https://ogma.newcastle.edu.au/vital/access/ /manager/Index ${session.getAttribute("locale")} 5 A cost-consequence analysis of normalised advance care planning practices among people with chronic diseases in hospital and community settings https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:48708 Wed 29 Mar 2023 17:38:39 AEDT ]]> Zinc supplementation in pre-diabetes mellitus: a systematic review and meta-analysis. https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:43691 Wed 28 Sep 2022 14:35:49 AEST ]]> The RESOLVE Trial for people with chronic low back pain: statistical analysis plan https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:43490 Wed 28 Sep 2022 10:57:28 AEST ]]> A phase III, multi-arm multi-stage covariate-adjusted response-adaptive randomized trial to determine optimal early mobility training after stroke (AVERT DOSE) https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:51317  2) and hemorrhagic stroke. With four arms per stratum (reference arm retained throughout), only the single treatment arm demonstrating the highest proportion of favorable outcomes at the first stage will proceed to the second stage in each stratum, resulting in a final comparison with the reference arm. Three prognostic covariates of age, geographic region and reperfusion interventions, as well as previously observed mRS 0-2 responses inform the adaptive randomization procedure. Participants randomized receive prespecified mobility training regimens (functional task-specific), provided by physiotherapists/nurses until discharge or 14 days. Interventions replace usual mobility training. Fifty hospitals in seven countries (Australia, Malaysia, United Kingdom, Ireland, India, Brazil, Singapore) are expected to participate. Summary: Our novel adaptive trial design will evaluate a wider variety of mobility regimes than a traditional two-arm design. The data-driven adaptions during the trial will enable a more efficient evaluation to determine the optimal early mobility intervention for patients with mild and moderate ischemic stroke.]]> Wed 28 Feb 2024 15:05:25 AEDT ]]> Stereotactic ablative body radiotherapy for primary kidney cancer (TROG 15.03 FASTRACK II): a non-randomised phase 2 trial https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:54994 Wed 27 Mar 2024 16:38:54 AEDT ]]> Personality disorder and functioning in major depressive disorder: A nested study within a randomized controlled trial https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:45277 0.14). Conclusion: In this secondary analysis of a primary efficacy study, PD was a common comorbidity among those with MDD, but was not a significant predictor of functional outcomes. This study adds to the limited literature on PD in randomized controlled trials for MDD.]]> Wed 26 Oct 2022 17:13:15 AEDT ]]> Defining reliable disability outcomes in multiple sclerosis https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:22648 Wed 22 May 2019 14:50:34 AEST ]]> Defining the trials nurses’ role in operationalising a medicinal cannabis clinical trial https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:48551 Wed 22 Mar 2023 09:14:40 AEDT ]]> Clinical trials of medicinal cannabis for appetite-related symptoms from advanced cancer: a survey of preferences, attitudes and beliefs among patients willing to consider participation https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:29481 n = 144, 71%), followed by mouth spray (n = 84, 42%) and vaporiser (n = 83, 41%). Explanations for preferences (n = 134) most commonly cited convenience (n = 66; 49%). A total of 82% (n = 168) of respondents indicated that they had no trial-related concerns, but a small number volunteered concerns about adverse effects (n= 14) or wanted more information/advice (n = 8). Six respondents volunteered a belief that cannabis might cure cancer, while two wanted assurance of efficacy before participating in a trial. Conclusion: Justification of modes other than tablets/capsules and variable understanding about cannabis and trials will need addressing in trial-related information to optimise recruitment and ensure that consent is properly informed.]]> Wed 17 Nov 2021 16:32:30 AEDT ]]> Efficacy of Helicobacter pylori eradication regimens in Rwanda: a randomized controlled trial https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:44401 Wed 12 Oct 2022 14:29:34 AEDT ]]> Spontaneous and tetracosactide-induced anti-ACTH antibodies in man https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:23884 1-24) antibodies. Design: Anti-ACTH binding activity was investigated using immunoblotting and ELISA on sera from participants in the trial (n = 13; baseline and after tetracosactide exposure), 131 unrelated patients with AAD, 92 patients with Graves' disease (GD), 15 patients with isolated ACTH deficiency and 102 controls. Immunohistochemistry of human pituitary tissue sections was also performed using pooled sera. Results: Bands at approximately 4 and 6 kDa, corresponding to ACTH1-24 and full-length ACTH1-39, respectively, were found in 10 of 13 (77%) of sera from trial patients exposed to tetracosactide, including all those who had an adverse reaction. This is in contrast with healthy control sera, which showed no binding. The same 10 subjects also showed high levels of binding to tetracosactide by ELISA, along with 21% of patients with AAD, 14% of patients with GD (both P < 0·001 compared to controls) and 1 isolated ACTH deficiency patient (7% of 15). These sera also recognized native ACTH in human pituitary sections. Conclusion: Our study demonstrates that repeated administration of depot tetracosactide can lead to anti-ACTH1-24 autoreactivity. In addition, a significant number of patients with AAD and GD also had similar, spontaneous, anti-ACTH reactivity. The presence of these antibodies could mediate some of the adverse effects or explain the well-described phenomenon of resistance to chronic ACTH therapy.]]> Wed 11 Apr 2018 12:16:46 AEST ]]> Electromagnetic-guided MLC tracking radiation therapy for prostate cancer patients: prospective clinical trial results https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:44516 95% of fractions were successfully delivered. The secondary outcomes were (1) the improvement in beam-target geometric alignment, (2) the improvement in dosimetric coverage of the prostate and avoidance of critical structures, and (3) no acute grade ≥3 genitourinary or gastrointestinal toxicity. Results: All 858 planned fractions were successfully delivered with MLC tracking, demonstrating the primary outcome of feasibility (P < .001). MLC tracking improved the beam-target geometric alignment from 1.4 to 0.90 mm (root-mean-square error). MLC tracking improved the dosimetric coverage of the prostate and reduced the daily variation in dose to critical structures. No acute grade ≥3 genitourinary or gastrointestinal toxicity was observed. Conclusions: Electromagnetic-guided MLC tracking radiation therapy for prostate cancer is feasible. The patients received improved geometric targeting and delivered dose distributions that were closer to those planned than they would have received without electromagnetic-guided MLC tracking. No significant acute toxicity was observed.]]> Wed 09 Nov 2022 10:02:12 AEDT ]]> Factors Associated With Placebo Treatment Response in Functional Dyspepsia Clinical Trials https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:50841 Wed 09 Aug 2023 09:10:43 AEST ]]> Inhaled budesonide in the treatment of early COVID-19 (STOIC): a phase 2, open-label, randomised controlled trial https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:49074 40 years), sex (male or female), and number of comorbidities (≤1 and ≥2). Randomisation was done using random sequence generation in block randomisation in a 1:1 ratio. Budesonide dry powder was delivered using a turbohaler at a dose of 400 μg per actuation. Participants were asked to take two inhalations twice a day until symptom resolution. The primary endpoint was COVID-19-related urgent care visit, including emergency department assessment or hospitalisation, analysed for both the per-protocol and intention-to-treat (ITT) populations. The secondary outcomes were self-reported clinical recovery (symptom resolution), viral symptoms measured using the Common Cold Questionnare (CCQ) and the InFLUenza Patient Reported Outcome Questionnaire (FLUPro), body temperature, blood oxygen saturations, and SARS-CoV-2 viral load. The trial was stopped early after independent statistical review concluded that study outcome would not change with further participant enrolment. This trial is registered with ClinicalTrials.gov, NCT04416399. Findings: From July 16 to Dec 9, 2020, 167 participants were recruited and assessed for eligibility. 21 did not meet eligibility criteria and were excluded. 146 participants were randomly assigned—73 to usual care and 73 to budesonide. For the per-protocol population (n=139), the primary outcome occurred in ten (14%) of 70 participants in the usual care group and one (1%) of 69 participants in the budesonide group (difference in proportions 0·131, 95% CI 0·043 to 0·218; p=0·004). For the ITT population, the primary outcome occurred in 11 (15%) participants in the usual care group and two (3%) participants in the budesonide group (difference in proportions 0·123, 95% CI 0·033 to 0·213; p=0·009). The number needed to treat with inhaled budesonide to reduce COVID-19 deterioration was eight. Clinical recovery was 1 day shorter in the budesonide group compared with the usual care group (median 7 days [95% CI 6 to 9] in the budesonide group vs 8 days [7 to 11] in the usual care group; log-rank test p=0·007). The mean proportion of days with a fever in the first 14 days was lower in the budesonide group (2%, SD 6) than the usual care group (8%, SD 18; Wilcoxon test p=0·051) and the proportion of participants with at least 1 day of fever was lower in the budesonide group when compared with the usual care group. As-needed antipyretic medication was required for fewer proportion of days in the budesonide group compared with the usual care group (27% [IQR 0–50] vs 50% [15–71]; p=0·025) Fewer participants randomly assigned to budesonide had persistent symptoms at days 14 and 28 compared with participants receiving usual care (difference in proportions 0·204, 95% CI 0·075 to 0·334; p=0·003). The mean total score change in the CCQ and FLUPro over 14 days was significantly better in the budesonide group compared with the usual care group (CCQ mean difference −0·12, 95% CI −0·21 to −0·02 [p=0·016]; FLUPro mean difference −0·10, 95% CI −0·21 to −0·00 [p=0·044]). Blood oxygen saturations and SARS-CoV-2 load, measured by cycle threshold, were not different between the groups. Budesonide was safe, with only five (7%) participants reporting self-limiting adverse events. Interpretation: Early administration of inhaled budesonide reduced the likelihood of needing urgent medical care and reduced time to recovery after early COVID-19. Funding: National Institute for Health Research Biomedical Research Centre and AstraZeneca.]]> Wed 03 May 2023 16:14:55 AEST ]]> Phase 2 study of anastrozole in recurrent estrogen (ER)/progesterone (PR) positive endometrial cancer: the PARAGON trial – ANZGOG 0903 https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:45582 p = 0.002), cognitive functioning (45 vs 19%: p = 0.021), fatigue (47 vs 19%: p = 0.015) and global health status (42 vs 9%: p = 0.003). Conclusion: Although the objective response rate to anastrozole was relatively low, clinical benefit was observed in 44% of patients with ER/PR positive metastatic endometrial cancer and associated with an improvement in QOL.]]> Wed 02 Nov 2022 10:37:04 AEDT ]]> Participant experiences in a pilot study for methamphetamine withdrawal treatment: Implications for retention https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:55236 Wed 01 May 2024 15:39:47 AEST ]]> Prevalence of advance care planning practices among people with chronic diseases in hospital and community settings: a retrospective medical record audit https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:39502 n = 28) out of 1006 audited records, and only 10 (1%) of them were legally binding. The number of EGs appointed was 39 (3.9%) across the sites. A total of 151 (15.4%) resuscitation plans were found across the eight hospital sites. 95% (n = 144) of the resuscitation plans indicated ‘Not-for-resuscitation’. Conclusions: The uptake of ACP is very low. Current medical recording system reveals the challenges in ACP lie in the process of storage, access and execution of the ACDs. Given that having an ACD or Enduring Guardian in place is only useful if the treating physician knows how and where to access the information, it has implications for policy, information system, and healthcare professionals’ education. Trial registration: The study was retrospectively registered with the Australian New Zealand Clinical Trials Registry (Trial ID: ACTRN12618001627246). The URL of the trial registry record http://www.anzctr.org.au/trial/MyTrial.aspx]]> Tue 09 Aug 2022 14:39:05 AEST ]]> The association between the use of ivermectin and mortality in patients with COVID-19: a meta-analysis https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:43881 Tue 04 Oct 2022 13:45:29 AEDT ]]> Collective and negotiated design for a clinical trial addressing smoking cessation supports for Aboriginal and Torres Strait Islander mothers in NSW, SA and Qld - developing a pilot study https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:33553 Tue 03 Sep 2019 18:31:48 AEST ]]> L-Theanine and caffeine improve target-specific attention to visual stimuli by decreasing mind wandering: a human functional magnetic resonance imaging study https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:33755 Tue 03 Sep 2019 17:57:49 AEST ]]> A sputum 6-gene signature predicts future exacerbations of poorly controlled asthma https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:36051 Thu 28 Oct 2021 13:04:53 AEDT ]]> Acute stroke imaging research roadmap III imaging selection and outcomes in acute stroke reperfusion clinical trials: consensus recommendations and further research priorities https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:25015 Thu 28 Oct 2021 13:02:55 AEDT ]]> Acute stroke imaging research roadmap II https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:19652 12 months, with the final meeting occurring during the Stroke Treatment Academy Industry Roundtable (STAIR) on March 9 to 10, 2013, in Washington, DC. This process brought together vascular neurologists, neuroradiologists, neuroimaging research scientists, members of the National Institute of Neurological Disorders and Stroke, industry representatives, and members of the US Food and Drug Administration to discuss stroke imaging research priorities, especially in the light of the recent negative results of acute stroke clinical trials that tested the concept of penumbral imaging selection. The goal of this process was to propose a research roadmap for the next 5 years. STIR recommendations include (1) the use of standard terminology, aligned with the National Institute of Neurological Disorders and Stroke Common Data Elements. ; (2) a standardized imaging assessment of revascularization in acute ischemic stroke trials, including a modified Treatment In Cerebral Ischemia (mTICI) score. ; (3) a standardized process to assess whether ischemic core and penumbral imaging methods meet the requirements to be considered as an acceptable selection tool in acute ischemic stroke trials. ; (4) the characteristics of a clinical and imaging data repository to facilitate the development and testing process described in recommendation no. 3. ; (5) the optimal study design for a clinical trial to evaluate whether advanced imaging adds value in selecting acute ischemic stroke patients for revascularization therapy. ; (6) the structure of a stroke neuroimaging network to implement and coordinate the recommendations listed above. All of these recommendations pertain to research, not to clinical care.]]> Thu 28 May 2020 06:30:04 AEST ]]> A programme for reducing smoking in pre-operative surgical patients: randomised controlled trial https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:634 Thu 25 Jul 2013 09:10:35 AEST ]]> Effects of intensive blood pressure lowering on cerebral ischaemia in thrombolysed patients: insights from the ENCHANTED trial https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:51192 150 mm Hg) after thrombolysis treatment for acute ischaemic stroke between March 3, 2012 and April 30, 2018. Methods: All available brain imaging were analysed centrally by expert readers. Log-linear regression was used to determine the effects of intensive blood pressure lowering on the size of cerebral infarction, with adjustment for potential confounders. The primary analysis pertained to follow-up computerised tomography (CT) scans done between 24 and 36 h. Sensitivity analysis were undertaken in patients with only a follow-up magnetic resonance imaging (MRI) and either MRI or CT at 24–36 h, and in patients with any brain imaging done at any time during follow-up. This trial is registered with ClinicalTrials.gov, number NCT01422616. Findings: There were 1477 (67.3%) patients (mean age 67.7 [12.1] y; male 60%, Asian 65%) with available follow-up brain imaging for analysis, including 635 patients with a CT done at 24–36 h. Mean achieved systolic blood pressures over 1–24 h were 141 mm Hg and 149 mm Hg in the intensive group and guideline group, respectively. There was no effect of intensive blood pressure lowering on the median size (ml) of cerebral infarction on follow-up CT at 24–36 h (0.3 [IQR 0.0–16.6] in the intensive group and 0.9 [0.0–12.5] in the guideline group; log Δmean −0.17, 95% CI −0.78 to 0.43). The results were consistent in sensitivity and subgroup analyses. Interpretation: Intensive blood pressure lowering treatment to a systolic target <140 mm Hg within several hours after the onset of symptoms may not increase the size of cerebral infarction in patients who receive thrombolysis treatment for acute ischaemic stroke of mild to moderate neurological severity. Funding: National Health and Medical Research Council of Australia; UK Stroke Association; UK Dementia Research Institute; Ministry of Health and the National Council for Scientific and Technological Development of Brazil; Ministry for Health, Welfare, and Family Affairs of South Korea; Takeda.]]> Thu 24 Aug 2023 14:38:31 AEST ]]> Lisdexamfetamine for the treatment of acute methamphetamine withdrawal: A pilot feasibility and safety trial https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:52634 Thu 19 Oct 2023 15:11:40 AEDT ]]> Testing the effectiveness of a primary care intervention to improve uptake of colorectal cancer screening: a randomized controlled trial protocol https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:33156 Thu 17 Mar 2022 14:34:24 AEDT ]]> Diagnostic accuracy for self-reported methamphetamine use versus oral fluid test as the reference standard in a methamphetamine-dependent intervention trial population https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:50837 Thu 17 Aug 2023 11:53:14 AEST ]]> Confirmed disability progression as a marker of permanent disability in multiple sclerosis https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:52212 88% likely to be sustained (events with score ˃1.5). Conclusions: Clinicodemographic characteristics of 6-month confirmed disability progression events identify those at high risk of sustained long-term disability. This knowledge will allow future trials to better assess the effect of therapy on long-term disability accrual.]]> Thu 05 Oct 2023 10:22:58 AEDT ]]> Soluble fibre for respiratory health research protocol https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:39264 Thu 02 Jun 2022 11:03:43 AEST ]]> ERS statement: A core outcome set for clinical trials evaluating the management of COPD exacerbations https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:46840 Thu 01 Dec 2022 15:50:25 AEDT ]]> Functional Dyspepsia Treatment Trial (FDTT): a double-blind, randomized, placebo-controlled trial of antidepressants in functional dyspepsia, evaluating symptoms, psychopathology, pathophysiology and pharmacogenetics https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:12764 Sat 24 Mar 2018 08:18:20 AEDT ]]> Forming a national multicentre collaboration to conduct clinical trials: increasing high-quality research in the drug and alcohol field https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:10864 Sat 24 Mar 2018 08:12:52 AEDT ]]> Enrolment of patients to clinical trials in haematological cancer in New South Wales: current status, perceived barriers and opportunities for improvement https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:10183 Sat 24 Mar 2018 08:12:28 AEDT ]]> The second (main) phase of an open, randomised, multicentre study to investigate the effectiveness of an intensive blood pressure reduction in acute cerebral haemorrhage trial (INTERACT2) https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:10798 Sat 24 Mar 2018 08:10:05 AEDT ]]> Improving outcomes after stroke clinical pilot trial protocol https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:10559 Sat 24 Mar 2018 08:08:23 AEDT ]]> Gene therapy researchers' assessments of risks and perceptions of risk acceptability in clinical trials https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:19100 Sat 24 Mar 2018 08:05:15 AEDT ]]> Quality improvements in prostate radiotherapy: outcomes and impact of comprehensive quality assurance during the TROG 03.04 'RADAR' trial https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:18210 Sat 24 Mar 2018 08:04:37 AEDT ]]> Obstacles to participation in randomised cancer clinical trials: a systematic review of the literature https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:21763 Sat 24 Mar 2018 07:53:06 AEDT ]]> Mannitol and outcome in intracerebral hemorrhage: propensity score and multivariable intensive blood pressure reduction in acute cerebral hemorrhage Trial 2 results https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:27092 Sat 24 Mar 2018 07:40:35 AEDT ]]> ImProving outcomes after STroke (POST): results from the randomized clinical pilot trial https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:28656 n = 100) for five-months following hospital discharge after stroke (plus usual care) and compared with usual care (n = 101). Ethical approval was obtained to withhold information about the intervention and primary outcome from participants during the consent process. Results: No significant difference was seen in the proportion of participants with depression in the intervention group (1/88) vs. the control group (3/76) (relative risk 0·29, 95% confidence interval 0·03–2·71) at six-months. No significant differences were seen on Hospital Anxiety Depression Scale (HADS) depression and anxiety sub-scale scores, quality of life, or activities of daily living; however, many (47/100) responded positively to the postcards. Conclusions: Although this simple postcard intervention did not significantly reduce the proportion of participants experiencing high HADS depression sub-scale scores after stroke, it may be an effective way to engage with people after stroke following hospital discharge.]]> Sat 24 Mar 2018 07:37:13 AEDT ]]> Technical quality assurance during the TROG 03.04 RADAR prostate radiotherapy trial: are the results reflected in observed toxicity rates? https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:26791 Sat 24 Mar 2018 07:36:30 AEDT ]]> Dyspepsia in the community: value of a community-based mailed survey to identify potential participants for a randomized clinical trial https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:27822 Sat 24 Mar 2018 07:31:10 AEDT ]]> Low-dose oral cyclophosphamide and methotrexate maintenance for hormone receptor-negative early breast cancer: International Breast Cancer Study Group Trial 22-00 https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:29018 P = .14) and in triple-negative (TN) disease (n = 814; HR, 0.80; 95% CI, 0.60 to 1.06). Patients with TN, node-positive disease had a nonstatistically significant reduced HR (n = 340; HR, 0.72; 95% CI, 0.49 to 1.05). Seventy-one (13%) of 542 patients assigned to CM maintenance did not start CM. Of 473 patients who received at least one CM maintenance dose (including two patients assigned to no CM), 64 (14%) experienced a grade 3 or 4 treatment-related adverse event; elevated serum transaminases was the most frequently reported (7%), followed by leukopenia (2%). Conclusion: CM maintenance did not produce a significant reduction in DFS events in hormone receptor-negative early breast cancer. The trend toward benefit observed in the TN, node-positive subgroup supports additional exploration of this strategy in the TN, higher-risk population.]]> Sat 24 Mar 2018 07:31:09 AEDT ]]> Combination of vancomycin and β-lactam therapy for methicillin-resistant staphylococcus aureus bacteremia: a pilot multicenter randomized controlled trial https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:28522 Staphylococcus aureus (MRSA) bacteremia. Prospective clinical data are lacking. Methods: In this open-label, multicenter, clinical trial, adults with MRSA bacteremia received vancomycin 1.5 g intravenously twice daily and were randomly assigned (1:1) to receive intravenous flucloxacillin 2 g every 6 hours for 7 days (combination group) or no additional therapy (standard therapy group). Participants were stratified by hospital and randomized in permuted blocks of variable size. Randomization codes were kept in sealed, sequentially numbered, opaque envelopes. The primary outcome was the duration of MRSA bacteremia in days. Results: We randomly assigned 60 patients to receive vancomycin (n = 29), or vancomycin plus flucloxacillin (n = 31). The mean duration of bacteremia was 3.00 days in the standard therapy group and 1.94 days in the combination group. According to a negative binomial model, the mean time to resolution of bacteremia in the combination group was 65% (95% confidence interval, 41%-102%; P =. 06) that in the standard therapy group. There was no difference in the secondary end points of 28- and 90-day mortality, metastatic infection, nephrotoxicity, or hepatotoxicity. Conclusions: Combining an antistaphylococcal β-lactam with vancomycin may shorten the duration of MRSA bacteremia. Further trials with a larger sample size and objective clinically relevant end points are warranted. Australian New Zealand Clinical Trials Registry: ACTRN12610000940077 (www.anzctr.org.au).]]> Sat 24 Mar 2018 07:29:19 AEDT ]]> Role of imaging in current acute ischemic stroke workflow for endovascular therapy https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:28334 Sat 24 Mar 2018 07:25:13 AEDT ]]> Results from the partnership for advancement in neuromodulation registry: a 24-month follow-up https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:29789 Sat 24 Mar 2018 07:23:39 AEDT ]]> Adjunctive Garcinia mangostana Linn. (Mangosteen) Pericarp for Schizophrenia: A 24-Week Double-blind, Randomized, Placebo Controlled Efficacy Trial https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:49523 Sat 20 May 2023 12:39:02 AEST ]]> Lymphocyte reconstitution after DMF discontinuation in clinical trial and real-world patients with MS https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:49703 Mon 29 May 2023 13:00:52 AEST ]]> Dietary fibre as a modulator of airway inflammation in asthma (FAIM Study) https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:34174 Mon 23 Sep 2019 10:19:21 AEST ]]> Altering the rehabilitation environment to improve stroke survivor activity: A Phase II trial https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:49585 Mon 22 May 2023 12:22:22 AEST ]]> Modelling the Long-Term Health Outcome and Costs of Thrombectomy in Treating Stroke Patients with Large Ischaemic Core: Comparison between Clinical Trials and Real-World Data https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:53277 Mon 20 Nov 2023 13:02:57 AEDT ]]> Overall survival with [177Lu]Lu-PSMA-617 versus cabazitaxel in metastatic castration-resistant prostate cancer (TheraP): secondary outcomes of a randomised, open-label, phase 2 trial https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:54742 Mon 11 Mar 2024 14:26:03 AEDT ]]> Randomized controlled trial of online interventions for co-occurring depression and hazardous alcohol consumption: Primary outcome results https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:48460 .05) in the number of MoodGYM modules completed between the two groups. Discussion and conclusion: The current trial found no benefit to providing a brief online intervention for hazardous alcohol consumption alongside one for depression among people experiencing these co-occurring disorders. Further, the finding that adding an online intervention for drinking to one for depression led to a small reduction in the number of times the interventions were accessed implies the need for caution when deciding how best to provide online help to those with co-occurring depression and hazardous alcohol consumption. Trial Registration: ClinicalTrials.gov NCT03421080.]]> Fri 17 Mar 2023 12:07:36 AEDT ]]> Results of a survey of cancer patients' willingness to travel to participate in a clinical trial https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:46154 Fri 11 Nov 2022 19:05:54 AEDT ]]> Credentialing of vertebral stereotactic ablative body radiotherapy in a multi-centre trial https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:38954 90% passing 2%/2mm/10% threshold) and ≤ 1 mm positional accuracy at target-cord interface was required. Results: 19 centres were credentialed; 11 had on-site measurement. Delivery devices included linear accelerator, TomoTherapy and CyberKnife systems. Five centres did not achieve 90% gamma passing rate. Of these, three were out of tolerance (OOT) in low (<5Gy) dose regions and > 80% passing rate and deemed acceptable. Two were OOT over the full dose range: one elected not to remeasure; the other also had positional discrepancy greater than 1 mm and repeat measurement with a new plan was in tolerance. The original OOT was attributed to inappropriate MLC constraints. All centres delivered planned target-cord dose gradient within 1 mm. Conclusion: Credentialing measurements for vertebral SABR in a multi-centre trial showed although the majority of centres delivered accurate vertebral SABR, there is high value in independent audit measurements. One centre with inappropriate MLC settings was detected, which may have resulted in delivery of clinically unacceptable vertebral SABR plans.]]> Fri 11 Mar 2022 15:47:13 AEDT ]]> Effectiveness of a clinical practice change intervention in increasing the provision of nicotine dependence treatment in inpatient psychiatric facilities: an implementation trial https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:32885 18 years, N = 4175) over a 19 month period in two inpatient adult psychiatric facilities in New South Wales, Australia. The clinical practice change intervention comprised six key strategies: leadership and consensus, enabling systems and procedures, training and education, information and resources, audit and feedback and an on-site practice change support officer. Systematic medical record audit and segmented logistic regression was used to determine differences in proportions for each nicotine dependence treatment outcome measure between the ‘pre’, ‘during’ and ‘post-intervention’ periods. Results: The prevalence of all five outcome measures increased significantly between the pre and post-intervention periods, including clinician recorded: assessment of patient smoking status (36.43 to 51.95%; adjusted odds ratio [AOR] = 2.39, 99% Confidence Interval [CI]: 1.23 to 4.66); assessment of patient nicotine dependence status (4.74 to 11.04%; AOR = 109.67, 99% CI: 35.35 to 340.22); provision of brief advice to quit (0.85 to 8.81%; AOR = 97.43, 99% CI: 31.03 to 306.30); provision of nicotine replacement therapy (8.06 to 26.25%; AOR = 19.59, 99% CI: 8.17 to 46.94); and provision of nicotine dependence treatment on discharge (8.82 to 13.45%, AOR = 12.36; 99% CI: 6.08 to 25.14). Conclusions: This is the first study to provide evidence that a clinical practice change intervention may increase clinician recorded provision of nicotine dependence treatment in inpatient psychiatric settings. The intervention offers a mechanism for psychiatric facilities to increase the provision of nicotine dependence treatment in accordance with clinical guidelines.]]> Fri 03 Dec 2021 10:34:59 AEDT ]]>