-weeks of electrical stimulation used as a muscle strength tool will improve muscle mass, muscle size, physical health, symptoms of spasms in the muscles and well-being in people who suffered from an accident and their legs are paralysed. Methods: Five individuals with SCI completed five 10-repetition sets of high-intensity isometric knee extension NMES strength training sessions for 12 weeks in both right (R) and left (L) quadriceps muscles. Quadriceps femoris isometric knee extensor torque was measured on a dynamometer and cross-sectional area (CSA- quadriceps femoris (QF)) were measured with extended-field-of-view ultrasonography. Venous blood samples were collected for blood lipid profiling and c-reactive protein (CRP) analyses. The Spinal Cord Injury Spasticity Evaluation Tool (SCI-SET) was used to assess symptoms of spasticity and the quality of life index (QLI) SCI version III was used for QoL measures.

People in hospital with broken ribs can experience a lot of chest pain which makes it hard to take a deep breath, cough and move around. The treatment of broken ribs includes various types of pain relief and physiotherapy to improve breathing ability and help you get up and moving. However, people with broken ribs may still have pain despite this treatment. We are doing a study to see if kinesiotaping is helpful for people with broken ribs. Kinesiotape is an elastic, adhesive, cotton-based tape that is applied to the skin. Its elastic properties mean it can be stretched over the involved area to support the tissues underneath. Kinesiotape is most often used for sporting injuries (e.g. knee, shoulder), but little research has been done about its effectiveness for people with broken ribs. While our usual practice at the Royal Adelaide Hospital has been to not use any type of taping after broken ribs, we are interested in doing a study to look at the effectiveness of kinesiotaping for people with broken ribs. This is an introductory study and if we find that kinesiotaping is beneficial and has no side effects we may consider doing a larger study in the future. The Royal Adelaide Hospital admits approximately 100 patients per year with rib fractures. Given our relative inexperience with kinesiotaping and the heterogeneity of this patient group we do not believe a randomised controlled trial would be a practicable study design in the first instance. Instead, this introductory study will comprise a series of 5 single-subject studies using an ABAB design. Depending on the ease of recruitment, sensitivity of the outcome measures and the results, a randomised controlled trial may be considered in the future. Two of the investigators will screen all in-patients admitted with rib fractures regarding their eligibility to participate. This screening is already part of physiotherapy routine clinical practice. For pragmatic reasons concerning the availability of the investigators and ability to follow-up with taping interventions and outcome measurements over the 4-day study period, patients will only be recruited on Mondays and Tuesdays. Any decision to exclude an otherwise eligible person will be reviewed by one of the other study investigators to minimise the potential for selection bias. When a potential participant is identified, one of the investigators will approach the person regarding participation from 0800 on that day. A written information form that explains the aims and format of the study will be supplied. Informed consent will be obtained from those willing to participate. If the patient agrees to participate, the study period will commence later that same morning. Apart from the application of taping, no other aspect of medical, nursing or allied health management will be changed.

This project constitutes the pilot study of a direct-to-brain Bionic Eye. In this study, up to 3 blind participants will have four small devices placed over the area of the brain responsible for vision. This area is called the visual cortex, which is located at the back of the brain. Each device contains an array of microelectrodes (which are like tiny wires as thin as strands of hair) and electronic circuitry that is capable of delivering small electrical pulses to the brain via the microelectrodes. The devices are powered and controlled wirelessly, so no wires need to be implanted. When the visual cortex is electrically stimulated, small points of light are seen by the participant, which can be assembled into basic images after adequate training. This study aims to teach blind participants to ‘see’ using these basic images, thereby demonstrating the safety and utility of the direct-to-brain Bionic Eye.

Stelis Biopharma has developed a biosimilar formulation of Teriparatide which has been proven to be qualitatively comparable with approved product Forsteo® (EU) and Forteo® (US) being marketed by Eli Lilly through several analytical methods. This Phase-1 study is designed to compare the pharmacokinetics, safety, tolerability, and pharmacodynamics of the biosimilar formulation developed by Stelis Biopharma with the reference formulation Forsteo® (EU) and Forteo® (US) being marketed by Eli Lilly and establish it's clinical comparability.

This trial aims to determine the ability of the PEPtrac to record airway clearance sessions performed at home by adults with cystic fibrosis utilising commonly used positive pressure airway clearance devices when compared to participant self-reports. Participants will use the PEPtrac and an airway clearance device for a one week period, performing a treatment session at least once daily At the completion of each treatment session, participants will complete a treatment diary entry. After one week, participants will also complete a questionnaire examining their experience of using the PEPtrac and any suggested design modifications that they may have.