ANZCTR search results

Orthokeratology (OK) lenses are rigid contact lenses that are designed to be worn during sleep. Their purpose is to reshape the front surface of the eye (cornea) in order to temporarily correct short-sightedness, also known as myopia. Although their primary aim is to correct myopia and provide clear unaided vision during the day, studies have shown that they also have an effect on slowing or stopping the progression of short-sightedness in children, termed myopia control. Currently, research is underway to understand centration of OK lenses and the optical effects as a result of centration which may promote myopia control. Hence this prospective study aims to understand the effects of peripheral corneal shape on lens decentration by determining treatment zone decentration resulted through lens decentration during OK lens wear. Outcomes of this study would help in designing OK lenses that help in achieving myopia control in a more desired manner.

What is this study about? The purpose of this study is to investigate if ZYN002 applied by massaging it into the upper thighs provides the same amount of drug as when it is applied by massaging it into the arms/shoulders after repeat doses (applied twice daily for 13 days and on the morning of Day 14). Two concentrations of ZYN002 will be tested; one concentration containing 4.2% cannabadiol (CBD) and one containing 7.5% CBD. The study will look at blood levels of the drug in the body after it is administered in these three body locations in different people. How safe and well tolerated ZYN002 is will also be investigated. Who is it for? You may be eligible to join this study if you are aged between 18 and 70 years and are in general good health. Study details: This study will enrol a maximum of 40 participants across 4 treatment groups with 10 participants in each group, and will investigate the amount of ZYN002 detected in blood samples after administration of the treatment. In each group, 8 participants will receive the active drug (ZYN002) and 2 will receive the placebo. A placebo is a gel that looks like ZYN002 but does not contain any active ingredients. You will not have a choice as to whether you receive ZYN002 or the placebo (you will be assigned randomly, like flipping a coin). Neither you nor the study staff will know if you are assigned to receive ZYN002 or the placebo as the allocation will be masked, although in an emergency, the study staff can find out. What does study participation involve? Participation in the study includes a screening visit during the 28 days before the first study treatment. Throughout the study participants will have various medical tests (physical examinations, vital signs measured, ECG measured, C-SSRS assessment and will have several blood and urine samples collected for laboratory analysis. Participants will report to the study centre on the day prior to the first day of treatment (Day 1) and will be required to remain in the study centre overnight for 15 nights, until Day 15. The study treatment will be applied twice daily for 13 days with one treatment on Day 14. Days 1-13, while at the study centre, you will apply your AM and PM treatment of ZYN002 or placebo gel. You will apply the study treatment to the treatment site assigned to you (either your upper arms/shoulders and/or your upper thighs). You will apply your dose of the study drug to clean, dry, intact skin, thoroughly massaging it into the application sites assigned. You will continue to massage study drug into the application site until the application site feels dry to the touch. This will take approximately 2-4 minutes. On Day 14 there will be only an AM dose. You will be discharged on Day 15 and return to the study centre on Day 20 for a follow-up assessment visit.

Adults diagnosed by a Neurologist with Functional Neurological Symptom Disorder with residual symptoms despite diagnosis and treatment as usual will be seen for four two hour sessions of psychodynamic therapy with a Psychiatrist incorporating a comprehensive psychiatric history and formulation followed by management recommendations. Family and carers will be invited to join the planning component of sessions. At the final session a personalised "farewell" letter will be given to participants and a medical letter will be sent to referring and other treating doctors incorporating managment recommendations. All participants will complete a questionnaire in person before each interview and again three months after the last session by phone. A clinician administered measure of dissociation will be completed in the first appointment and again at the final session and during the follow up phone call. A modified adult attachment interview (AAI) will be incorporated into the first session for subsequent analysis. The assessments will be voice recorded for later assessment of interaction and adjherence to protocol by a supervisor and will be transcribed externally for thematic analysis and production of a case series. The clinician will also complete a HoNOS measure about the patient after each session and after the follow up phone call three months after the last session.. Statistical analysis will compare measures from before the first and last sessions as well as the measures at follow-up. The therapeutic interactions and patient narratives will be explored for themes. Rates and nature of additional psychiatric diagnoses in this population will be described. Modified Adult Attachment Interviews and Shutdown Dissociation interviews will be scored to indicate rates of each attachment style and rates of dissociation. Collaborative formulations which are agreed upon with the participants will be used to produce a case series.

PRE-BIOTIC will be the world’s first randomised controlled trial (RCT) of anabolic exercise (high intensity PRT) for patients with active inflammatory bowel disease (IBD) who remain symptomatic despite robust medical treatment. Although current treatment is effective in controlling a number of their symptoms, there is a need for better options to prevent disease, increase response and sustain remission. Exercise is one potential complementary strategy to combat IBD and other diseases, and there is rapidly growing evidence that it may also positively and substantially affect the gut biome, and thus could play a role in both prevention and treatment of IBD. Among exercise modalities, the rationale for resistance training (PRT) in IBD is extremely strong, as it has many of the same benefits of aerobic exercise with regards to cardio-metabolic profile and inflammation, but in addition, due to its anabolic nature, provides unique benefits not seen with aerobic exercise, including increases in muscle strength and mass, bone density and appetite. An anabolic/anti-inflammatory intervention such as PRT is theoretically able to change the underlying pathophysiology of this condition, in addition to addressing important physical and psychological symptoms. The global impact and relief of suffering for these individuals and their loved ones would be unprecedented.

About 20-30% of patients with angina have no obstructive coronary artery disease on coronary angiogram (NoCAD). Despite no significant obstructive coronary artery disease, most of these patients continue to experience recurrent chest pain without any definitive diagnosis. Comprehensive invasive coronary haemodynamic studies at the time of diagnostic coronary angiogram will provide important diagnostic and prognostic implications for the management of coronary vasomotor disorder, but routine assessment is difficult. The hyperaemic microvascular resistance (HMR) is a reliable but invasive measure to assess coronary microvascular function. The planned project will evaluate whether left ventricular contractile reserve (CR), measured with strain imaging on low dose dobutamine stress echocardiography (DSE), is a reliable non-invasive measure of coronary microvascular function.

Preliminary evidence now exists for the efficacy of the K-SLP approach. Recently, a case report was published which used a multimodal approach combining K-SLP with sign language and oral-motor therapy (Tierney, Pitterle, Kirtz, Nakhla, & Todorow, 2016). This was followed by two separate single case multiple-baseline within-subject experimental designs (SCED) on a total of 6 children (Gomez, McCabe, Purcell, & Jakielski, 2017; Gomez, McCabe, Purcell, & Jakielski, in press). The results of the two SCED studies has provided some positive results indicating feasibility and positive treatment outcomes. This research will continue to expand the evidence base for CAS treatment by completing a pilot randomized controlled trial (RCT) comparing the K-SLP approach to standard treatment. This research may also provide insight into what comprises standard treatment for CAS. This research is important as it provides speech-language pathologists with additional external evidence to ensure that they are providing an efficacious treatment approach for CAS, in accordance with their ethical obligation as allied health professionals.

The purpose of this research is to test an exercise and wellness program for haematology in-patients receiving cancer treatment. Who is it for? You may be eligible for this study if you are undergoing treatment for a haematological malignancy at the Calvary Mater Newcastle Hospital which requires you to be in hospital for at least 7 days. Study details Each participant will be assessed by a physiotherapist (face to face) and provided with a personalised exercise program (30-60 minutes duration of strength and balance + walking) tailored to be performed daily while in hospital. Each participant will also be given written information on diet, nutrition, and exercise. This study will help to determine adherence and satisfaction of patients and staff to a personalised exercise program while in hospital.

The aim of the study is to determine the impact of pre and post-operative rehabilitation provided through a digital application on Clinical and Hospital Outcomes. Clinical outcome will assessed with patient reported outcome measures and knee range of motion. Hospital outcomes measured will include length of stay and inpatient and rehabilitation costs attributed to care after TKA. Patients who are selected for Total Knee Arthroplasty (TKA) and agree to participate in the study will be randomly assigned to a control or experimental group. The control group will be provided current standard care prior to and after their surgery. The experimental group will be provided a pre and post-operative rehabilitation program consisting of Physiotherapy exercises through a mobile electronic application. The program will be monitored and modified by one Physiotherapist. The experimental group will be able to contact the Physiotherapist via telephone or email at any point during the program to discuss their progress. Patients can choose to opt in and opt out of the digital rehabilitation program and will be included in the analysis on an intention to treat basis. Prior to surgery, patient reported outcome measures will be collected to determine the patient’s pre-operative state. After surgery, various patient reported outcomes measures will be collected at two weeks, six weeks and three months to assess patient satisfaction, self-perceived confidence, pain levels and return to function. Patient reported outcome measuress will be captured via a tablet, email and / or letter, based on patient preference. Patient range of motion will be collected pre-operatively and at six weeks post-operatively by the treating surgeon. Hospital data collected will include length of stay, decision for ongoing rehabilitation and complications, which are collected as part of the hospital record. The digital application collects data on patient compliance and reported pain levels whilst using the program. Analysis will be performed between the two groups to determine the impact of pre and post-operative digital rehabilitation on clinical and hospital outcomes after TKA surgery.

This study will design and test the feasibility, acceptability and potential effectiveness of a tailored implementation strategy to improve speech pathologists’ uptake of evidence in two areas of practice: Goal Setting and Information, Education and Aphasia-friendly information. Multifactorial interventions targeting the main barriers identified in the qualitative study will be designed, using evidence-based behaviour change interventions The aims of this project are: (1) To design and test the feasibility, acceptability and potential effectiveness of an implementation strategy to improve speech pathologists’ provision of tailored information to people with aphasia and their carers in the acute hospital setting, (2) To design and test the feasibility, acceptability and potential effectiveness of an implementation strategy to improve speech pathologists’ use of collaborative goal setting with people with aphasia in the acute hospital setting, and (3) To investigate the effect of the implementation strategy/ies on the hypothesised predictors of clinician behaviour (the main barriers). It is hypothesised that a targeted implementation strategy will change clinician’s behaviour in the area of interest (i.e. information provision or goal-setting) and have no effect on the behaviour not being targeted. A pilot cluster randomised controlled trial will be used. Clusters will be speech pathology departments within hospitals. Medical records will be audited pre- and post- intervention at all hospitals to assess the proportion of patients who received aphasia-friendly information and who engaged in collaborative goal setting with their treating speech pathologist. Focus groups will be conducted to determine participants' feedback on the interventions and to determine feasibility and acceptability of the interventions.

This project will comprise of a randomised control trial (RCT). The hypothesis will be tested by randomly allocating participants into two groups; the ImPress intervention and a control group. Clinical differences between these groups will be assessed at 6 and 12 months follow-up. The primary goal of conducting this trial is to evaluate if the ImPress intervention is more effective than usual care in achieving optimal blood pressure control, medication adherence, behavioural risk factors and body mass index in general practice. Randomisation will occur at a practice level and data will be collected by the GPN at baseline, six and twelve months when patients attend the practice. A total sample of 200 patients across 20 practices will be sought. .Once Practices have been recruited, participating GPNs will conduct a structured electronic search of the practice medical record database to identify a list of eligible patients. Following the assessment visit and study enrollment, patients will attend three face to face GPN appointments and two telephone consultations throughout intervention. All consultations will be underpinned by a person centred approach with the GPN utilising motivational interviewing techniques and the 5 As’ to build rapport, set goals and offer support for self-management. While the aim of first GPN consultation is to record baseline BP, biometric measures and lifestyle risks, this initial encounter is an opportunity to build rapport and shared understanding. Subsequent visits will focus on individualised action planning in partnership with the patient, goal setting and feedback on progress. Templates to structure each nursing assessment will be uploaded to the practices computerised clinical files in Director or Best Practice. GPNs will be encouraged to collaborate with the participating GP(s) to share information around the nursing care being provided.