ANZCTR search results

The purpose of this study is to compare subjective comfort, vision and satisfaction ratings, after insertion of mini-scleral (small diameter rigid gas permeable) contact lenses, when a drop of either ocular (eye) lubricant (i) Systane Complete containing HP-Guar and mineral oil (test eye drop #1) or (ii) Systane Hydration containing HP-Guar and sodium hyaluronate (test eye drop #2) is instilled prior to filling with unpreserved saline before inserting the lenses on eye, compared to filling with unpreserved saline alone (control eye drop), up to 6 hours after lens insertion. The hypothesis is that subjective ratings will be superior at any timepoint (2, 4 or 6 hours) post-lens insertion, when a drop of Systane Complete (test eye drop #1) and/or Systane Hydration (test eye drop #2) is instilled in mini-scleral contact lenses prior to filling with unpreserved saline, compared to filling with unpreserved saline (control) alone.

Iron deficiency anaemia is a common condition that frequently requires intravenous treatment in patients with chronic conditions. Two formulations of intravenous iron are available in Australia that are used for total body iron replacement. However, the newer ferric carboxymaltose is limited by high cost and a maximum dose of 1000 mg per week over 15 minutes. Iron polymaltose has the advantage of being cost-effective with the ability to provide total body iron replacement in one administration of up to 1500 mg over 1 hour or greater amounts over 4 hours. A pilot study in 2017-2018 demonstrated safety of delivering iron polymaltose at doses up to and including 1500 mg over 30 and 15 minutes. This will be an open-label, single centre study aiming to confirm the safety of iron polymaltose administered as an ultrarapid (15-minute) infusion in a general hospital population. Patients diagnosed with iron deficiency anaemia of any cause requiring replacement with iron polymaltose doses up to 1500 mg will be enrolled into the study after obtaining consent. Rates and severity of adverse events will be compared to those previously published for iron polymaltose administered over 1 hour and 4 hours, as well as to previously published safety outcomes for ferric carboxymaltose infusions.

The aim of the proposed study, 'Minimising Immunisatin Pain in Younger Children (MIPY) is to evaluate the efficacy of two novel devices, Coolsense® (cools and numbs the skin) and Buzzy® (vibration) with cooling pads (wings) versus standard care, and to minimise pain during immunisations in younger (aged 3.5 - 9 years inclusive) children (MIPY). Outcome measures will include 1. Child/adolescent self report of pain using the Wong Baker Faces pain rating scale, 2. Parent assessment of their child's fear/anxiety using the Child Fear Scale (CFS) (Pre and post procedure), 3. Nurse assessment of child's fear/anxiety using the CFS scale (Pre and post procedure) 4. Nurse report of observed pain using the VAS Scale, 5. Parent perception of usefulness of Intervention and Nurse observed compliance with intervention. We estimate it will take up to 6 months to recruit the required number of children for these studies based on 75% uptake of those that meet the inclusion criteria. The study groups will be assigned randomly by a computer. It is hoped 492 children will participate in this study, with 164 participants in each group. Before each child has their vaccine, we will either apply Buzzy® (with the cooling pad) or the Coolsense®device, or use the standard distraction method (blowing bubbles). Possible outcomes will be reduced pain and fear/anxiety scores and improved patient and family experience of vaccination.

This study will test the efficacy of topically applied rHDL to acute wounds of patients that have just had a ray amputation (removal of toe(s)) due to diabetes-related necrosis. They will receive rHDL three times a week for 6 weeks. Follow up will be for a total of 12 months.

A phase II multicentre single arm study of patients with type I diabetes who receive a pancreatic islet transplant for hypoglycaemia unawareness. Patients will receive Thymoglobulin induction with belatacept and sirolimus without corticosteroids. Outcomes will be compared to historical controls receiving our standard immunosuppressive protocol of, ATG induction, tacrolimus and mycophenolate mofetil. In addition patient outcomes will be compared to data with islet registry outcome data from the Collaborative Islet Transplant Registry (CITR).

Humidified incubators are currently widely used in the care of premature infants to assist with thermal stability however, hypothermia continues to be a problem, as optimal thermal weaning practices remain unclear through lack of evidence The primary aim of this trial will be to compare ceasing humidification at day 8 of life versus a gradual weaning protocol on maintaining body temperatures between 36.5°C – 37.5°C. We suspect that premature infants may benefit from being nursed in a humidified environment for longer than the standard one week which is currently provided.

The main purpose of this study is to determine what dose and frequency of medicinal cannabis is the best to relieve key symptoms in people with advanced cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or more, have a confirmed diagnosis of advanced cancer, with significant symptoms of severe pain, and/or vomiting, and/or nausea and/or lack of appetite that are poorly controlled by usual treatments, and a predicted life expectancy of more than 3 months and less than 12 months. Study details All participants in the study will be prescribed one of a number of cannabis medicines. The cannabis product will be given in addition to the usual treatments for their advanced cancer symptoms. On the first day of treatment participants will have 5 blood samples collected over 4 hours to measure the levels of cannabis medicines in their blood. They will also complete some online questionnaires about how they feel and be monitored for side effects. Participants will remain enrolled in this trial and receive the cannabis medication prescribed at no cost until they are no longer able to take it or withdraw from the trial. Participants will be asked to complete regular online questionnaires and have a single blood sample taken every few weeks when they see the trial doctor, until they no longer receive the product and/or withdraw from the trial. It is hoped the information collected in this study will guide the use of cannabis medicines to control symptoms in people with advanced cancer.

Polycystic ovary syndrome (PCOS) is a major public health concern affecting young Australian women, with significant metabolic [diabetes] and reproductive [sub-fertility and menstrual disturbance] consequences that are underpinned by insulin resistance (IR). However, knowledge gaps remain in our understanding the mechanisms of IR in PCOS and if current exercise therapies can overcome these mechanisms. We hypothesis that transforming growth factor beta induced tissue fibrosis causes PCOS-specific IR and that high- intensity exercise will resolve PCOS-IR via its impact on tissue fibrosis. Using a four group cohort study in women with and without PCOS across the lean and overweight BMIs with measures of insulin sensitivity and advanced molecular techniques investigate tissue fibrosis as a mechanisms of IR in PCOS. In a sub-study randomized control trial in the of cohorts of overweight women with and without PCOS we will explore the impact of high-intensity intermittent training (HIIT) vs. no lifestyle coaching on this proposed mechanism of insulin resistance.

This study will investigate the treatment of head and neck lymphoedema in a head and neck cancer population. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have a previous diagnosis of oral, nasopharyngeal, oropharyngeal, laryngeal, or hypopharyngeal cancer treated with chemoradiation, postoperative radiation or definitive radiation with curative intent. Study details All participants will undergo measurements and lymphatic imaging of the head and neck using near infra-red fluorescence lymphatic imaging, in order to examine swelling. Participants will be randomly allocated (by chance) to receive either compression therapy or manual lymphatic drainage over a period of 6 weeks. Compression therapy involves wearing a compression neck/face support and a flat foam insert for up to 8 hours per 24 hours. Manual lymphatic drainage will be administered by a therapist twice a week and participants will also be trained to self-administer this therapy at home. Participants in both treatment groups will be evaluated after 6 weeks and 12 weeks of therapy in order to evaluate effect on lymphoedema. It is hoped that this study will help us to determine the most effective therapy modality to treat head and neck lymphoedema and will provide valuable information to inform future studies of this type.

This aim of this study is to evaluate the effects of acupressure on sleep quality of older persons living in residential care, within Australian context. Study participants will be older persons receiving services from aged care facilities and retirement village. They will be randomly assigned into intervention and control groups. The intervention group will receive acupressure (12-minute/session) three time a week for four weeks. Control group will receive routine care only. The primary outcome measures is sleep quality. The secondary outcomes are depression, anxiety and quality of life. The baseline data will be collected before commencing acupressure intervention (T0), followed by 4-week acupressure sessions. The outcome data will be collected at the end of intervention (T1) and two weeks after the intervention (T2).