Non-Randomized Study Protocols and Methods (Non-eHealth)

An Exploratory Trial of EPI-589 in Amyotrophic Lateral Sclerosis (EPIC-ALS): Protocol for a Multicenter, Open-Labeled, 24-Week, Single-Group Study

Shotaro Haji, Koji Fujita, Ryosuke Oki, Yusuke Osaki, Ryosuke Miyamoto, Hiroyuki Morino, Seiichi Nagano, Naoki Atsuta, Yuki Kanazawa, Yuki Matsumoto, Atsuko Arisawa, Hisashi Kawai, Yasutaka Sato, Satoshi Sakaguchi, Kenta Yagi, Tatsuto Hamatani, Tatsuo Kagimura, Hiroaki Yanagawa, Hideki Mochizuki, Manabu Doyu, Gen Sobue, Masafumi Harada, Yuishin Izumi

JMIR Res Protoc 2023;12:e42032

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An Intervention Program to Reduce Medication-Related Problems Among Polymedicated Home-Dwelling Older Adults (OptiMed): Protocol for a Pre-Post, Multisite, Pilot, and Feasibility Study

Filipa Pereira, Maria dos Anjos Dixe, Sónia Gonçalves Pereira, Carla Meyer-Massetti, Henk Verloo

JMIR Res Protoc 2023;12:e39130

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The Effects of HIV Infection on the Immune Response to Malaria Among Pregnant Women in Kumba, Southwest Cameroon: Protocol for a Cross-sectional Study

Bekindaka Ngemani Obase, Zeukeng Francis, Esemu Livo Forgu, Awanakam Honore, Jude Daiga Bigoga, Dickson S Nsagha

JMIR Res Protoc 2023;12:e38213

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A Prescription Digital Therapeutic to Support Unsupervised Buprenorphine Initiation for Patients With Opioid Use Disorder: Protocol for a Proof-of-Concept Study

Hilary Luderer, Nicole Enman, Robert Gerwien, Stephen Braun, Samantha McStocker, Xiaorui Xiong, Carrington Koebele, Christopher Cannon, Joseph Glass, Yuri Maricich

JMIR Res Protoc 2023;12:e43122

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Physical and Mental Effects of Foot Baths Among Women in Labor: Protocol for a Pre-Post Test Experimental Design

Naoko Hikita, Ritsuko Iso, Kiyoko Mizuhata, Akemi Isoyama, Ayumi Kobayashi, Rika Muroi

JMIR Res Protoc 2023;12:e39985

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A Stepped Health Services Intervention to Improve Care for Mental and Neurological Diseases: Protocol for a Prospective Cohort Trial

Johannes Pollmanns, Karlheinz Großgarten, Julia K Wolff, Hans-Dieter Nolting, Clarissa Graf, Frank Bergmann, Gereon Nelles

JMIR Res Protoc 2023;12:e37569

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Measurement of Vital Signs by Lifelight Software in Comparison to Standard of Care Multisite Development (VISION-MD): Protocol for an Observational Study

Laura Wiffen, Thomas Brown, Annika Brogaard Maczka, Melissa Kapoor, Laurence Pearce, Milan Chauhan, Anoop J Chauhan, Manish Saxena, Lifelight Trials Group

JMIR Res Protoc 2023;12:e41533

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The Predictive Value of A, B, and C-Type Natriuretic Peptides in People at Risk of Heart Disease: Protocol for a Longitudinal Observational Study

Timothy C R Prickett, John F Pearson, Richard W Troughton, Martin A Kennedy, Eric A Espiner

JMIR Res Protoc 2023;12:e37011

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Activating Relatives to Get Involved in Care After Surgery: Protocol for a Prospective Cohort Study

Selma C W Musters, Sani Kreca, Susan van Dieren, Hanneke van der Wal-Huisman, Johannes A Romijn, Wendy Chaboyer, Els J M Nieveen van Dijkum, Anne M Eskes, ARTIS Consortium

JMIR Res Protoc 2023;12:e38028

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Home Automation for Adults With Disability Following an Injury: Protocol for a Social Return on Investment Study

Jenny Cleland, Claire Hutchinson, Patricia A H Williams, Kisani Manuel, Kate Laver

JMIR Res Protoc 2022 (Dec 21); 11(12):e42493

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The Evaluation of a Clinical Decision Support Tool Using Natural Language Processing to Screen Hospitalized Adults for Unhealthy Substance Use: Protocol for a Quasi-Experimental Design

Cara Joyce, Talar W Markossian, Jenna Nikolaides, Elisabeth Ramsey, Hale M Thompson, Juan C Rojas, Brihat Sharma, Dmitriy Dligach, Madeline K Oguss, Richard S Cooper, Majid Afshar

JMIR Res Protoc 2022 (Dec 19); 11(12):e42971

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Exploring Stakeholder Requirements to Enable the Research and Development of Artificial Intelligence Algorithms in a Hospital-Based Generic Infrastructure: Protocol for a Multistep Mixed Methods Study

Lina Weinert, Maximilian Klass, Gerd Schneider, Oliver Heinze

JMIR Res Protoc 2022 (Dec 16); 11(12):e42208

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The Japan Registry for Adult Subjects of Spinal Muscular Atrophy (jREACT-SMA): Protocol for a Longitudinal Observational Study

Kentaro Sahashi, Atsushi Hashizume, Yachiyo Kuwatsuka, Madoka Chinen, Ai Saotome-Nakamura, Masahiko Ando, Masahisa Katsuno

JMIR Res Protoc 2022 (Dec 15); 11(12):e38878

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Clinical Utility of the OmniGraf Biomarker Panel in the Care of Kidney Transplant Recipients (CLARITY): Protocol for a Prospective, Multisite Observational Study

James N Fleming, Timothy Cober, Janelle Hickey, Leslie Stach, Allison Kawano, Amanda Szczepanik, Alicia Watson, Yuka Imamura, Juston Weems, Patricia West-Thielke

JMIR Res Protoc 2022 (Dec 14); 11(12):e41020

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Postoperative Sigmoidoscopy and Biopsy After Elective Endovascular and Open Aortic Surgery for Preventing Mortality by Colonic Ischemia (PSB-Aorta-CI): Protocol for a Prospective Study

Artur Rebelo, Ulrich Ronellenfitsch, Jumber Partsakhashvili, Endres John, Carsten Sekulla, Sebastian Krug, Jonas Rosendahl, Patrick Michl, Jörg Ukkat, Jörg Kleeff

JMIR Res Protoc 2022 (Dec 13); 11(12):e39071

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Nigerian and Ghanaian Young People’s Experiences of Care for Common Mental Disorders in Inner London: Protocol for a Multimethod Investigation

Anthony Isiwele, Carol Rivas, Gillian Stokes

JMIR Res Protoc 2022 (Dec 09); 11(12):e42575

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Integrating Enhanced HIV Pre-exposure Prophylaxis Into a Sexually Transmitted Infection Clinic in Lilongwe: Protocol for a Prospective Cohort Study

Sarah E Rutstein, Mitch Matoga, Jane S Chen, Esther Mathiya, Beatrice Ndalama, Naomi Nyirenda, Naomi Bonongwe, Shyreen Chithambo, Maganizo Chagomerana, Gerald Tegha, Mina C Hosseinipour, Michael E Herce, Edward Jere, Robert G Krysiak, Irving F Hoffman

JMIR Res Protoc 2022 (Dec 05); 11(12):e37395

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Perceived Workload Using Separate (Filtering Facepiece Respirator and Face Shield) and Powered Air-Purifying Respirator and Integrated Lightweight Protective Air-Purifying Respirator: Protocol for an International Multisite Human Factors Randomized Crossover Feasibility Study

Amy Price, Ying Ling Lin, Anna S Levin, Fabio Tumietto, Rodrigo Almeida, Ana Almeida, Caroline Lopes Ciofi-Silva, Luca Fontana, Naila Oliveira, Nicola Francesco Parisi, Giulia Marcelino Mainardi, Luciana Cordeiro, Marco Roselli, Paul Shepherd, Luana Morelli, Najmeh Mehrabi, Kathleen Price, Whitney Chan, Shrinidhy Srinivas, T Kyle Harrison, May Chu, Maria Clara Padoveze, Larry Chu

JMIR Res Protoc 2022 (Dec 01); 11(12):e36549

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Investigating the Effects of Hyperbaric Oxygen Treatment in Necrotizing Soft Tissue Infection With Transcriptomics and Machine Learning (the HBOmic Study): Protocol for a Prospective Cohort Study With Data Validation

Julie Vinkel, Leonor Rib, Alfonso Buil, Morten Hedetoft, Ole Hyldegaard

JMIR Res Protoc 2022 (Nov 25); 11(11):e39252

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A Brief Educational Pre-exposure Prophylaxis Intervention in an Infectious Disease Clinic: Protocol for a Case Series Study

Cynthia Dalton, Judith Cornelius, Bernard Davis

JMIR Res Protoc 2022 (Nov 23); 11(11):e33093

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