ANZCTR search results

The aim of this research is to determine if osteopathic manipulative treatment (OMT) along with cognitive behavioural therapy (CBT) provides a better management of depressive symptoms in peri-menopausal women when compared to CBT alone. Peri-menopause is the three years, or more, prior to menopause, which is the final menstrual period a women experiences. It is hypothesised peri-menopausal women who receive OMT as part of their managment of mild depression or depressed mood will demonstrate a greater improvement in their depressive symptoms than those peri-menopausal women who receive only counselling.

Participants will inhale a 4mL radioaerosol in two positions in random order throughout the nebulisation period of 20 minutes: 1. Upright sitting: or 2. Alternate Side Lying: (alternated between left and right at each minute) After each nebulisation a gamma camera will perform a 20-minute deposition scan incorporating a 2-minute transmission scan to outline the three-dimensional margin of the lung fields. This data will be reconstructed to determine the distribution of the deposited radioaerosol in the lungs. A 15% improvement in uniformity of deposition is the proposed minimum difference that would make further investigation of the alternate side lying strategy worthwhile in patient populations. Significance of project: In many patient populations (eg, cystic fibrosis, HIV and bronchiectasis), the pattern of deposition of inhaled medication is poor and non-uniform. Typically the upper lobes receive a reduced dose compared to the rest of the lung. The ability to deliver a drug more uniformly to the lung using a strategy of side lying may have a significant impact on treatment efficacy for people with lung disease. Data from healthy participants will aid interpretation of subsequent studies in patients.

Research question: To determine whether the timing of HS inhalation (before, during or after airway clearance physiotherapy) impacts the subjective efficacy, tolerability and overall satisfaction, or lung function parameters in adults with cystic fibrosis

Research question: To determine whether alternate side lying improves uniformity of deposition of an inhaled aerosol compared to upright sitting in participants with cystic fibrosis (CF). Methods: Inclusion criteria: greater than or equal to 18 years of age, confirmed CF, stable lung function. Participants will inhale a 4mL radioaerosol in two positions in random order throughout the nebulisation period of 20 minutes: 1. Upright sitting: or 2. Alternate Side Lying: (alternated between left and right at each minute) After each nebulisation a gamma camera will perform a 20 minute deposition scan incorporating a 2 minute transmission scan to outline the three-dimensional margin of the lung fields. This data will be reconstructed to determine the distribution of the deposited radioaerosol in the lungs. A 15% improvement in uniformity of deposition is the proposed minimum difference that would make the alternate side lying strategy worthwhile in CF patient populations. Significance of project: In many patient populations (for example, cystic fibrosis, HIV, asthma and bronchiectasis), the pattern of deposition of inhaled medication is poor and non-uniform. Typically the upper lobes receive a reduced dose compared to the rest of the lung. The ability to deliver a drug more uniformly to the lung using the simple strategy of side lying may have a significant impact on treatment efficacy, acceptability and compliance for people with lung disease.

The main purpose of this study is to ascertain whether inhaled oxytocin might have therapeutic potential in reducing the cognitive rigidity and social anxiety that have been shown to be important perpetuating factors in Anorexia Nervosa. Participants will be analysed to determine whether oxytocin brings about any improvements in thinking which might help patients with Anorexia Nervosa to recover more easily.

This study assesses the efficacy of microneedling in wound healing for patients with recessive dystrophic epidermolysis bullosa. Symmetrical wounds will be measured and randomised to either treatment (microneedling) or placebo (microneedling without needles)

When a cancer needs to be removed after a biopsy (and the surgeon cannot feel it) it is normally localised and marked for the surgeon by a radiologist who places a fine wire into the abnormality using ultrasound or x-ray guidance, sterile conditions and after using local anaesthetic (to numb the area). This “wire localization procedure” is done on the day of the operation and has been the standard treatment used at this hospital for over 20 years. A gentle mammogram picture is necessary to check the position of the wire. The surgeon uses the wire to guide them during the operation and the abnormality and the wire are removed whilst you are asleep. The localization procedure can be difficult and time consuming. Sometimes the wire can be difficult to put in, especially if the breast tissue is very firm. Occasionally the tip of the wire is not right next to the abnormality which means that another wire needs to be put in. The direction the Radiologist has to take to place the wire may not give the best approach for the surgeon and the incision may be some distance from the abnormality. Sometimes after the pathologist has looked at the removed tissue, it is found that the abnormality has not been completely removed, which means that a further operation is needed to make sure all the abnormal tissue has been removed. More recently surgeons overseas have been using an alternative way of marking small breast abnormalities using a low dose radioactive “seed” which contains Iodine 125. This is placed into or next to the abnormality either on the day before or the day of the surgery. The surgeon then uses a special hand held probe that can detect the signal given out by the seed to find the abnormal area within the breast. The probe makes a noise which becomes louder the closer it is to the abnormality and gives continuous feed back to the surgeon so that they can adjust their position and to help make sure as much of the abnormal area as possible is removed during the one operation. Studies suggest that with this technique the abnormality is more often completely removed without the need for a further operation and because it is easier for the surgeon to find the abnormality, the appearances of the breast after the operation may be better than if a wire localization of the lesion had been performed. The technique of inserting the radioactive seed and removing it is reported to be very easy with very few complications. Our surgeons are already trained in the technique of using the special hand held probe to find and remove lymph glands after the injection of a radioactive liquid and have been doing this for many years (sentinel lymph node removal). The use of the probe for detecting and removing the seed will be a similar technique. Our radiologists are also already very experienced in placing small metallic markers (similar to the seeds apart from being non radioactive) into the breast after biopsying small abnormalities. For the 20 participants in this study, we are planning to use the standard wire localization as well as placing a radioactive seed into the breast abnormality to enable us to gain experience with the new technique. The wire will be there as a backup to make sure your abnormality is removed We will review our results at the end of the study to see if we had any problems with the new technique that we need to improve on. If, as we anticipate there are no problems, we plan to start a large research trial to compare the results of surgery using the seeds compared with the wire to localize small breast cancers.

This study aims to assess the safety and efficacy of a drug called gabapentin for the treatment of acute pain syndrome associated with chemotherapy in women with breast cancer. Who is it for? You can join this study if you are a woman aged 18 years or more with early stage breast cancer for which you have had surgery. You must also plan to undergo chemotherapy treatment with the drug, docetaxel. Women who have pre-existing pain prior to chemotherapy will not be eligible. Trial details In this study, participants will be randomly (by chance) assigned to receive either the drug, gabapentin, or a placebo (sham) tablet during their second cycle of chemotherapy treatment. Gabapentin is a drug used to treat nerve pain. The dose of Gabapentin is 300mg three times a day, orally, starting the day before chemotherapy, for 6 days in total. On the third cycle of chemotherapy treatment, participants will be given the alternate treatment (i.e. gabapentin or placebo). Participants will not know whether they are taking the active or sham treatment. Participants will be asked to complete questionnaires rating their pain levels for a week after chemotherapy. They will also be monitored for safety. It is hoped that gabapentin will reduce the aches and pains in muscles and joints which are commonly experienced by women receiving the chemotherapy drug, docetaxel.

Objectives: To determine if the study protocol (PHARLAP – permissive hypercapnia, alveolar recruitment and low airway pressure) can be implemented safely and effectively at a centre where there is no previous experience with the trial in order to determine the feasibility of establishing this as a large multi-centre trial in Australia and New Zealand. We hypothesis that PHARLAP strategy can be safely implemented in any ICU in Australia and New Zealand. Proposed Methods: Study design: (control groups should receive best treatment currently available). There is no control group. The treatment group receives the PHARLAP treatment protocol and data is collected to determine the adherence to study protocol. The PHARLAP strategy includes pressure control ventilation (PCV, 15 cm H2O above PEEP) with patients in supine, 30 degrees head up. The fraction of inspired oxygen (FIO2) is reduced until oxygen saturation was 90-92%. For the SRM, the PEEP is increased in a stepwise manner to 20, then 30 and then 40 cm H2O every two minutes, and then reduced to 25, then 22.5, then 20, then 17.5 or then 15 cm H2O every three minutes until a decrease in SaO2 of 1% from maximum SaO2 is observed. This is defined as the derecruitment point. PEEP is then increased to 40 cm H2O for one minute and returned to a PEEP level 2.5 cm H2O above the de-recruitment point (defined as optimal PEEP). Following this SRM step the tidal volume is decreased to achieve a plateau pressure less than 30 cm H2O. Hypercapnia is tolerated and acidosis will only be treated if the pH is less than 7.15 by increasing respiratory rate to a maximum of 38 breaths per minute, or administration of sodium bicarbonate. The participants will receive one SRM daily (with decremental PEEP titration). In addition, PEEP will be transiently elevated to 40 cm H2O (with PCV at 15 cm H2O) for one minute if oxygen desaturation less than 90% occurred or after disconnection from the ventilator. The SRMs will be repeated once per day until the patient is ready for weaning. Patients are assessed daily for weaning. Weaning will be commenced when all of the following occurred: respiratory rate < 35 breaths per minute, PaO2 > 60 mm Hg, SpO2 > 90% with fraction of inspired oxygen < 0.4 and PEEP < 10 cm H2O, mean arterial pressure > 60 mm Hg without inotrope infusions or sedatives.

Background: Post-operative cystoid macular oedema (CMO) is a complication of uneventful cataract surgery. While improved surgical techniques have decreased the incidence of CMO, it remains a cause of unfavourable visual outcome following surgery. Fundus fluorescein angiography has been the ‘gold standard’ for diagnosing sub-clinical CMO, however non-invasive cross-sectional imaging of the retina with optical coherence tomography (OCT) may be equally effective at detecting the condition and offers the ability to quantify and repeat results over time. Design: Prospective pre-post case series of patients undergoing routine phacoemulsification surgery. Participants: Eighty consecutive patients (100 eyes) with cataracts and an age range of 40 to 90 years (M 76.18). Methods: Macular thickness of participants was determined using time-domain OCT pre-operatively and after surgery at 1 day, 1 week, 4 weeks and 6 months. OCT was used to diagnose post-operative CMO. Main outcome measures: Presence of cysts at the macula, identified by OCT, in addition to foveal and macular thickness (µm). Results: CMO was present in 5% of eyes. Macular thickness increased after surgery and central foveal thickness (CFT) increased by almost 7% but returned to pre-operative levels after 6 months. Findings also indicate that patients who developed post-operative CMO had significantly thicker CFT of approximately 5% compared with those that did not. Conclusions: OCT is a useful, non-invasive diagnostic tool in determining sub-clinical CMO in uncomplicated cataract surgery patients and detects the presence of retinal thickening and intra-retinal cysts very soon after surgery, thereby facilitating earlier diagnosis and treatment of post-operative CMO.