RECULE GONZALEZ, FRANCISCA
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RECULE GONZALEZ, FRANCISCA
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frecule@udd.cl
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57193331909

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2024 2024 2023 2023 2022 2022 2021 2021 2020 2020 2019 2019 2018 2018 2017 2017 2016 2016 2015 2015 0.0 0.0 1.0 1.0 2.0 2.0 3.0 3.0 4.0 4.0 5.0 5.0

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Extranodal Follicular Dendritic Cell Sarcoma Presenting on the Skin

2024 , Rosario Agüero , RECULE GONZALEZ, FRANCISCA , Jaime Pérez , CASTRO MENDEZ, ALEX

Abstract: Follicular dendritic cell sarcoma is a rare intermediate-grade malignancy characterized by a proliferation of ovoid to spindle-shaped cells with morphologic and immunophenotypic features similar to normal follicular dendritic cells. It may develop in lymph nodes or extranodal sites. Its presentation in extranodal tissues is a diagnostic challenge. It requires a high index of suspicion because follicular dendritic cell markers are not included in the routine immunohistochemical panels used for differential diagnosis. In an extensive review of the English literature, we found 3 cases of follicular dendritic cell sarcoma developing on the skin. We report a case of a primary cutaneous follicular dendritic cell sarcoma in a 28-year-old man, which presented as a 6-mm skin-colored nodule on the right forearm. We describe the morphologic and immunohistochemical features and a review of the literature.

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The third Intensive Care Bundle with Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial (INTERACT3): an international, stepped wedge cluster randomised controlled trial

2023 , Lu Ma , Xin Hu , Lili Song , Xiaoying Chen , Menglu Ouyang , Laurent Billot , Qiang Li , Alejandra Malavera , Xi Li , Paula Muñoz-Venturelli , Asita de Silva , Nguyen Huy Thang , Kolawole W Wahab , Jeyaraj D Pandian , Mohammad Wasay , Octavio M Pontes-Neto , Carlos Abanto , Antonio Arauz , Haiping Shi , Guanghai Tang , Sheng Zhu , Xiaochun She , Leibo Liu , Yuki Sakamoto , Shoujiang You , Qiao Han , Bernard Crutzen , Emily Cheung , Yunke Li , Xia Wang , Chen Chen , Feifeng Liu , Yang Zhao , Hao Li , Yi Liu , Yan Jiang , Lei Chen , Bo Wu , Ming Liu , Jianguo Xu , Chao You , Craig S Anderson , Thompson Robinson , J. Jaime Miranda , Craig S. Anderson , Chao You , Lili Song , Adrian Parry-Jones , Nikola Sprigg , Sophie Durrans , Caroline Harris , Ann Bamford , Olivia Smith , Robert Herbert , Christopher Chen , William Whiteley , Rong Hu , Laurent Billot , Qiang Li , Jayanthi Mysore , Xin Hu , Yao Zhang , Feifeng Liu , Yuki Sakamoto , Shoujiang You , Qiao Han , Bernard Crutzen , Yunke Li , Emily Cheung , Stephen Jan , Hueiming Liu , Menglu Ouyang , Lingli Sun , Honglin Chu , Anila Anjum , Francisca Gonzalez Mc Cawley , Alejandra Del Rio , Bruna Rimoli , Rodrigo Cerantola , Thanushanthan Jeevarajah , Madhushani Kannangara , Andrene Joseph , Chamath Nanayakkara , Xiaoying Chen , Alejandra Malavera , Chunmiao Zhang , Zhao Yang , Brook Li , Zhuo Meng , Menglu Ouyang , Leibo Liu , Yi Ning , Le Dong , Manuela Armenis , Joyce Lim , Helen Monaghan , Lu Ma , Xin Hu , Xi Li , Rui Luo , Guojuan Cheng , Yilin Dong , Ziqin Liu , Shuihong Wang , Ying Zhang , Jipeng Cheng , Hui Shi , Wenjing Li , Langming Mou , Ping Yi , Chen Chen , Xue Chen , Shalomi Weerawardena , Poornima Ellawala , Enalee Ranasinghe , Chrishmi Rodrigo , Kolawala Wahab , Sunday Adeniyi , Jeyaraj Pandian , Megha Khanna , MUÑOZ VENTURELLI, PAULA ANDREA , RECULE GONZALEZ, FRANCISCA , Francisca Urrutia Goldsack , Mohammad Wasay , Dilshad Begum , Anila Anjum , Octavio Pontes-Neto , Millene Camilo , Francisco Dias , Octavio Vincenzi , Rodrigo Cerantola , Carla Moro , Renata Santos , Nara Texeira , Alexandre Longo , Rafaela Liberato , Sheila Martins , Arthur Pille , Bruna Chwal , Isabel Silva , Natacha Titton , Gustavo Weiss , Daissy Mora , Magda Ouriques , Leonardo Carbonera , Rodrigo Bazan , Gabriel Modolo , Fernanda Winckler , Luana Miranda , Juli Souza , Alexis Rojo , Wilhelm Uslar , Lorena Medel , Javiera Lopez , Diego Herrero , LAVADOS GERMAIN, PABLO MANUEL , Barbara Vargas Latorre , Nathalie Conejan , Tomas Esparza , Patricio Sotomayor , Denisse Wenger , Juan Pablo Gigoux , Aldo Letelier , Lilian Acevedo , Vivianne Moya , Cristian Figueroa , Nicol Vallejos , Nathalie Conejan , Tomas Esparza , Patricio Sotomayor , Rodrigo Guerrero , Mauricio Velasquez , Jose Vallejos , Kimerly Pallauta , Tamara Santibanez , Angelo Queirolo , Andrea Lobos , Yongming Jiang , Weimin Li , Wei Huang , Ke Luo , Gangying Liu , Guanghai Tang , Guang Yang , Hongtao Jiang , Xu Zhang , Hongyan Jing , Sheng Zhu , Bo Pu , Dong Lv , Hui Kang , Qiuping Hu , Xiaochun She , Xiaoming Jiang , Yanli Chen , Shenghua Yang , Jianjun He , Zongping Li , Gang Cheng , Hailin Huang , Xiaoyi Wang , Jianqiong Lin , Minhui Chen , Chenghao Yang , Hao Ding , Yunliang Deng , Fei Luo , Rongjun Zhang , Xiaofeng Wang , Hongbing Zhang , Xiaoliang Yang , Yang Zhang , Chengyi Yang , Yu He , Feng Liu , Rongjie Wang , Yuhui Zhang , Xiaodong Xin , Bin Feng , Wanru Hao , Chang Song , Yun Guo , Dehua Jiang , Jie Chen , Changtong Tang , Hongliang Zhu , Xin Li , Jin Cui , Haidong Xu , Boyang Li , Fusheng Tang , Yuanbin Li , Min Gao , Bo Yang , Xuejun Xu , Bing Deng , Yi Zheng , Yuanhong Ge , Keyu Chen , Yang Liu , Xinshen Li , Tingting Zhong , Jianfeng Xu , Hai Zhang , Jiyue Wang , Jianxin Zhu , Hanyu Sun , Fuhua Yu , Xueguang Zhang , Chao You , Lu Ma , Xin Hu , Jianguo Xu , Xi Li , Mingsen Zhang , Bin Wang , Yiming Ma , Donglin Jiang , Jun Zhou , Cong Liu , Wenhong Nie , Mingguo Li , Tao Tian , Yong Li , Mingfang He , Xiaolong Tu , Zhengjun Wu , Hong Liu , Dongsheng Zhong , Rongcai Jiang , Jian Sun , Ye Tian , Yingsheng Wei , Shuo An , Pingbo Wei , Le Luo , Bin Lin , Gang Liu , Yan Wen , Qiang Cai , Qianxue Chen , Pan Lei , Zhiyang Li , Meifang Zhang , Jiaquan He , Yan Chen , Jun Liu , Xinghai Liu , Junyan Li , Min Chen , Jing Wang , Bingzhi Zhou , Baichun Ye , Jiancheng Zhang , Manyuan Zhang , Xuming Pan , Xiaoxiang Yu , Jian Xu , Qingbao Xiao , Yuefei Wang , Liang Tao , Lin Shi , Niandong Zheng , Guoliang You , Bo Lei , Shu Chen , Honggang Wu , Jin Hu , Jianlan Zhao , Jian Yu , Qiang Yuan , Zhuoying Du , Xielin Tang , Qianke Li , Shenghua Liu , Feilong Yang , Kui Xiao , Chao Luo , Guang Wang , Xudong Che , Zhipeng Teng , Wenwu Wan , Jun Li , Yu Liu , Mingbo Fan , Tao Zhang , Lun Cai , Yuan Ma , Zhifeng Ma , Bin Li , Linlin He , Jinghui Li , Weibing Zhang , Shuxin Zhang , Hongzhen Zhang , Yingguang Dai , Jun Lei , Lei Mao , Yiyang Huang , Zhi Zhou , Ping Chen , Fang Chen , Pan Wei , Tiangui Li , Honglin Chen , Mengfei Zeng , Kejie Mou , Jun Xue , Yong Jiang , Xiaoping Tang , Tao Chen , Yalan Zhang , Yanbing Xu , Yuchen Gu , Lei Chen , Yujun Zhao , Bin Yang , Peng Kuai , Xi Wang , Yuwang Yang , Xueling Hu , Huitian Zhang , Yintao Yang , Weifeng Wang , Junyi Zhang , Wei Cheng , Xiaoxue Zhang , Xiaowen Ma , Qin He , Li Zhang , Rong Gao , Huixiang Liu , Jingwei Ye , Ping Xu , Xin Wu , Yuan Yuan , Peng Zou , Zhen Zhang , Jiyong Cheng , Zhangming Zhou , Yijun Zeng , Zhang Liang , Deming Du , Shui Yu , Yongjun Cao , Shoujiang You , Jiaping Xu , Zhichao Huang , Dongqin Chen , Wenfeng Xiao , Li Zhu , Miao Yuan , Yuhai Wang , Dongliang Shi , Xu Hu , Dingchao Xiang , Like Shi , Hongqin Wang , Liu Yang , Wang Miao , Yiyi Hu , Yuchun Zhao , Xi Hu , Yang Liu , Weiduo Zhou , Chao Sun , Tao Chen , Dong Tang , Kun Yao , Jin You , Shishi Chen , Jianmin Yao , Huanmei Li , Jinmei Liu , Ailin Bai , Yong Yi , Qingshan Deng , Peng Luo , Han Wang , Jingcheng Jiang , Qingwei Yang , Shunpo He , Jun Wang , Yu Chen , Hua He , Yuyang Deng , Zhikai Cao , Xuxia Yi , Jinbiao Luo , Shuang Luo , Min Gong , Li Liu , Xuejun Gao , Jia Liu , Li'e Wu , Jia Zhang , Hongying Sun , Xinhui Li , Lu Jia , Jianbing Wu , Jie Zhang , Huajun Zhang , Chunfu Du , Shun Li , Xiaobin Yang , Jie He , Lei Liao , Gezhi Zhou , Wentao Dong , Yunxiang Chen , Xiaofeng Lin , Xujian Shui , Peng Zhang , Yuan Zhao , Hongli Yang , Wenbin Zhao , Xiaoyi Zhang , Jincao Chen , Qian Wu , Xuan Dai , Baogui Tang , Yinjuan Wang , Tao Liu , Haixia Zhang , Faliang Duan , Ming Luo , Qingfang Jiao , Guoliang Lei , Dong Wang , Chunwang Song , Haopeng Tan , Feng Ye , Xinghu Qin , Xiaolong Liang , Junling Liu , Lang Yang , Jie Yang , Yapeng Lin , Qian Yang , Xuntai Ma , Yinkuang Qi , Baogen Pan , Caixia Jiang , Zhanying Ye , Ce Dong , Xiongfei Yue , Xiaopeng Yang , Tuoheti Maimaitiyiming , Jun Dong , Yonggang Wu , Feng Gao , Deqiang Zhao , Xinghai Zhang , PengJun Wang , Hongbo Jiang , Jianping Li , Wei Zhang , Jing Chen , Haibo Tong , Yonghong Wang , Kaipeng Qiao , Fuyou Guo , Mingchu Zhang , Yan Hu , Mengzhao Feng , Dengpan Song , Yi Zuo , Shangjun Chen , Chao Qian , Baoming Li , Jingku Ma , Sunfu Zhang , Bin Kong , Xingyu Dong , Qiang Li , Sheng Fang , Bin Lu , Yang Li , Zhen Zhang , Yongling Yang , Hong Yu , Huaiyu Sun , Yue Wang , Weimin Wang , Tong Li , Shengli Li , Zhiming Xu , Yongyi Wang , Qiang Dong , Yuping Tang , Heling Chu , Ying Lu , Zhong Wang , Xiaoou Sun , Jianhua Zhao , Shuaifeng Yang , Xiying Qian , Aralikatte Onkarappa Saroja , Ravishankar Naik k , Sandip Chindhi , Nakul Pampaniya , Kurubara Amaresh , Thomas Iype , Dileep R , Reeja Rajan , Praveen Panicker , Rupjyoti Das , Nupur Choudhury , Pankaja Gohain , Jemin Webster , Biyol Pakma , Lalbiak Sangi , Ivy Sebastian , Gaurav Aggrawal , Komal Raj , Deepankshi Rajoura , Sulena Singh , Varun Aggrawal , Amit Narang , Antonio Arauz , Vanesa Cano-Nigenda , Diego López-Mena , Héctor Valdez-Ruvalcaba , Roberto Toledo-Treviño , Reginald Obiako , Sani Abubakar , Oguike Emeka , Balogun Olayemi , Melika Lois , Ibinaiye Philip , Olurishe Comfort O , Njideka Okubadejo , Osigwe Agabi , Oluwadamilola Ojo , Kolawole Wahab , Abiodun Bello , Oyinloye Ibukun , Olufemi Sanayaolu , Sunday Adeniyi , Abdulraheem Jimoh , Mohammad Wasay , Dilshad Begum , Anila Anjum , Shahid Waheed , Dr.Ayeesha Kamal , Raja Farhat Shoaib , Fizza Orooj , Sadaf Majid , Taskeen Zehra , Abdus Salam Khan , Ravi Shanker , Nadir Ali Syed , Nashwa Ahmad , Carlos Abanto , Ana Valencia , Danny Barrientos , Jorge Ramirez , Pilar Calle , Dilum Palliyeguruge , Sumudu Muthucumarana , Shiroma Ratnayaka , Dilhara Ganihiarachchi , Arundathi Bandaranayake , S.D.B Somaratne , Saumya Narayana , Sithara Gallage , Bimsara Senanayake , Udari Samarasiri , Dunya Luke , Mythily Sivapathasundaram , Vithoosan Sahadevan , Amani Rasmi , Yuran Deshaka , Nilukshi Fernando , Aruna Munasinghe , Kapilanga Rathnapriya , A.S Nissanka , Kanchana Karunathilake , Isuru Gayan , Kaminda Wijenayake , Hasitha Gunasekara , Jagath Vidyarathne , Ajantha Keshavaraj , Kanagasabapathy Janarthanan , Arhivalaky Gerald Jeevathasan , Sivaram Sivamainthan , Mathyamuthan John Priyanth , Abirami John Priyanth , Thambippillai Rajendiran , Sanjeewa Alwis , Nushara Gunasekare , Vasundara Liyanarachchi , Athula Dissanayake , Wimalasiri Mewa Uluwattage , Gimhani Ratnayake , Charika Rajinee , Sakura Jayawardana , Janaka Peiris , Ranjith Wicramasinghe , Chamila Fernando , Jessie Abbas , Nethmini Withanage , Makaranda Bandara , Duy Ton Mai , Van Chi Nguyen , Viet Phuong Dao , Xuan Trung Vuong , Tien Dung Nguyen , Trung Hieu Dinh , Ha Quan Phan , Quoc Viet Bui , Dinh Tho Phung , Quang Tho Pham , Dinh Dai Pham , Duc Thuan Do , Phuc Duc Dang , Minh Duc Dang , Dang Hai Nguyen , Thi Phuong Nga Nguyen , Quoc Huy Nguyen , Quoc Dai Pham , Quoc Vinh Chau , Vinh Thy Van Tai , Tran Vinh Le , Cong Tri Le , Ha Mai Khuong Tran , Huu Khanh Nguyen , Hoang Minh Thao Ngyen , Duc Chien Vo , Thai My Phuong Nguyen , Trung Thanh Tran , Thi Hanh Vi Vo , Hao Nhien Cao , Ba Thang Nguyen , Thi Ngoc Suong Le , Thien Duc La , Chi Duc Pham , Huy Thai

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Lupus eritematoso sistémico buloso: Una manifestación infrecuente en población pediátrica

2021 , María Trinidad Hasbún Z. , ROLLAN MARZOLO, MARIA PAZ , Ximena Chaparro R. , Cecilia Fischer S. , Adriana Castrillón V. , Sergio Gonzalez B. , RECULE GONZALEZ, FRANCISCA

El lupus eritematoso sistémico buloso (LESB) es una enfermedad ampollar subepidérmica autoinmune secundaria a la presencia de autoanticuerpos contra el colágeno VII de la membrana basal. Es considerada una variante de lupus eritematoso sistémico (LES), siendo infrecuente en la población pediátrica.Objetivo: Describir caso de paciente pediátrica con erupción ampollar compatible con LESB.Caso Clínico: Paciente de sexo femenino de 16 años de ascendencia mapuche, con antecedentes de LES diagnosticado a los 10 años de edad, en tratamiento. Consultó por erupción vesiculobulosa generalizada de 6 semanas de evolución, sin sintomatología sistémica. Se realizó biopsia para estudio histológico e inmunofluorescencia directa (IFD), confirmándose el diagnóstico de LESB. La paciente respondió favorablemente al tratamiento con dapsona en dosis de 100 mg/día (asociado a su tratamiento de base), sin nuevas reactivaciones a 8 años de seguimiento.Conclusión: El LESB es una manifestación infrecuente de LES. Aunque la clínica es similar a la de otras dermatosis ampollares, la correlación entre la presencia de LES, los hallazgos histopatológicos y de IFD permiten confirmar el diagnóstico. Si bien se ha reportado mayor riesgo de LES en población de ascendencia indígena, faltan estudios respecto a la asociación de LESB en esta etnia.

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Reliability of Hand-Held Transcranial Doppler with M-mode Ultrasound in Middle Cerebral Artery Measurement

2017 , MUÑOZ VENTURELLI, PAULA ANDREA , BRUNSER, ALEJANDRO , Javier Gaete , Sergio Illanes , Javiera López , OLAVARRIA IANISZEWSKY, VERONICA VIVIANA , Andrés Reccius , Pablo Brinck , RECULE GONZALEZ, FRANCISCA , Gabriel Cavada , Pablo M. Lavados

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Seasonal trend of cervical artery dissection in a Chilean cohort

2019 , RECULE GONZALEZ, FRANCISCA , MAZZON AGURTO, ENRICO , DIAZ TAPIA, VIOLETA DEL CARMEN , Rocha, Diego , BRUNSER RABOVICH, ALEJANDRO MICHEL , De La Barra, Camila , Zuniga, Paulo , Dominga Garcia, Maria , Gabriel Cavada , MUÑOZ VENTURELLI, PAULA ANDREA , Zeballos, Shirley , Charaf, Yusef

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Unusual Clinical Presentations of Malignant Melanoma: A Review of Clinical and Histologic Features with Special Emphasis on Dermatoscopic Findings

2018 , CABRERA MORAGA, RAUL ALEJANDRO , Francisca Recule

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Stroke in Latin America: Systematic review of incidence, prevalence, and case-fatality in 1997–2021

2023 , Carlos Delfino Carvalho Pinheiro , Marilaura Nuñez , Claudia Asenjo-Lobos , RECULE GONZALEZ, FRANCISCA , Amy Riviotta , Francisca Urrutia , LAVADOS GERMAIN, PABLO MANUEL , Craig S. Anderson , MUÑOZ VENTURELLI, PAULA ANDREA

Background: Stroke is a major global cause of death and disability. Most strokes occur in populations of low-middle-income country (LMIC); therefore, the subsequent disease burden is greater than in populations of high-income countries. Few epidemiological data exist for stroke in Latin America, composed primarily of LMIC. Aims: To determine epidemiological measures of incidence, prevalence, and 1-month case-fatality for stroke in Latin America/Caribbean (LAC) during 1997–2021. Summary of review: A structured search was conducted to identify relevant references from MEDLINE, WOS, and LILACS databases for prospective observational and cross-sectional studies in LAC populations from January 1997 to December 2021. A total of 9242 records were screened and 12 selected for analysis, seven incidence studies and five prevalence studies. Case-fatality was reported in six articles. Sub-group analysis by age, sex, and income countries was performed. A narrative synthesis of the findings was performed. Meta-analysis was performed using random-effect model to obtain pooled estimates with 95% confidence intervals (CIs). Studies quality was assessed according to the risk of bias criteria described in the Joanna Briggs Institute’s guide. The overall crude annual incidence rate of first-ever stroke in LAC was 119.0 (95% CI = 95.9–142.1)/100,000 people (with high heterogeneity between studies ( I2 = 98.1%)). The overall crude prevalence was 3060 (95% CI: 95.9–142.1)/100,000 people (with high heterogeneity between studies ( I2 = 98.8%)). The overall case-fatality at 1 month after the first stroke was 21.1% (95% CI = 18.6–23.7) ( I2 = 49.40%). Conclusion: This review contributes to our understanding regarding the burden caused by stroke in LAC. More studies with comparable designs are needed to generate reliable data and should include both standardized criteria, such as the World Health Organization clinical criteria and updated standard methods of case assurance, data collection, and reporting.

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Implementation of Low-Intensity Thrombolysis Monitoring Care in Routine Practice: Process Evaluation of the Optimal Post rtPA-IV Monitoring in Acute Ischemic Stroke Study in the USA

2024 , Menglu Ouyang , Francisca González , Michelle Montalbano , April Pruski , Stephen Jan , Xia Wang , Brenda Johnson , Debbie V. Summers , Pooja Khatri , Alejandra Malavera , Michael Iacobelli , Roland Faigle , MUÑOZ VENTURELLI, PAULA ANDREA , Francisca Urrutia Goldsack , Diana Day , Thompson G. Robinson , Alice C. Durham , Ahtasam Ebraimo , Lili Song , Yi Sui , Wan Asyraf Wan Zaidi , Richard I. Lindley , Candice Delcourt , Victor Cruz Urrutia , Craig S. Anderson , Hueiming Liu

<b><i>Introduction:</i></b> The ongoing OPTIMISTmain study, an international, multicenter, stepped-wedge cluster randomized trial, aims to determine effectiveness and safety of low-intensity versus standard monitoring in thrombolysis-treated patients with mild-to-moderate acute ischemic stroke (AIS). An embedded process evaluation explored integration and impact of the intervention on care processes at participating US sites. <b><i>Methods:</i></b> A mixed-methods approach with quantitative and qualitative data was collected between September 2021 and November 2022. Implementer surveys were undertaken at pre- and post-intervention phases to understand the perceptions of low-intensity monitoring strategy. A sample of stroke care nurses were invited to participate in semi-structured interviews at an early stage of post-intervention. Qualitative data were analyzed deductively using the normalization process theory; quantitative data were tabulated. <b><i>Results:</i></b> Interviews with 21 nurses at 8 hospitals have shown low-intensity monitoring was well accepted as there were less time constraints and reduced workload for each patient. There were initial safety concerns over missing deteriorating patients and difficulties in changing established routines. Proper training, education, and communication, and changing the habits and culture of care, were key elements to successfully adopting the new monitoring care into routine practice. Similar results were found in the post-intervention survey (42 nurses from 13 hospitals). Nurses reported time being freed up to provide patient education (56%), daily living care (50%), early mobilization (26%), mood/cognition assessment (44%), and other aspects (i.e., communication, family support). <b><i>Conclusions:</i></b> Low-intensity monitoring for patients with mild-to-moderate AIS, facilitated by appropriate education and organizational support, appears feasible and acceptable at US hospitals.

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Inadequate response to antiplatelet therapy in Sneddon's syndrome. Time to re-evaluate management recommendations?

2024 , Cristóbal Lecaros , Gabriela Coulon , RECULE GONZALEZ, FRANCISCA , CASTRO MENDEZ, ALEX , Constanza Del Puerto

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The main Optimal Post rTpa-Iv Monitoring in Ischemic Stroke Trial (OPTIMISTmain): Protocol for a Pragmatic, Stepped Wedge, Cluster Randomized Controlled Trial

2023 , Menglu Ouyang , Roland Faigle , Xia Wang , Brenda Johnson , Debbie Summers , Pooja Khatri , Laurent Billot , Hueiming Liu , Alejandra Malavera , MUÑOZ VENTURELLI, PAULA ANDREA , RECULE GONZALEZ, FRANCISCA , Francisca Urrutia , Diana Day , Lili Song , Yi Sui , Candice Delcourt , Thompson Robinson , Alice C. Durham , Ahtasam Ebraimo , Wan Asyraf Wan Zaidi , Stephen Jan , Richard I. Lindley , Victor C. Urrutia , Craig S. Anderson

Introduction: Careful monitoring of patients who receive intravenous thrombolysis (IVT) for acute ischemic stroke (AIS) is resource-intensive, and potentially less relevant in those with mild degrees of neurological impairment who are at low risk of symptomatic intracerebral hemorrhage (sICH) and other complications. Methods: OPTIMISTmain is an international, multicenter, prospective, stepped wedge, cluster randomized, blinded outcome assessed trial aims to determine whether a less-intensity monitoring protocol is at least as effective, safe, and efficient as standard post-IVT monitoring in patients with mild deficits post-AIS. Clinically stable adult patients with mild AIS (defined by a NIHSS &lt;10) who do not require intensive care within 2 h post-IVT are recruited at hospitals in Australia, Chile, China, Malaysia, Mexico, UK, USA, and Vietnam. An average of 15 patients recruited per period (overall 60 patient participants) at 120 sites for a total of 7,200 IVT-treated AIS patients will provide 90% power (one-sided α 0.025). The initiation of eligible hospitals is based on a rolling process whenever ready, stratified by country. Hospitals are randomly allocated using permuted blocks into 3 sequences of implementation, stratified by country and the projected number of patients to be recruited over 12 months. These sequences have four periods that dictate the order in which they are to switch from control (usual care) to intervention (implementation of low intensity monitoring protocol) to different clusters of patients in a stepped manner. Compared to standard monitoring, the low-intensity monitoring protocol includes assessments of neurological and vital signs every 15 min for 2 h, 2 hourly (vs. every 30 min) for 8 h, and 4 hourly (vs. every 1 h) until 24 h, post-IVT. The primary outcome measure is functional recovery, defined by the modified Rankin scale (mRS) at 90 days, a seven-point ordinal scale (0 [no residual symptom] to 6 [death]). Secondary outcomes include death or dependency, length of hospital stay, and health-related quality of life, sICH, and serious adverse events. Conclusion: OPTIMISTmain will provide level I evidence for the safety and effectiveness of a low-intensity post-IVT monitoring protocol in patients with mild severity of AIS.

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