ANZCTR search results

This clinical trial will investigate the safety and efficacy of a 14-week MDMA assisted psychotherapy treatment for PTSD. The primary outcome measure will assess clinician-rated changes in PTSD severity, alongside a range of secondary and exploratory measures assessing functional impairment associated with PTSD, quality of life, relationships to adverse childhood experiences, and changes in comorbid psychiatric symptoms. Safety outcome measures will also investigate the safety and tolerability of the drug.

When an ischaemic stroke occurs and a major artery is blocked with a clot, some blood flow is re-routed to the stroke site via ‘bypass’ blood vessels (called collateral vessels) in order to prevent more brain cells from dying. Failure of these bypass vessels mean a stroke can continue to expand and the damage to the brain gets worse. Increased pressure in the skull, which occurs after stroke, can cause failure of these bypass vessels and thus make a stroke worse. We hypothesise that by removing some cerebrospinal fluid (the fluid that surrounds your brain) we can prevent pressure elevation after a stroke and therefore make the stroke less severe. The first thing we have to do is check whether we can safely take some cerebrospinal fluid from stroke patients. That is what this trial is designed to look at, whether we can safely take some cerebrospinal fluid from stroke patients.

The research project will investigate the feasibility and acceptability of training community-dwelling older adults with cognitive impairment and decreased mobility and their carers of the safe mobilisation strategies in inpatient geriatric rehabilitation. It will also explore the potential effectiveness of the program on risk of falls. The project aims to recruit 30 participants, with 15 participants in the intervention group and control group respectively. The 2-week intervention program will be carried out by allied health staff (occupational therapists and physiotherapists) in an inpatient rehabilitation setting to train the participants and their family members/carers safe mobilisation strategies in addition to usual care, These strategies will focus on behavioural change and safe habit formation to manage decreased functional mobility that contribute to increased risk of falls. The intervention will be integrated into gait and functional training and fall prevention education. The control group will receive usual care, which includes functional and gait training, fall prevention education, home assessment and hazard reduction, installation of equipment and modification as required. As the program will integrate the intervention into existing rehabilitation services, this research project will provide insight in efficient and effective ways of reducing fall risks in this population, and the data obtained from the study will inform large scale clinical trails in public and private rehab settings and possible community centres.

Connect Local is a new codesigned social prescribing program that aims to support older community members with at least one chronic health condition who may be experiencing or are at risk of loneliness, social isolation and /or depressive symptoms to links them into local social community activities/programs. The aim of the program is to reduce loneliness, social isolation and/or depressive symptoms and improve physical, mental and social wellbeing. Connect Local has been developed through codesign (2021-2022) including local community stakeholders with the aim to develop a program that is fit for purpose, feasible and sustainable. This evaluation includes program effectiveness, health economic and implementation evaluation. Using a Type 1 Hybrid effectiveness-implementation design permits testing of the outcomes of the intervention while gathering information on its implementation. This information will support the rollout and inform sustainability of Connect Local more broadly.

Rationale: Retained products of conception (RPOC) is the presence of fetal and/or placental tissue within the uterus post-delivery (preterm or term), miscarriage or termination. It has a prevalence of 0.5-19% and is most commonly seen after second trimester delivery and termination of pregnancy. Most women with RPOC are symptomatic with uterine bleeding, pelvic pain, fevers and/or uterine tenderness, however, some can be initially asymptomatic and have delayed issues such as amenorrhea and infertility from intra-uterine adhesions. For this reason effective treatment for the management of RPOC is important. There are currently no comparative papers assessing medical versus surgical management of retained products of conception. Often patients trial expectant or medical management, but this is unsuccessful in about 20% of cases. The two main surgical options are dilatation and curettage (D&C) or operative hysteroscopy with resectoscopic techniques. The advantage of an operative hysteroscopy over a dilatation and curettage is that it allows for selective resection under direct vision and is therefore beneficial when other methods have failed, there is a significant amount/vascular RPOC, or there are concerns about interruption or damage to surrounding endometrium. Unfortunately, a systematic review by our group, concluded that the current evidence was inadequate to confirm one surgical technique superior to the other. Hysteroscopic morcellation has been increasingly used in management of intra-uterine pathology, however, only one study by Hamerlynck et al has compared it to bipolar resection in the management of RPOC, specifically with the use of the TruClear (Medtronic). The TruClear device is not available in Australia. This pilot aims to assess the feasibility of our study design, and provide data to allow sample size calculation for the larger study. Objectives: The overall objective of the future full study is to compare operative hysteroscopy with MyoSure XL (Hologic, Inc) intrauterine morcellation to bipolar loop resection in the management of RPOC, in terms of both short-term (surgical efficiency and safety) and long-term outcomes (fertility outcomes). The null hypothesis is that there will be no difference in outcomes. However, we need the pilot data prior to plan this final study, hence this proposed pilot. Methodological Approach: An open label, pilot randomised control trial at Mercy Hospital for Women, a tertiary hospital in Melbourne, Australia. Mercy serves as a referral hospital for operative hysteroscopic management of RPOC. Hysteroscopic morcellation has had good outcomes in the resection of intrauterine pathology (such as fibroids and polyps) and has therefore increasingly also been used in women with RPOC. The more traditionally used method is resection with a bipolar resectoscope; therefore, this will be the choice for the control arm.

Background:: Optimising gastric conduit emptying post oesophagectomy is key to improving morbidity outcomes in a cohort of patients with increasingly long survivorship. It is thought that peristaltic function and resultant emptying of the gastric conduit improves over time. However, the relationship between peristalsis and conduit emptying has not been precisely delineated, nor has the presumed recovery. Aims:: In this study, we aim to investigate dynamic MRI as a technique to measure gastric conduit peristalsis in the mediastinum. We will use it to quantify the degree of peristalsis in the established gastric conduit and assess its correlation with emptying. We will also use quality of life and adverse symptom questionnaires to look for a relationship between peristalsis and gastrointestinal quality of life. Hypothesis: Dynamic MRI is an accurate way to measure gastric conduit peristalsis and conduit emptying. Peristaltic activity recovers post oesophagectomy and is more effective in narrower conduits. Brief Methods: Post oesophagectomy patients will be recruited greater than 2 years post oesophagectomy. Dynamic MRI will be performed, and questionnaires and demographic data collected Patients greater than 2 years post oesophagectomy and gastric conduit reconstruction will be prospectively recruited. Static and Dynamic MRIs will be performed in the supine position post consumption of a semisolid meal. Speed, length, and amplitude of peristaltic waves will be measured at 4 time points over a 20-minute period. Gastric Motility Index mm2/s (GMI) will be calculated (velocity x amplitude of peristaltic wave). Gastric conduit volumes will be calculated at the start and end of each MRI.

Falls are a major cause of preventable injury, hospitalisation, morbidity, and mortality in older adults. 1 in 3 people aged 65 years or greater living at home experience a fall annually. Emerging evidence indicates obstructive sleep apnea (OSA), a common sleep breathing disorder (~50%) in older people, may be an independent contributor to fall risk. Balance and gait decline with time awake and can vary across the circadian cycle with specific periods of vulnerability (e.g., transition in posture, standing up and toileting). In addition, the severity of OSA varies significantly from night to night, which may exacerbate gait abnormalities and fall risk in older people. There is currently a lack of robust evidence that OSA treatment reduces fall risk, hence, OSA is currently ignored in falls prevention and reduction strategies. To address this knowledge gap, our internationally recognised team of clinicians and researcher experts in sleep health, fall risk prevention and rehabilitation will build on our successful uncontrolled pilot study and propose to conduct a randomised controlled trial (RCT) to : (1) establish if treatment of OSA with 6 months of CPAP reduces fall risk markers and improves daytime gait quality, (2) provide first in field insight into the temporal relationship between night-to-night variation in OSA with next day gait quality to identify periods of potential increased vulnerability to falls. We hypothesise that 6 months of CPAP treatment will reduce fall risk markers and improve walking and balance.

We plan to explore the feasibility of providing human albumin infusions in the home setting by community nurses.

This 3 year study will observe longitudinal changes to vision in glaucoma using two different visual field testing (perimetry) methods. Glaucoma is a disease of the optic nerve in which peripheral vision is lost. Visual damage in glaucoma is typically measured using a visual field test, which measures the ability to see small white-light targets at various locations spread across the visual field. Current visual field tests use the same test pattern for all people with glaucoma. The primary aim of this study is to observe whether alternate test grids enable earlier detection of progressive damage to the visual field. Clinicians use visual field test information in combination with information from imaging of the eye to make decisions regarding whether people need more treatment. The secondary aim of this study is to combine the information from the visual field tests with information from retinal imaging to improve understanding of how glaucoma progresses.

This study is evaluating the safety and properties of 177Lu-RAD204, a PD-L1 antibody joined to a radioactive lutetium isotope. Who is it for? You may be eligible for this study if you are an adult patient with confirmed PD-L1 positive solid tumours including non small cell lung cancer (NSCLC), small cell lung cancer (SCLC), triple negative breast cancer (TNBC), cutaneous melanoma, head and neck squamous cell carcinoma (HNSCC) and endometrial cancer that is unresectable, progressive and for which standard treatment measures are no longer effective. Study details Participants will undergo a Screening Period of up to 4 weeks, followed by a Phase 0 (Imaging) Period for imaging and receiving a single injection of 177Lu-RAD204. If they are able to tolerate this in the following 2 week period, they will then proceed to a Phase I (Treatment) Period where they will be assigned a dose of 177Lu-RAD204 delivered every 6 weeks for 3 cycles. Blood sampling and imaging studies will be performed to determine how the participant is responding to 177Lu-RAD204. Additional treatment cycles (beyond 3 cycles) will be considered if participant is deemed to receive clinical benefit from 177Lu-RAD204 and approved by study Sponsor. Findings from this study will help determine a recommended dose of 177Lu-RAD204 for future exploration