5 results on '"Lisa Cushinotto"'
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2. Testing the feasibility of operationalizing a prospective, randomized trial with remote cardiac safety EKG monitoring during a pandemic
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Oneib Khan, Jack L. Martin, David Yaron, Luciano Kapelusznik, Lisa Cushinotto, Judith Spahr, Michael D Ezekowitz, Michele Columbo, and Hans H Liu
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medicine.medical_specialty ,Coronavirus disease 2019 (COVID-19) ,Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ,030204 cardiovascular system & hematology ,EKG monitoring ,Article ,law.invention ,03 medical and health sciences ,Electrocardiography ,0302 clinical medicine ,Randomized controlled trial ,law ,Physiology (medical) ,Pandemic ,medicine ,Humans ,030212 general & internal medicine ,Prospective Studies ,Pandemics ,Cardiotoxicity ,Ekg monitoring ,business.industry ,SARS-CoV-2 ,COVID-19 ,Hydroxychloroquine ,Clinical trial ,Treatment Outcome ,Emergency medicine ,Feasibility Studies ,Cardiology and Cardiovascular Medicine ,business ,Prospective trial ,medicine.drug - Abstract
Background The coronavirus SARS-CoV-2 is highly contagious. Hydroxychloroquine (HCQ) has in vitro activity against SARS-CoV-2. The FDA authorized emergency use of HCQ against COVID-19. HCQ may have dose-related cardiotoxicity. This clinical trial received ethical approval on May 15, 2020, operationalized in June to evaluate a low prophylaxis dose of HCQ (200mg BID) in household contacts of COVID-19-positive patients without physical contact between investigators and participants. It represents the first report of the FDA approved 6-lead EKGs with a smartphone KardiaMobile® 6L application. Methods To reach a sample size of 170, household members were contacted by telephone, emailed consent forms with electronic signature capability, and randomized 2:1 to HCQ or observation for 10 days with follow-up of 14 days. Home saliva PCR tests recorded COVID status on days 1 and 14. Symptoms and 6-lead EKGs were obtained daily. Results Fifty-one participants were randomized with 42 evaluable at day 14. Remote monitoring of 407 EKGs revealed no QTc prolongation or other ECG changes in either group. At time of consent, no participants were symptomatic or COVID+. On days 1 and 14, COVID tests were positive in 4 and 2 in the HCQ group and 4 and 0 in the observation group. No tests converted to positive. There were no deaths or hospitalizations. Conclusions A clinical trial without personal contact, rapidly initiated and operationalized to exclude cardiac toxicity using daily remote 6-lead EKG monitoring, is feasible. Of 407 EKGs from 42 participants, there was no evidence of cardiac toxicity. Clinical trial registration Clinicaltrials.gov: NCT04652648 registration date: December 3, 2020
- Published
- 2021
3. The future is now: our experience starting a remote clinical trial during the beginning of the COVID-19 pandemic
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Michele Columbo, Judith Spahr, Jack L. Martin, Oneib Khan, Hans H Liu, Luciano Kapelusznik, David Yaron, Michael D Ezekowitz, and Lisa Cushinotto
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Medicine (General) ,Prospective clinical trial ,COVID-19 pandemic ,Medicine (miscellaneous) ,Disease ,R5-920 ,Pandemic ,medicine ,Humans ,Infection control ,Pharmacology (medical) ,Confidentiality ,Pandemics ,SARS-CoV-2 ,business.industry ,COVID-19 ,medicine.disease ,Clinical trial ,Treatment Outcome ,Trial management ,Clinical research ,Community health ,Commentary ,Medical emergency ,business ,Inclusion (education) ,Hydroxychloroquine ,Remote ECG monitoring - Abstract
Background The World Health Organization declared the outbreak of SARS-CoV-2 a pandemic on February 11, 2020. This organism causes COVID-19 disease and the rapid rise in cases and geographic spread strained healthcare systems. Clinical research trials were hindered by infection control measures discouraging physical contact and diversion of resources to meet emergent requirements. The need for effective treatment and prevention of COVID-19 prompted an untested investigational response. Trial groups adapted approaches using remote enrolment and consenting, newly developed diagnostic tests, delivery of study medications and devices to participants’ homes, and remote monitoring to ensure investigator/enrollee safety while preserving ethical integrity, confidentiality, and data accuracy. Methods Clinical researchers at our community health system in the USA undertook an outpatient randomized open-label study of hydroxychloroquine (HCQ) prophylaxis versus observation of SARS-CoV-2 infection in household COVID-19 contacts. Designed in March 2020, challenges included COVID-19 infection in the research group, HCQ shortage, and lack of well-established home SARS-CoV-2 tests and remote ECG monitoring protocols in populations naive to these procedures. The study was written, funded, and received ethical committee approval in 4 months and was completed by September 2020 during a period of fluctuating infection rates and conflicting political opinions on HCQ use; results have been published. Singular methodology included the use of a new RNA PCR saliva SARS-CoV-2 home diagnostic test and a remote smartphone-based 6-lead ECG recording system. Results Of 483 households contacted regarding trial participation, 209 (43.3%) did not respond to telephone calls/e-mails and 90 (18.6%) declined; others were not eligible by inclusion or exclusion criteria. Ultimately, 54 individuals were enrolled and 42 completed the study. Numbers were too small to determine the efficacy of HCQ prophylaxis. No serious treatment-related adverse events were encountered. Conclusions Flexibility in design, a multidisciplinary research team, prompt cooperation among research, funding, ethics review groups, and finding innovative study approaches enabled this work. Concerns were balancing study recruitment against unduly influencing individuals anxious for protection from the pandemic and exclusion of groups based on lack of Internet access and technology. An issue to address going forward is establishing research cooperation across community health systems before emergencies develop. Trial registration ClinicalTrials.govNCT04652648. Registered on December 3, 2020.
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- 2021
- Full Text
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4. Abstracts from the 8th International Congress of the Asia Pacific Society of Infection Control (APSIC)
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Nantanit Sutthiruk, Mari Botti, Julie Considine, Andrea Driscoll, Ana Hutchinson, Kumthorn Malathum, Cucunawangsih Cucunawangsih, Veronica Wiwing, Vivien Puspitasari, Rathina Kumar Shanmugakani, Yukihiro Akeda, Takuya Kodera, Pitak Santanirand, Kazunori Tomono, Takayuki Yamanaka, Hiroyuki Moriuchi, Hiroyuki Kitajima, Yuho Horikoshi, Alyona Lavrinenko, Ilya Azizov, Nurlan Tabriz, Margulan Kozhamuratov, Yekatherine Serbo, Dahae Yang, Woonhyoung Lee, Il Kwon Bae, Jae Hyun Lee, Hyukmin Lee, Jung Ok Kim, Seok Hoon Jeong, Kyungwon Lee, Thiba Peremalo, Priya Madhavan, Sharina Hamzah, Leslie Than, Eng Hwa Wong, Mohd Nasir Mohd Desa, Kee Peng Ng, Marionne Geronimo, Maria Fe Tayzon, Maria Jesusa Maño, Angela Chow, Pei-Yun Hon, Mar-Kyaw Win, Brenda Ang, Yee-Sin Leo, Tina See, Rocio Alvarez Marin, Marta Aires de Sousa, Nicolas Kieffer, Patrice Nordmann, Laurent Poirel, Wison Laochareonsuk, Sireekul Petyu, Pawin Wanasitchaiwat, Sutasinee Thana, Chollathip Bunyaphongphan, Woranan Boonsomsuk, Pakpoom Maneepongpermpoon, Silom Jamulitrat, Dorairajan Sureshkumar, Kalyanaraman Supraja, Soundararajan Sharmila, Benny Setiawan, Nicolaski Lumbuun, Haruo Nakayama, Toshiko Ota, Naoko Shirane, Chikako Matuoka, Kentaro Kodama, Masanobu Ohtsuka, Silverose Ann Andales Bacolcol, Melecia Velmonte, Allan Alde, Keithleen Chavez, Arlene Joy Esteban, Aisa Jensen Lee, Tai-Chin Hsieh, null Shio-ShinJean, Huey-Jen Huang, Shu-Ju Huang, Yu-Huan Huang, Pei-Chen Cheng, Su-Fang Yu, Shih-Ming Tsao, Yuan-Ti Lee, Chien-Feng Li, Min-Chi Lu, Nattapol Pruetpongpun, Thana Khawcharoenporn, Pansachee Damronglerd, Nuntra Suwantarat, Anucha Apisarnthanarak, Sasinuch Rutjanawech, Lisa Cushinotto, Patty McBride, Harding Williams, Hans Liu, Phan Thi Hang, Dinh Pham Phuong Anh, Ngai Le, Dung Khu, Lam Nguyen, Roel Beltran Castillo, Ram Gopalakrishnan, Venkatasubramanian Ramasubramanian, Subramanian Sreevidya, Ranganathan Jayapradha, Atsushi Umetsu, Tetsuhiro Noda, Kenyuu Hashimoto, Akihiro Hayashi, Mikie Kabashima, Ursula Jadczak, Knut Elvelund, Marit Johnsen, Bente Borgen, Egil Lingaas, Chia-Hua Mao, Fu-Chieh Chang, Chang-Pan Liu, Ru-Hui Chao, Fu-chieh Chang, Chang-pan Liu, Junpen Pawapotako, Chadanan Prasertpan, Wantanee Malaihuan, Phisit Uirungroj, Chalermpong Saenjum, Teerapat Ouirungrog, Sue Borrell, Pauline Bass, Leon Worth, Zhao Xian-li, Li Xiao-long, Yao Xue-hua, Ren Wei, Zhang Xia Zeng, Man Ying Kong, Christopher Koon Chi Lai, Suet Yi Lee, Ngai Chong Tsang, M. M. O’Donoghue, M. V. Boost, L. K. P. Suen, G. K. Siu, K. W. Mui, C. K. C. Lai, D. N. C. Tsang, Yuka Sato, Mariko Tateishi, Mutsuko Mihashi, Jose Paulo Flor, Marko Bautista, V. Jay De Roxas, Justine Vergara, Nicolo Andrei Añonuevo, Marion Kwek, Jose Acuin, Anna Josea Sanchez, Avel Bathan, Jamilah Binte Jantan, Chua Chor Guek, Eu Chiow Kian, Pampe Anak Pirido, Nur Fadilah Binte Mohd Aron, Leah May Estacio, Francis Alvarez Palana, Michelle Gracia, Nur Syafiqah Binte Shamsuddin, Kersten Timbad Castro, Madonna Baloria, Faezah Binte Adam, Zhang Wei, Poh Bee Fong, Marimuthu Kalisvar, I-Ju Chuang, null Yi-ChunCho, Yu-Fen Chiu, Lung-Chih Chen, Yi-Chun Lin, Shao-Xing Dong, Yi-Chieh Lee, Hui-Chen Kuan, Hsin-Hua Lin, Chia-Chun Chi, Chin-Te Lu, Tang Ya-Fen, Su Li-Hsiang, Liu Jien-Wei, Hsuehlan Chao, PinRu ChangChien, WeiFang Chen, ChungHsu Lai, Lutfe Ara, Syed Mohammad Niaz Mowla, Shaikh Mahmud Kamal Vashkar, Wai Fong Chan, Mabel Yin ChunYau, Karen Kam LingChong, Tze OnLi, Rajwinder Kaur, Ng Po Yan, Gloria Chor Shan Chiu, Christina W. Y. Cheung, Patricia T. Y. Ching, Radley H. C. Ching, Conita H. S. Lam, C. H. Kan, Shirley S. Y. Lee, C. P. Chen, Regina F. Y. Chan, Annie F. Y. Leung, Isadora L. C. Wong, S. S. Lam, Queenie W. L. Chan, Cecilia Chan, Seyed Sadeq Seyed Nematian, Charles John Palenik, Mehrdad Askarian, Nahid Hatam, Itaru Nakamura, Hiroaki Fujita, Ayaka Tsukimori, Takehito Kobayashi, Akihiro Sato, Shinji Fukushima, Tetsuya Matsumoto, V. James De Roxas, V James De Roxas, Nicolo AndreiAñonuevo, Yeng May Ho, Jia Qi Kum, Bee Fong Poh, Kalisvar Marimuthu, Tzu-Yin Liu, Sin-Man Chu, Hui-Zhu Chen, Tun-chieh Chen, Yichun Chen, Ya-Ching Tsao, Sumawadee Skuntaniyom, Pirawadee Tipluy, Sangwan Paengta, Ratchanee wongsaen, Sutthiphun thanomphan, Samettanet Tariyo, Buachan Thongchuea, Pattama Khamfu, Sutthiphan Thanomphan, Wipaporn Natalie Songtaweesin, Suvaporn Anugulruengkit, Rujipat Samransamruajkit, Darintr Sosothikul, Ornanong Tansrijitdee, Anry Nakphunsung, Patchareeyawan Srimuan, Jirachaya Sophonphan, null ThanyaweePuthanakit, Kunyanut Payuk, Wilawan Picheansathian, Nongkran Viseskul, Elizabeth DeNardo, Rachel Leslie, Todd Cartner, Luciana Barbosa, Heinz-Peter Werner, Florian H. H. Brill, Julia Yaeko Kawagoe, Elizabeth De Nardo, Sarah Edmonds- Wilson, David Macinga, Patricia Mays-Suko, Collette Duley, Tran Thi Thuy Hang, Tran Thi My Hanh, Christopher Gordon, Roopa Durairaj, Anusha Rohit, Saujanya Saravanakumar, Jothymani Hemalatha, Ryuichi Hirano, Yuichi Sakamoto, Shoji Yamamoto, Naoki Tachibana, Miho Miura, Fumiyo Hieda, Yoshiro Sakai, Hiroshi Watanabe, Silverose Ann Bacolcol, Keitleen Chavez, Jia-Wei Lim, Aung-Aung Hein, Grace Tin, Vanessa Lim, Huwi-chun Chao, Chiu-Yin Yeh, Mei-feng Lo, Chonlada Piwpong, Songyos Rajborirug, Ploypailin Preechawetchakul, Yada Pruekrattananapa, Tharntip Sangsuwan, Ratchanee Wongsaen, Sungwan Paengta, Napatnun Nilchon, Sutthipun Thanompan, Samattanet Tariyo, Svetlana Kolesnichenko, Yerbol Tishkambayev, Asylkhan Alibecov, Yekaterina Serbo, Youngwon Nam, Jae Hyeon Park, Yun Ji Hong, Taek Soo Kim, Jeong Su Park, Kyoung Un Park, Eui-Chong Kim, Samuel Abumhere Aziegbemhin, Onaiwu Enabulele, Yao-Shen Tung, An-Chi Chen, Shen-Min Huang, Yui-Yein Yang, Li-Hung Wu, Chin-cheng Lin, Tzu Hao Lien, Jia Hao Chang, Yu Shan Huang, Yi Shun Chen, Sasithorn Sirilun, Phisit Ouirungroj, Suwanna Trakulsomboon, Patcharee Prasajak, Maryanne W. N. Kwok, Lady S. H. Ng, Lindy M. T. Wong, Lenina S. L. Poon, Mary K. L. Lai, Holly H. S. Cheng, S. K. Fong, Cindy F. Y. Leung, Jumpei Hasegawa, Hiroki Shirakawa, Sachiko Wakai, Makiko Mieno, Shuji Hatakeyama, Manu Deeudom, Prasit Tharavichitkul, Terrence Chinniah, Jackson Tan, Kavitha Prabu, Sartaj Alam, Aung Kyaw Wynn, Rashidah Ahmad, Amalina Sidek, Dg Azizah Samsuddin, Noraini Ajis, Aliyah Ahmad, Susylawathi Magon, Boon Chu, Jiqiu Kuang, Yan Gao, Shoujun Wang, Yunxiao Hao, Rong Liu, Dongmei Li, Hui Wang, Hisanori Nishio, Hitomi Mori, Yoshiko Morokuma, Takaaki Yamada, Makiko Kiyosuke, Sachie Yasunaga, Kazuhiro Toyoda, Nobuyuki Shimono, Dmitriy Babenko, Anar Turmuhambetova, Antonella Cheşcă, Mark A. Toleman, Lyudmila L. Akhmaltdinova, Mark Albert Magsakay, Angelo Macatibag, Jeannica Kriselle Lerios, Alyona Lavrineko, Dmitry Babenko, Eugene Sheck, Mikhail Edelstein, Lih-Yue Li, Chiung-Wen Chan, Hui-Chuan Pan, Wipa Vanishakije, Warisra Jaikampun, Su-Yin Li, Jian-Feng Li, Yu-Ping Wu, Chiao-Hui Lin, Ping-Chin Chang, Samatanet Tariyo, Suttsiphan Thanompan, Suchada Sukkra, Khalequ Zaman, Sheikh Farzana Zaman, Farzana Zaman, Asma Aziz, Sayeed-Bin Faisal, Magali Traskine, Javier Ruiz-Guiñazú, Dorota Borys, Wendy Wai Yee Lam, May Chow, Lucy Choy, Joseph Kam, Sharifah Azura Salleh, Razila Yacob, Siti Rokiah Yusof, Nordiah Awang Jalil, Maria Lourdes Millan, Jose Lito Acuin, Melecia A. Velmonte, Silverose Ann A. Bacolcol, Ching-I Ting, Sunisa Dissayasriroj, Terrence Rohan Chinniah, Jauharatud DiniSuhaimi, Aizzuddin Mirasin, Nurul Morni, Azizah Samsuddin, Amalina AbuBakar, Amanie Shafiee, Julaini Safar, Leung Annie, Fung Yuk Ling, Lau Edna, Luk Kristine, Satoshi Shinomiya, Kumiko Yamamoto, Kayoko Kjiwara, Mitsuhiro Yamaguchi, Wei Zhang, Bee-Fong Poh, Ming-Chin Chan, Chih-Chien Wang, Huan-Yu Huang, Chiung-Ling Lai, Sajeerat Kosol, Wantana Sakolwirat, Patchanee Paepong, Sawalee Jansanga, Pattarin Jaisamoot, Nuttha Thongnuanual, Chittima Srithong, Somporn Somsakul, Sutima Plongpunth, Mukkapon Punpop, Porntip Malathum, Kulada Peautiwat, Nattawipa boon kirdram, Pimpaporn Klunklin, Geetha Samethadka, Naoko Suzuki, Hitomi Asada, Masao Katayama, Atsushi Komano, Hidehiro Watanabe, Hye Kyung Seo, Joo-Hee Hwang, Myoung Jin Shin, Su Young Kim, Eu Suk Kim, Kyoung-Ho Song, Hong Bin Kim, Lai-Si Un, Choi-Ian Vong, Jocelyn Koh, Sherly Agustinus, Rozita Bte Abu Hassan, Yin Phyu Thinn, Benjamin Ng, Soe Pyae Tun, Su Mon Thi Ha, Xue Xiaoting, Lin Li, Leyland Chuang, Attanayaka Mudiyanselage Chulani Niroshika, Kaluarachchige Anoma Kaluarachchi Perera, Dimingo Kankanamalage Diana Grace Fernando, Bodhipakshage Rohini Hemamala, Chiu-yin Yeh, Hui-Chun Yang, Hsiang-Ju Chiu, Ya-Ling Shih, Yu-Shan Chien, Wan-Yi Lin, Chia-Yun Pan, Ying-Yun Chang, Chiu-Yuch Yea, Ming-Hsien Chu, Li-Chu Lee, Lin Yu-Hsiu, Guo Siao-Pei, Leung Pak-On, Sie Mei-Fe, Chen Jyh-Jou, Chang Yong-Yuan, Shu-Yuan Kuo, Yu-Hsiu Lin, Ji-Sheng Zhang, Pak-On Leung, Mei-Fe Sie, Jyh-Jou Chen, Yan-Ru Chen, Ying-Ling Chen, Chi-Fen Taou, Hsiao-Shan Chen, Hung-Jen Tang, Shin Yu Chen, Yin Yin Chen, Fu Der Wang, Tzu-Ping Shih, Chin-Yu Chen, Su-Jung Chen, Mei-chi Wu, Wan-ju Yang, Mei-ling Chou, Man-Ling Yu, Li-Chu Li, Cheng-Wei Chu, Wen-Hao Tsou, Wen-Chih Wu, Wen-Chi Cheng, Cho-Ching Sun, Shu-Hua Lu, Hsin-Ling Yang, Cheng-Yu Lu, Nitchawan Hirunprapakorn, Sirilux Apivanich, Ttipakorn Pornmee, Chonnikarnt Beowsomboon, Itthaporn Kumkoom, Nongyao Kasatpibal, Jittaporn Chitreecheur, JoAnne D. Whitney, Surasak Saokaew, Kirati Kengkla, Margaret M. Heitkemper, Thanomvong Muntajit, Siriluk Apivanich, Hang Thi Phan, Anh Pham Phuong Dinh, and Tuyet Thi Kim Nguyen
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0301 basic medicine ,Microbiology (medical) ,business.industry ,030106 microbiology ,Public Health, Environmental and Occupational Health ,03 medical and health sciences ,Infectious Diseases ,Asia pacific ,Environmental protection ,International congress ,Medicine ,Infection control ,Pharmacology (medical) ,Socioeconomics ,business - Published
- 2017
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5. Round-robin evaluation of a solid-phase microextraction–gas chromatographic method for reliable determination of trace level ethylene oxide in sterilized medical devices
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Calvin Cummins, Nancy Blaszko, Lisa Cushinotto, Frank Davis, Michael DiCicco, Julie Arinaga, and Thomas I. Harper
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Ethylene Oxide ,Pharmacology ,Detection limit ,Chromatography, Gas ,Chromatography ,Ethylene oxide ,Liquid injection ,Clinical Biochemistry ,Analytical chemistry ,Reproducibility of Results ,Sterilization ,General Medicine ,Sterilization (microbiology) ,Solid-phase microextraction ,Biochemistry ,Analytical Chemistry ,chemistry.chemical_compound ,Equipment and Supplies ,chemistry ,Drug Discovery ,Molecular Biology ,Solid Phase Microextraction ,Disinfectants - Abstract
Medical devices that are sterilized with ethylene oxide (EtO) retain small quantities of EtO residuals, which may cause negative systemic and local irritating effects, and must be accurately quantified to ensure non-toxicity. The goal of this round-robin study is to investigate the capability of a novel solid-phase microextraction-gas chromatographic (SPME-GC) method for trace-level EtO residuals analysis: three independent laboratories conducted a guided experiment using this SPME-GC method, in assessing method performance, ruggedness and the feasibility of SPME fibers. These were satisfactory across the independent laboratories, at the 0.05-5.00 ppm EtO range. This method was then successfully applied to analyze EtO residuals in several sterilized/aerated medical devices of various polymeric composition, reliably detecting and quantifying the trace levels of EtO residuals present ( approximately 0.05 ppm EtO). SPME is a feasible alternative for quantifying trace-level EtO residuals in sterilized medical devices, thereby lowering the limit of quantification (LOQ) by as much as two to three orders of magnitude over the current GC methodology of direct liquid injection.
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- 2008
- Full Text
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