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《Clinical gastroenterology and hepatology》2022,20(5):1112-1121.e4
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《Neuro-Chirurgie》2022,68(3):262-266
BackgroundThe prognosis for patients with recurrent glioblastoma (GBM) is dismal, and the question of repeat surgery at time of recurrence is common. Re-operation in the management of these patients remains controversial, as there is no randomized evidence of benefit. An all-inclusive pragmatic care trial is needed to evaluate the role of repeat resection.Methods3rGBM is a multicenter, pragmatic, prospective, parallel-group randomized care trial, with 1:1 allocation to repeat resection or standard care with no repeat resection. To test the hypothesis that repeat resection can improve overall survival by at least 3 months (from 6 to 9 months), 250 adult patients with prior resection of pathology-proven glioblastoma for whom the attending surgeon believes repeat resection may improve quality survival will be enrolled. A surrogate measure of quality of life, the number of days outside of hospital/nursing/palliative care facility, will also be compared. Centers are invited to participate without financial compensation and without contracts. Clinicians may apply to local authorities to approve an investigator-led in-house trial, using a common protocol, web-based randomization platform, and simple standardized case report forms.DiscussionThe 3rGBM trial is a modern transparent care research framework with no additional risks, tests, or visits other than what patients would encounter in normal care. The burden of proof remains on repeat surgical management of recurrent GBM, because this management has yet to be shown beneficial. The trial is designed to help patients and surgeons manage the uncertainty regarding optimal care.Clinical Trial Registrationhttp://www.clinicaltrials.gov. Unique identifier: NCT04838782. 相似文献
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《Journal of vascular and interventional radiology : JVIR》2020,31(1):25-34
PurposeTo investigate the safety of yttrium-90 radioembolization in combination with checkpoint inhibitor immunotherapy for the treatment of hepatocellular carcinoma (HCC).Materials and MethodsThis single-center retrospective study included 26 consecutive patients with HCC who received checkpoint inhibitor immunotherapy within 90 days of radioembolization from April 2015 to May 2018. Patients had preserved liver function (Child-Pugh scores A–B7) and either advanced HCC due to macrovascular invasion or limited extrahepatic disease (21 patients) or aggressive intermediate stage HCC that resulted in earlier incorporation of systemic immunotherapy (5 patients). Clinical documentation, laboratory results, and imaging results at 1- and 3-month follow-up intervals were reviewed to assess treatment-related adverse events and treatment responses.ResultsThe median follow-up period after radioembolization was 7.8 months (95% confidence interval [CI], 5.6–11.8). There were no early (30-day) mortality or grades 3/4 hepatobiliary or immunotherapy-related toxicities. Delayed grades 3/4 hepatobiliary toxicities (1–3 months) occurred in 2 patients in the setting of HCC disease progression. One patient developed pneumonitis. The median overall survival from first immunotherapy was 17.2 months (95% CI, 10.9–23.4). The median overall survival from first radioembolization was 16.5 months (95% CI, 6.6–26.4). From first radioembolization, time to tumor progression was 5.7 months (95% CI, 4.2–7.2), and progression-free survival was 5.7 months (95% CI, 4.3–7.1).ConclusionsRadioembolization combined with checkpoint inhibitor immunotherapy in cases of HCC appears to be safe and causes limited treatment-related toxicity. Future prospective studies are needed to identify the optimal combination treatment protocols and evaluate the efficacy of combination therapy. 相似文献
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《Vaccine》2016,34(43):5155-5158
BackgroundGrowing conflict and insecurity played a major role in precipitating polio outbreaks in the Horn of Africa and the Middle East. In Angola, the early post-conflict situation was characterized by the presence of many inaccessible zones and districts due to insecurity and poor infrastructure. Partnership with the Angolan Army health service (AAHS) was one of the innovative strategies that the Polio Eradication Initiative (PEI) introduced into the country to support the polio vaccination campaigns in insecure and hard to reach zones.MethodsBefore embarking on creating a partnership with Angolan military it was essential to make high-level advocacy with top military decision makers to engage the leadership in the process for better and sustainable support to the strategy. The principal supports provided by the AAHS were the administration of oral polio vaccine, vitamin A, deworming agents, social mobilization, monitoring campaign quality, and surveillance. Distribution of logistics using military vehicles and helicopters to hard to reach and insecure zones was also part of the support.ResultsUsing this partnership it was possible to reach a significant number of children in insecure and hard to reach areas with polio vaccine and other child survival interventions. The military partnership also contributed in increasing the demand and addressing rejection for the polio vaccine.ConclusionMilitary is a potentially productive force that can be used for any development activities in any country. The Angolan experience has demonstrated that it is possible to form a partnership with the military for basic health intervention activities with little training and investment. 相似文献