1,685 results match your criteria: "NHMRC Clinical Trials Centre[Affiliation]"

Study Question: Compared to the 'single biopsy + single vitrification' approach, do 'double biopsy + double vitrification' or 'single biopsy + double vitrification' arrangements compromise subsequent clinical outcomes following euploidy blastocyst transfer?

Summary Answer: Both 'double biopsy + double vitrification' and 'single biopsy + double vitrification' led to reduced live birth/ongoing pregnancy rates and clinical pregnancy rates.

What Is Known Already?: It is not uncommon to receive inconclusive results following blastocyst biopsy and preimplantation genetic testing for aneuploidy (PGT-A). Often these blastocysts are warmed for re-test after a second biopsy, experiencing 'double biopsy + double vitrification'.

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Most older people with kidney failure choose between treatment with dialysis or conservative kidney management. The preferences underlying these decisions are poorly understood. Here, we performed a choice experiment, informed by qualitative research, to examine preferences for the characteristics of dialysis and conservative management among over-65-year-olds with eGFR of 20 mls or under/min/1.

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Article Synopsis
  • Regorafenib, an oral multikinase inhibitor, was tested in the INTEGRATE IIa trial to see if it improves overall survival in patients with advanced gastric and esophagogastric junction cancer who did not respond to at least two prior treatments.
  • The trial compared regorafenib plus supportive care against a placebo with supportive care, enrolling 251 participants and evaluating various outcomes like overall survival (OS), progression-free survival (PFS), and quality of life (QoL).
  • Results showed that regorafenib significantly improved OS and PFS compared to placebo, with a median OS of 4.5 months for those receiving regorafenib versus 4.0 months for those on placebo, while also
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Real-World Implementation of Simulation-Free Radiation Therapy (SFRT-1000): A Propensity Score-Matched Analysis of 1000 Consecutive Palliative Courses Delivered in Routine Care.

Int J Radiat Oncol Biol Phys

September 2024

Department of Radiation Oncology, Northern Sydney Cancer Centre, Royal North Shore Hospital, Sydney, New South Wales, Australia; Sydney Medical School, University of Sydney, Sydney, New South Wales, Australia.

Purpose: The feasibility of simulation-free radiation therapy (SFRT) has been demonstrated but information regarding its routine care impact and scalability is lacking.

Methods And Materials: In this single-institution, retrospective cohort study, all patients receiving palliative radiation therapy at an Australian tertiary cancer center were eligible for consideration of SFRT unless mask immobilization, a stereotactic technique, or a definitive dose was indicated. Coprimary endpoints were SFRT utilization, impact on consultation-to-RT time, and on-couch treatment duration.

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Introduction: We showed in a phase II randomised controlled trial (RCT) that oral sildenafil citrate in term labour halved operative birth for fetal distress. We outline the protocol for a phase III RCT (can ntrapartum ildnafil safely vert the isks of ontraction-induced ypoxia? (iSEARCH)) of 3200 women in Australia to assess if sildenafil citrate reduces adverse perinatal outcomes related to intrapartum hypoxia.

Methods And Analysis: iSEARCH will enrol 3200 Australian women in term labour to determine whether up to three 50 mg oral doses of sildenafil citrate versus placebo reduce the relative risk of a primary composite end point of 10 perinatal outcomes potentially related to intrapartum hypoxia by 35% (from 7% to 4.

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Article Synopsis
  • - The RidStress 2 trial is a phase III study investigating whether maternal oral sildenafil citrate during labor can reduce the need for emergency caesarean sections due to fetal distress in women with small for gestational age infants.
  • - The trial involves 660 women and aims to determine the effect of sildenafil citrate on cesarean rates, along with assessing cost-effectiveness and long-term child neurodevelopment.
  • - Ethics approval has been secured, and results will be shared through scientific presentations and publications, with the trial registered with relevant clinical trial authorities.
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Article Synopsis
  • ALK-positive lung cancers exhibit molecular diversity and pose challenges due to treatment resistance, prompting the need for innovative strategies using ctDNA monitoring.
  • The ALKTERNATE pilot study analyzed alternating treatments of lorlatinib and crizotinib in patients resistant to previous ALK inhibitors, focusing on outcomes like treatment failure time, safety, and patient experiences.
  • Results showed that the alternating therapy was safe and effective for most participants, with an average treatment failure time of 10 months and overall survival of 23 months, indicating the importance of genetic factors in treatment response.
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Background And Hypothesis: Studies in patients with heart failure have indicated that sodium-glucose cotransporter 2 (SGLT2) inhibitors increase iron use and enhance erythropoiesis. In this post-hoc analysis of the CREDENCE trial, we evaluated the effects of canagliflozin on iron metabolism in patients with chronic kidney disease (CKD) and whether the effects of canagliflozin on hemoglobin and cardiorenal outcomes were modified by iron deficiency.

Methods: We measured serum iron, total iron binding capacity (TIBC), transferrin saturation (TSAT) and ferritin at baseline and 12 months.

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Importance: Observed treatment effects on overall survival (OS) differed substantially in the first 2 randomized clinical trials of lutetium Lu 177 vipivotide tetraxetan (Lu-177) prostate-specific membrane antigen (PSMA) in metastatic castration-resistant prostate cancer.

Objective: To investigate factors associated with the observed difference in treatment effects on OS, including differences in the risk of crossover from randomized treatment after disease progression.

Design, Setting, And Participants: This comparative effectiveness study used individual participant data from 2 randomized clinical trials, TheraP (A Randomised Phase 2 Trial of 177Lu-PSMA617 Theranostic Versus Cabazitaxel in Progressive Metastatic Castration Resistant Prostate Cancer [ANZUP Protocol 1603]) (n = 200), recruited from February 2018 to September 2019 in Australia, and published data from VISION (An International, Prospective, Open Label, Multicenter, Randomized Phase 3 Study of 177Lu-PSMA-617 in the Treatment of Patients With Progressive PSMA-Positive Metastatic Castration-Resistant Prostate Cancer) (n = 831), recruited from June 2018 to October 2019 in North America and Europe.

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Background: Global policy and guidelines for low back pain (LBP) management promote physical activity and self-management yet adherence is poor and a decline in outcomes is common following discharge from treatment. Health coaching is effective at improving exercise adherence, self-efficacy, and social support in individuals with chronic conditions, and may be an acceptable, cost-effective way to support people in the community following discharge from treatment for LBP.

Aim: This qualitative study aimed to understand which aspects of a community over-the-phone health-coaching program, were liked and disliked by patients as well as their perceived outcomes of the service after being discharged from LBP treatment.

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Background: Heart failure (HF) is a complex syndrome associated with high morbidity and mortality and increased healthcare utilisation. Patient education is key to improving health outcomes, achieved by promoting self-management to optimise medical management. Newer digital tools like text messaging and smartphone applications provide novel patient education approaches.

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Background: Data sharing improves the value, synthesis, and integrity of research, but rates are low. Data sharing might be improved if data sharing policies were prominent and actionable at every stage of research. We aimed to systematically describe the epidemiology of data sharing policies across the health research lifecycle.

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Introduction: Patient-reported outcome measures (PROMs) are validated and standardised questionnaires that capture patients' own reports of their symptoms, functioning and well-being. PROMs can facilitate communication between patients and clinicians, reduce symptom burden, enhance quality of life and inform health service re-design. We aim to determine the acceptability of PROMs and the preferred timing of PROM completion in New South Wales (NSW) at the point of care, facilitated by the Health Outcomes and Patient Experiences (HOPE) platform.

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Lifetime effects and cost-effectiveness of statin therapy for older people in the United Kingdom: a modelling study.

Heart

October 2024

Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.

Background: Cardiovascular disease (CVD) risk increases with age. Statins reduce cardiovascular risk but their effects are less certain at older ages. We assessed the long-term effects and cost-effectiveness of statin therapy for older people in the contemporary UK population using a recent meta-analysis of randomised evidence of statin effects in older people and a new validated CVD model.

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This single-arm phase II non-randomised trial (ACTRN12619001265167) evaluated trastuzumab emtansine in solid cancers with HER2 amplification or mutation detected by comprehensive genomic profiling. The primary objective was objective response (OR), while secondary objectives included the time to progression (TTP) on study to TTP on prior therapy ratio, progression-free survival (PFS) and overall survival (OS). The cohort included 16 tumours with HER2 mutations (group 1) and 16 with HER2 amplification (group 2).

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Association between surgical admissions, cognition, and neurodegeneration in older people: a population-based study from the UK Biobank.

Lancet Healthy Longev

September 2024

Department of Anaesthetics, Royal Prince Alfred Hospital, Sydney Local Health District, Sydney, NSW, Australia; NHMRC Clinical Trials Centre, The University of Sydney, Sydney, NSW, Australia; Central Clinical School, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia.

Background: Previous studies have shown that major surgical and medical hospital admissions are associated with cognitive decline in older people (aged 40-69 years at recruitment), which is concerning for patients and caregivers. We aimed to validate these findings in a large cohort and investigate associations with neurodegeneration using MRI.

Methods: For this population-based study, we analysed data from the UK Biobank collected from March 13, 2006, to July 16, 2023, linked to the National Health Service Hospital Episode Statistics database, excluding participants with dementia diagnoses.

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Objective: Imaging for staging ovarian cancer is important to determine the extent of disease. The primary objective of this study was to compare gated 18F-fluorodeoxyglucose positron emission tomography coupled with computed tomography (FDG PET/CT) and standard CT scan with intravenous contrast to diagnose thoracic involvement in patients with advanced ovarian cancer prior to treatment. The secondary objective was to estimate changes in the International Federation of Gynecology and Obstetrics (FIGO) stage and clinical management resulting from gated PET/CT.

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Background And Objective: Randomized controlled trials (RCTs) inform health-care decisions. Unfortunately, some published RCTs contain false data, and some appear to have been entirely fabricated. Systematic reviews are performed to identify and synthesize all RCTs which have been conducted on a given topic.

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Article Synopsis
  • The GCIG Endometrial Cancer Consensus Conference was held in Incheon, South Korea, aimed at creating consensus statements to improve future clinical trials in endometrial cancer.
  • Representatives from 33 member groups developed 18 statements across four key topics, focusing on treatment strategies and trial methodologies, including consideration for low-resource settings.
  • For the first time, the conference included patient advocates and early-career investigators, resulting in a high consensus rate on the statements, reinforcing progress in global clinical research for endometrial cancer.
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Background: Delirium and Alzheimer's disease (AD) are common causes of cognitive dysfunction among older adults. These neurodegenerative diseases share a common and complex relationship, and can occur individually or concurrently, increasing the chance of permanent mental dysfunction. However, the common molecular pathophysiology, key proteomic biomarkers, and functional pathways are largely unknown, whereby delirium is superimposed on AD and dementia.

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