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	<title>JMIR Research Protocols</title>
			<updated>2024-12-31T14:00:04-05:00</updated>
	
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		<name>JMIR Publications</name>
				<email>editor@jmir.org</email>
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    	<subtitle>JMIR Res Protoc publishes research protocols, current and ongoing trials, and grant proposals in all areas of medicine (with an initial focus on ehealth/mhealth). Publish your work in this journal to let others know what you are working on, to facilitate collaboration and/or recruitment, to avoid duplication of efforts, to create a citable record of a research design idea, and to aid systematic reviewers in compiling evidence. Research protocols or grant proposals that are funded and have undergone peer-review will receive an expedited review if you upload peer-review reports as supplementary files.</subtitle>



	<entry>
		<id> https://www.researchprotocols.org/2026/1/e89435 </id>
		<title>Service Robots as Work Support for Health Personnel in Long-Term Care: Protocol for a Scoping Review</title>
		<updated>2026-07-08T16:00:03-04:00</updated>

					<author>
				<name>Diego Losada-Floriano</name>
			</author>
					<author>
				<name>Elin Thygesen</name>
			</author>
					<author>
				<name>Filippo Sanfilippo</name>
			</author>
					<author>
				<name>Michael Rygaard Hansen</name>
			</author>
					<author>
				<name>Mariann Fossum</name>
			</author>
				<link rel="alternate" href="https://www.researchprotocols.org/2026/1/e89435" />
					<summary type="html" xml:base="https://www.researchprotocols.org/2026/1/e89435">&lt;strong&gt;Background:&lt;/strong&gt; Demographic shifts are increasing the global demand for long-term care services, coinciding with a worldwide shortage of health care personnel. Service robots, designed to perform tasks in both professional and personal use, are perceived as a potential solution to alleviate health care personnel’s workload and enhance the quality of care. However, the existing literature is fragmented and heterogeneous, with a limited emphasis on the role of service robots in supporting residents rather than health care personnel. Furthermore, there is a lack of consistent definitions of service robotic technologies and a scarcity of studies on implementation models and frameworks. &lt;strong&gt;Objective:&lt;/strong&gt; This scoping review aims to map and synthesize evidence regarding the implementation of service robots as work support for health care personnel in long-term care settings. &lt;strong&gt;Methods:&lt;/strong&gt; A comprehensive 3-step search will be conducted in Embase, MEDLINE, APA PsycInfo, CENTRAL, Scopus, and CINAHL, along with gray literature databases and institutional repositories. Eligible sources encompass empirical studies and gray literature involving service robots, health care personnel, residents aged 65 years or older, and stakeholders such as informal caregivers within institutional long-term care. Exclusions apply to studies on home care, medical or industrial robots, and nonrobotic technologies. Data will be extracted and analyzed using the Joanna Briggs Institute methodology, with findings presented in tables, diagrams, and narrative summaries to identify gaps and inform future research and implementation strategies. &lt;strong&gt;Results:&lt;/strong&gt; The project has been funded for a 4-year period starting in April 2025. This protocol was developed in October 2025 and subsequently registered in November 2025. A comprehensive search strategy was formulated and completely conducted on October 24, 2025. The screening of 4884 titles and abstracts was completed in December 2025, resulting in the retrieval of 64 (1.3%) full-text articles for eligibility assessment. Subsequent phases, including data extraction, analysis, evidence synthesis, and presentation of results, will be conducted sequentially. The scoping review is expected to be finalized by June 2026. &lt;strong&gt;Conclusions:&lt;/strong&gt; This scoping review is expected to delineate the extent and characteristics of the existing evidence on service robots as work support for health personnel in long-term care settings. It will highlight the key reported outcomes and challenges encountered in implementation studies, as well as the theoretical frameworks, models, and concepts applied to address these issues. &lt;strong&gt;Trial Registration:&lt;/strong&gt; Open Science Framework QWK58; https://osf.io/qwk58/ </summary>
		
        
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		<published>2026-07-08T16:00:03-04:00</published>
	</entry>
	<entry>
		<id> https://www.researchprotocols.org/2026/1/e97614 </id>
		<title>My Voice Library: Protocol for Developing Audio and Visual Datasets to Enable Personalized Real-Time Communication for People With Dysarthria</title>
		<updated>2026-07-08T15:30:19-04:00</updated>

					<author>
				<name>Petra Karlsson</name>
			</author>
					<author>
				<name>Andrea Bandini</name>
			</author>
					<author>
				<name>Michelle McInerney</name>
			</author>
					<author>
				<name>Hayley Smithers-Sheedy</name>
			</author>
					<author>
				<name>Annemarie Murphy</name>
			</author>
					<author>
				<name>Maria Dalmon</name>
			</author>
					<author>
				<name>Alistair McEwan</name>
			</author>
					<author>
				<name>Silvia Orlandi</name>
			</author>
				<link rel="alternate" href="https://www.researchprotocols.org/2026/1/e97614" />
					<summary type="html" xml:base="https://www.researchprotocols.org/2026/1/e97614">Background: Communication is a human right; despite this, children with cerebral palsy and dysarthria experience constraints due to their physical disability, affecting their opportunity to reach their full potential and ability to fully participate in play, school, and socializing. For many, their challenge to produce clear speech that can be understood is interpreted by others as an intellectual impairment. Children with moderate-severe speech impairments such as dysarthria often rely on technology solutions, which can translate text or symbols to speech manually or using a single binary switch, scanning hierarchical switch‑access menus. This is time-consuming, arduous, and 15 to 20 times slower than normal speech. Technology innovations, developed via high-quality datasets of audio-video samples of dysarthric speech, hold the key to build personalized speech-recognition algorithms that allow us to bridge this gap. Objective: My Voice Library is a repository of high-quality audio and visual datasets of children living in Australia with cerebral palsy who have dysarthria. The children are presented with gamified modules based on words and sentences from the Frenchay Dysarthria Assessment 2 to allow speech and language therapists, engineers. and programmers to develop personalized speech-recognition approaches to enable personalized real-time communication. Methods: Our ethics and consenting process enables participants (8-18 y) to choose if they want their information to be used for personalized research in addition to general research. The study has been approved by the University of Sydney’s Human Research Ethics Committee (2023/263). Caregivers of the participants provide written informed consent. The results will be disseminated through contributions to international conferences and scientific journals, and they will also be included in students’ theses. Results: The National Health and Medical Research Council funded the study in April 2021. Data collection commenced in March 2024 and will continue until 99 participants have been recruited, after which the database will remain active. As of April 2026, thirteen of 99 participants have been recruited. Preliminary data analysis commenced in 2026. The results from the preliminary analysis are expected to be published in 2027, with full results to be published once 99 participants have been successfully recruited. Conclusions: My Voice Library embeds high-quality voice and video data assessments through gamified modules based on the Frenchay Dysarthria Assessment 2 and was designed in partnership with an active patient and a public involvement advisory group. My Voice Library and its associated information governance will facilitate the research use of real-world data where ethical approval and consent are given. My Voice Library enables the collection of voice data in controlled yet naturalistic environments for children, enhancing the clinical relevance and quality of the dataset. The modular and gamified design promotes sustained participant engagement, reduces fatigue, and increases the quantity and diversity of data collected. International Registered Report Identifier (IRRID): DERR1-10.2196/97614</summary>
		
        
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		<published>2026-07-08T15:30:19-04:00</published>
	</entry>
	<entry>
		<id> https://www.researchprotocols.org/2026/1/e95287 </id>
		<title>Conceptualization, Operationalization, and Measurement of Adherence to Patient-Facing Digital Health Applications: Protocol for a Scoping Review</title>
		<updated>2026-07-08T15:00:28-04:00</updated>

					<author>
				<name>Ludovico Cavallaro</name>
			</author>
					<author>
				<name>Philipp Graf</name>
			</author>
					<author>
				<name>Josephine Verona Konrad</name>
			</author>
					<author>
				<name>Julia Zielke</name>
			</author>
					<author>
				<name>Jan C Zoellick</name>
			</author>
					<author>
				<name>Danielly de Paula</name>
			</author>
					<author>
				<name>Ariel Dora Stern</name>
			</author>
				<link rel="alternate" href="https://www.researchprotocols.org/2026/1/e95287" />
					<summary type="html" xml:base="https://www.researchprotocols.org/2026/1/e95287">Background: Medical adherence is traditionally defined as the extent to which a person’s behavior corresponds with agreed-upon recommendations from a health care provider. The rapid diffusion of patient-facing digital health applications (DHAs) challenges the direct applicability of this framework to software-mediated interventions. Unlike pharmacological treatments, DHAs automatically generate detailed usage data but lack a broadly accepted standard for determining which specific data points and usage patterns actually constitute “adequate” use across a broad variety of medical indications and population groups. In parallel, DHAs are becoming increasingly embedded in formal regulatory and reimbursement pathways. A notable example is Germany, where recent reforms plan to link at least 20% of reimbursement for —formally regulated and reimbursed DHAs—to performance-related indicators that implicitly operationalize adherence as a determinant of reimbursable performance. Despite this growing policy relevance, adherence in patient-facing DHAs remains conceptually fragmented and methodologically heterogeneous. Objective: This scoping review aims to map how adherence is conceptualized, operationalized, and measured in the context of patient-facing DHAs, and to explore whether these approaches differ between applications embedded within formal regulatory and/or reimbursement frameworks and those operating outside such settings. Methods: This scoping review follows the Joanna Briggs Institute methodology and will be reported in accordance with the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines. PubMed (MEDLINE), Scopus, and Web of Science will be searched for scientific literature published between 2020 and 2025, inclusive. Machine learning–assisted title and abstract screening will be performed using ASReview, following a sampling-based stopping criterion. Three independent reviewers will conduct screening and data extraction. Relevant gray literature will be identified through targeted searches. Results: Database searches identified 15,403 records (5469 from PubMed/MEDLINE, 6198 from Scopus, and 3736 from Web of Science), which were reduced to 7052 unique records after automated deduplication using Zotero (Corporation for Digital Scholarship). The full results are intended to be submitted to a peer-reviewed journal by the end of 2026. Conclusions: Conducted as part of the DEKODE ) project funded by the German Federal Joint Committee’s Innovation Fund, this review contributes to the development of a conceptual and empirical adherence framework for patient-facing DHAs. Although DEKODE is primarily oriented toward the German context, this review applies no geographical restrictions, reflecting the value of establishing a broad evidence base before narrowing the focus to country-specific settings and rendering findings relevant for understanding DHA adherence in all geographies. By clarifying how adherence is currently conceptualized, operationalized, and measured, the review will promote more consistent and context-specific generation and interpretation of adherence-related evidence and support evidence-based policy discussions, international harmonization of evidence standards for DHAs, and health economic evaluations in digital health. Trial Registration: OSF Registries 10.17605/OSF.IO/2WZGR; https://doi.org/10.17605/OSF.IO/2WZGR International Registered Report Identifier (IRRID): PRR1-10.2196/95287</summary>
		
        
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		<published>2026-07-08T15:00:28-04:00</published>
	</entry>
	<entry>
		<id> https://www.researchprotocols.org/2026/1/e88548 </id>
		<title>Efficacy of an Ayurvedic Management Protocol on the Rate of Recurrence, Healing and Safety in Parikarthika (Fissure in Ano): Protocol for a Randomized Controlled Trial</title>
		<updated>2026-07-08T15:00:28-04:00</updated>

					<author>
				<name>Indu P P</name>
			</author>
					<author>
				<name>Kalpana Kachare</name>
			</author>
					<author>
				<name>Pratap Shankar K M</name>
			</author>
					<author>
				<name>Binitha P</name>
			</author>
					<author>
				<name>Lisha S</name>
			</author>
					<author>
				<name>Bhagwan Sahai Sharma</name>
			</author>
					<author>
				<name>Thugutla Maheswar</name>
			</author>
					<author>
				<name>Arunabh Tripathi</name>
			</author>
					<author>
				<name>Narayanan Srikanth</name>
			</author>
					<author>
				<name>Rabinarayanan Acharya</name>
			</author>
				<link rel="alternate" href="https://www.researchprotocols.org/2026/1/e88548" />
					<summary type="html" xml:base="https://www.researchprotocols.org/2026/1/e88548">Background: refers to the condition in which the individual experiences a sensation of pain as if the is being cut around with scissors. This condition can be correlated to the fissure in ano. It has been described as an acute superficial break in the continuity of the anoderm, usually in the posterior midline of the anal canal. The incidence of anal fissures is around 1 in 350 adults. Management can be divided into conservative, operative, and adjuvant therapies. The main challenge in the management of fissure in ano is the increased rate of recurrence. Here comes the importance of an alternative therapy which can reduce the recurrence. The recurrence rate of fissure in ano by nonsurgical procedures is 60%, and with the protocol, the expected recurrence rate is 30%. Objective: This study aims to evaluate the efficacy of an management protocol on the rate of recurrence, healing, and safety in (fissure in ano). Methods: A prospective, randomized controlled interventional open-labeled study has been designed to enroll a total of 90 participants from the OPD (Outpatient Department) of National Ayurveda Research Institute for Panchakarma (NARIP), Cheruthuruthy, Kerala. They will be screened for fissure in ano based on physical examination. Participants satisfying the inclusion and exclusion criteria will be randomly allocated to either the trial group (n=45) or the control group (n=45). In the trial group, participants will be managed with and internally and anal infiltration, as well as along with sitz bath in externally. Diltiazem gel will be given for external application in the control group along with sitz bath and internally. The intervention is given for a period of 28 days, and participants are evaluated on 14th, 28th, 56th, 84th, and 112day. The assessment parameters include recurrence rate, treatment efficacy, safety, comparative tolerability, and change in health-related quality of life. Results: This project was funded in June 2024, and the study duration is 36 months. The first participant was enrolled in April 2025; 9 participants were enrolled as of May 2025. The data analysis will be completed by October 2027 and the results are anticipated to be published by December 2027. Conclusions: The study is expected to demonstrate the efficacy of an management protocol on the rate of recurrence, healing, and safety in (fissure in ano). Trial Registration: Clinical Trials Registry - India CTRI/2024/09/073793; https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MTEzMzEx&amp;Enc International Registered Report Identifier (IRRID): DERR1-10.2196/88548</summary>
		
        
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		<published>2026-07-08T15:00:28-04:00</published>
	</entry>
	<entry>
		<id> https://www.researchprotocols.org/2026/1/e85380 </id>
		<title>Educational Interventions for Labor Epidural Awareness in the United States: Protocol for a Scoping Review</title>
		<updated>2026-07-08T11:00:27-04:00</updated>

					<author>
				<name>David Basulto</name>
			</author>
					<author>
				<name>Jacqueline Gamboa</name>
			</author>
					<author>
				<name>Guadalupe Vazquez-Perez</name>
			</author>
					<author>
				<name>Vidhani Goel</name>
			</author>
					<author>
				<name>Roberto Sagaribay</name>
			</author>
					<author>
				<name>Jyoti Desai</name>
			</author>
					<author>
				<name>Kavita Batra</name>
			</author>
				<link rel="alternate" href="https://www.researchprotocols.org/2026/1/e85380" />
					<summary type="html" xml:base="https://www.researchprotocols.org/2026/1/e85380">Background: Labor pain is among the most intense forms of pain, and neuraxial analgesia, including epidural, spinal, and combined spinal-epidural techniques, is considered the gold standard for its management. Despite its effectiveness, persistent misconceptions, cultural barriers, and disparities in awareness contribute to underuse among certain populations. Educational interventions have been developed to address these gaps, yet a comprehensive synthesis of such efforts in the United States is lacking. Objective: This scoping review aims to map the extent, range, and nature of current literature describing educational interventions designed to improve knowledge, awareness, and acceptance of neuraxial analgesia during labor among pregnant women. Methods: Following the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) framework, peer-reviewed studies published in English were identified through PubMed, Embase, and Scopus from inception to August 2025. Eligible studies include those focusing on pregnant individuals eligible for neuraxial analgesia who received educational or counseling interventions during prenatal or perinatal care. Extracted data include study design, intervention type, delivery method, timing, and outcomes of interest, including patient understanding of risks and benefits, awareness of neuraxial analgesia options, acceptance of or preference for neuraxial analgesia, satisfaction with education, and uptake during labor. Data will be synthesized descriptively using summary tables and figures, with a narrative synthesis to categorize interventions by type, timing, and delivery method and identify patterns and gaps across studies. Results: This project was conceived in August 2024, and the protocol was registered in the Open Science Framework in January 2025. The database search was conducted in August 2025. As of protocol submission in October 2025, full-text screening and data extraction are pending and are scheduled for May 2026 to June 2026. Data synthesis and drafting of the results will be completed in September 2026. The manuscript will be submitted in October 2026. Conclusions: This scoping review will map existing educational interventions related to neuraxial labor analgesia and identify gaps in the current literature. The findings may help inform future research and the development of more consistent and accessible patient education approaches. Trial Registration: Open Science Framework osf.io/4enf5; https://osf.io/4enf5/overview International Registered Report Identifier (IRRID): DERR1-10.2196/85380</summary>
		
        
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		<published>2026-07-08T11:00:27-04:00</published>
	</entry>
	<entry>
		<id> https://www.researchprotocols.org/2026/1/e94921 </id>
		<title>Using Electronic Health Records to Enhance Lyme Disease Surveillance: Protocol for the SubLyme Network</title>
		<updated>2026-07-08T10:00:03-04:00</updated>

					<author>
				<name>Annemarie G Hirsch</name>
			</author>
					<author>
				<name>Brian S Schwartz</name>
			</author>
					<author>
				<name>Melissa N Poulsen</name>
			</author>
					<author>
				<name>Anna M Schotthoefer</name>
			</author>
					<author>
				<name>Maria E Sundaram</name>
			</author>
					<author>
				<name>Jacob E Lemieux</name>
			</author>
					<author>
				<name>Linden T Hu</name>
			</author>
					<author>
				<name>Robert P Smith</name>
			</author>
					<author>
				<name>Alexandra M Linz</name>
			</author>
					<author>
				<name>Steph Battan-Wraith</name>
			</author>
					<author>
				<name>Patrick K Mitchell</name>
			</author>
					<author>
				<name>Cassandra A Hathaway</name>
			</author>
					<author>
				<name>Jonathan S Pollak</name>
			</author>
					<author>
				<name>Cara M Nordberg</name>
			</author>
					<author>
				<name>Veronica Burkel</name>
			</author>
					<author>
				<name>Courtney C Nawrocki Luskin</name>
			</author>
					<author>
				<name>Kiersten J Kugeler</name>
			</author>
					<author>
				<name>Alison F Hinckley</name>
			</author>
					<author>
				<name>Sarah A Hook</name>
			</author>
				<link rel="alternate" href="https://www.researchprotocols.org/2026/1/e94921" />
					<summary type="html" xml:base="https://www.researchprotocols.org/2026/1/e94921">&lt;strong&gt;Background:&lt;/strong&gt; Lyme disease is the most common vector-borne illness in the United States. The limitations of traditional surveillance strategies for Lyme disease affect the ability to reliably track its burden and evaluate interventions. The US Centers for Disease Control and Prevention (CDC) established the Surveillance Based Lyme Disease Network (SubLyme) in September 2023 to strengthen Lyme disease surveillance and research using electronic health record (EHR) data. &lt;strong&gt;Objective:&lt;/strong&gt; SubLyme has three primary objectives: (1) to establish and evaluate criteria for identifying Lyme disease cases in EHR data (ie, create computable phenotypes [CPs]) that can be scaled across diverse health systems, (2) to estimate Lyme disease incidence, and (3) to describe Lyme disease incidence by key demographics. Secondary objectives are to develop CPs that distinguish between acute and disseminated Lyme disease, identify clinical manifestations, and support future research efforts. This paper describes SubLyme, its structure, and its methods. &lt;strong&gt;Methods:&lt;/strong&gt; SubLyme includes 5 health systems in 3 US regions with a high risk of Lyme disease: Geisinger, in Pennsylvania; Marshfield Clinic Health System, in Wisconsin; and Mass General Brigham, Tufts Medical Center, and MaineHealth in New England. The network is administered by a coordinating center (Westat) and the US CDC. SubLyme is evaluating the validity of EHR-based CP definitions for Lyme disease. CP performance is assessed by measuring sensitivity, specificity, positive predictive value, and negative predictive value against manually abstracted medical charts. Each site identified a cohort of patients with any Lyme disease element in their EHR (Lyme disease diagnosis code, Lyme disease laboratory test order, and Lyme-appropriate antibiotic order) during 2022 to 2023 and selected 500 charts for manual review as the gold standard against which CP performance was evaluated. SubLyme will use the Lyme disease CPs to generate incidence rates for Lyme disease overall and for various subgroups. &lt;strong&gt;Results:&lt;/strong&gt; SubLyme identified 332,256 patients with at least 1 Lyme disease element in their record from more than 4.6 million patients. Of these patients, 55.6% (n=184,734) were female, 87.9% (n=292,053) were White, and 90.8% (n=301,688) were non-Hispanic. More than half of the patients only had a Lyme-appropriate medication order (n=177,425, 53.4%) and 35.8% (n=118,948) only had a Lyme disease test order. The most common combination was a medication order with a laboratory test order (n=22,926, 6.9%), followed by a combination of a diagnosis, test, and medication order (n=5316, 1.6%). &lt;strong&gt;Conclusions:&lt;/strong&gt; SubLyme is well positioned to advance Lyme disease surveillance using EHR data across multiple health systems. The exploration of new surveillance methods in Lyme disease is critical as disease frequency increases and the geography expands. An EHR-based approach to surveillance has the potential to overcome challenges of current surveillance strategies and to accelerate Lyme disease research. </summary>
		
        
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		<published>2026-07-08T10:00:03-04:00</published>
	</entry>
	<entry>
		<id> https://www.researchprotocols.org/2026/1/e90965 </id>
		<title>Efficacy, Safety, and Mechanism of the Qi-Lian-Xiao-Pi Prescription (WW-1) for Chronic Atrophic Gastritis After Helicobacter Pylori Eradication: Protocol for a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial</title>
		<updated>2026-07-08T09:00:17-04:00</updated>

					<author>
				<name>Wei Bai</name>
			</author>
					<author>
				<name>Guodong Huang</name>
			</author>
					<author>
				<name>Xianjun Rao</name>
			</author>
					<author>
				<name>Hao Li</name>
			</author>
					<author>
				<name>Tingting Zhou</name>
			</author>
					<author>
				<name>Yang Yang</name>
			</author>
					<author>
				<name>Wei Wei</name>
			</author>
				<link rel="alternate" href="https://www.researchprotocols.org/2026/1/e90965" />
					<summary type="html" xml:base="https://www.researchprotocols.org/2026/1/e90965">&lt;strong&gt;Background:&lt;/strong&gt; Chronic atrophic gastritis (CAG) is widely recognized as one of the precancerous lesions of gastric cancer. &lt;i&gt;Helicobacter pylori&lt;/i&gt; is one of the important risk factors for CAG and gastric cancer. However, a large proportion of patients with CAG cannot avoid developing gastric cancer even after eradicating &lt;i&gt;H pylori&lt;/i&gt;. It is necessary to find a safe and effective treatment to suppress this “inflammation-cancer” progression. The Qi-Lian-Xiao-Pi prescription (WW-1), a traditional Chinese medicine (TCM), has been reported to be effective in the treatment of CAG. However, the evidence is subject to methodological limitations. &lt;strong&gt;Objective:&lt;/strong&gt; This study aimed to evaluate the efficacy, safety, and mechanism of the WW-1 in patients with CAG following successful &lt;i&gt;H pylori&lt;/i&gt; eradication. &lt;strong&gt;Methods:&lt;/strong&gt; This study is a rigorous parallel-arm, randomized, placebo-controlled, multicenter, double-blinded trial. A total of 110 eligible participants with a confirmed diagnosis of CAG after &lt;i&gt;H pylori&lt;/i&gt; eradication are being enrolled and randomly assigned in a 1:1 ratio to either the intervention group (WW-1) or the control group (WW-1 placebo). Key eligibility criteria include confirmed CAG by histopathology, documented successful &lt;i&gt;H pylori&lt;/i&gt; eradication, and compliance with predefined inclusion and exclusion criteria. The treatment duration is 24 weeks. Blinded histopathological assessments using the Operative Link on Gastritis Assessment and Operative Link on Gastric Intestinal Metaplasia Assessment staging systems will serve as primary outcomes. Secondary outcomes include improvement rates of gastric mucosal gland atrophy and intestinal metaplasia, as well as TCM syndrome scores. Safety will be assessed through monitoring vital signs, adverse events, blood, urine, and stool tests, liver and kidney function, and electrocardiography. Additionally, gastric mucosal DNA methylation and metagenomic sequencing of digestive tract microbiota (including saliva, tongue coating, gastric, and intestinal samples) will be analyzed to explore potential mechanisms of WW-1. &lt;strong&gt;Results:&lt;/strong&gt; The funding began in November 2023. The study was officially initiated on April 20, 2025, with the enrollment of the first participant. The final study results, including efficacy outcomes, safety profiles, and mechanistic insights, are expected to be released in October 2026 after comprehensive data analysis and verification. &lt;strong&gt;Conclusions:&lt;/strong&gt; This study is designed to determine whether WW-1 can improve CAG by modulating gastric mucosal DNA methylation and the digestive tract microbiota. It represents a prospective clinical trial in TCM that aims to evaluate therapeutic effects on CAG through the regulation of microbiota homeostasis and epigenetic mechanisms. The findings of this study are expected to provide evidence regarding the efficacy and safety of WW-1 and contribute to the development of therapeutic strategies and future drug research for CAG. &lt;strong&gt;Trial Registration:&lt;/strong&gt; </summary>
		
        
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		<published>2026-07-08T09:00:17-04:00</published>
	</entry>
	<entry>
		<id> https://www.researchprotocols.org/2026/1/e88268 </id>
		<title>An Evidence-Based Cognitive Stimulation and Physical Activity Intervention to Delay Aging-Related Decline: Protocol for a Randomized Controlled Trial</title>
		<updated>2026-07-08T06:30:02-04:00</updated>

					<author>
				<name>Yook Chin Chia</name>
			</author>
					<author>
				<name>Eden Ngah Den Low</name>
			</author>
					<author>
				<name>Michael Jenkins</name>
			</author>
					<author>
				<name>Yun Li Lee</name>
			</author>
					<author>
				<name>Tin Tin Su</name>
			</author>
					<author>
				<name>Rozainee Khairudin</name>
			</author>
					<author>
				<name>Khazriyati Salehuddin</name>
			</author>
					<author>
				<name>Santha Vaithilingam</name>
			</author>
					<author>
				<name>Jactty Chew</name>
			</author>
					<author>
				<name>Wei Ling Lim</name>
			</author>
					<author>
				<name>Min Hooi Yong</name>
			</author>
					<author>
				<name>Alexandre Schaefer</name>
			</author>
				<link rel="alternate" href="https://www.researchprotocols.org/2026/1/e88268" />
					<summary type="html" xml:base="https://www.researchprotocols.org/2026/1/e88268">&lt;strong&gt;Background:&lt;/strong&gt; The aging population presents both opportunities and challenges. Both global and Malaysian statistics have shown that an increase in longevity is also marked by an increase in the time spent in poor health. A key measure of healthy aging is the ability to lead an independent life. This has implications not only for the individual’s quality of life but also for society as a whole; loss of independence with age is associated with increased economic burden and reduced workforce productivity. Understanding and subsequently addressing these age-related declines (slowing or reversing them) is critical in improving the health and societal challenges faced by older adults. However, most studies are focused on Western populations. The scarcity of interventions tailored to multiethnic Asian populations is compounded by the fact that existing measurements rely heavily on Western-designed psychometric instruments, which frequently fail in capturing true cognitive health because of large cultural and educational gaps. &lt;strong&gt;Objective:&lt;/strong&gt; We aim to examine whether our long-term intervention packages can, over 4 years, significantly slow down the normal rate of aging-related decline in cognitive function and brain structure and function, as well as assess changes in aging-related salivary biomarkers. We will also measure the economic impact of such interventions in a cost-benefit analysis. &lt;strong&gt;Methods:&lt;/strong&gt; We propose 3 ecologically valid intervention packages (cognitive stimulation, physical activity, or both combined) and aim to assess them against a control group. We will target a sample of 400 participants as representative of the population of community-dwelling aging citizens in Malaysia (aged 60 years and older). The 5 projects of this study examined (1) psychology (social interaction and emotional well-being); (2) neuroscience, looking at neural markers of cognition (magnetic resonance imaging and electroencephalogram); (3) decision-making (risk and challenges in decision making); (4) economics (cost-benefits and effectiveness of the study interventions); and (5) biological markers of aging, using salivary samples. The Sunway University Institutional Review Board has reviewed and approved the study (SUREC2020/039). &lt;strong&gt;Results:&lt;/strong&gt; Briefly, primary outcomes will include changes in cognitive scores (Montreal Cognitive Assessment), changes in cognitive behavioral measurements, changes in electroencephalogram and structural magnetic resonance imaging, changes in everyday problem-solving and Iowa gambling task scores, changes in salivary biomarkers (lactoferrin, C-reactive protein, and telomere length), and cost-benefit analysis of the intervention. The study grant was awarded in August 2019, with recruitment starting in May 2022 and concluding in July 2023. In 2023, the intervention phase began and is currently ongoing, with the first publications of outcomes expected in 2026. &lt;strong&gt;Conclusions:&lt;/strong&gt; The effectiveness of these interventions will be examined from the perspective of multiple disciplines, including psychology, neuroscience, biology, and economics. We anticipate that the results of our study will be of interest to both the academic and general community and will hopefully influence policymaking. We hope that this study will provide robust and impactful, evidence-based insights on healthy aging and, thus, contribute to improving the overall quality of life associated with aging. &lt;strong&gt;Trial Registration:&lt;/strong&gt; ClinicalTrials.gov NCT06376656; https://clinicaltrials.gov/study/NCT06376656 </summary>
		
        
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		<published>2026-07-08T06:30:02-04:00</published>
	</entry>
	<entry>
		<id> https://www.researchprotocols.org/2026/1/e91051 </id>
		<title>Yiqi Fumai Lyophilized Injection for Improving Exercise Tolerance in Chronic Heart Failure: Protocol for a Prospective Cohort Study</title>
		<updated>2026-07-07T15:00:05-04:00</updated>

					<author>
				<name>Yiming Zuo</name>
			</author>
					<author>
				<name>Yunfeng Jia</name>
			</author>
					<author>
				<name>Lu Fan</name>
			</author>
					<author>
				<name>Yayi Liu</name>
			</author>
					<author>
				<name>Yuxiao Cao</name>
			</author>
					<author>
				<name>Miaomiao Wei</name>
			</author>
					<author>
				<name>Lei Wei</name>
			</author>
					<author>
				<name>Xiaoling Wang</name>
			</author>
					<author>
				<name>Xuezheng Liu</name>
			</author>
					<author>
				<name>Shichao Lv</name>
			</author>
				<link rel="alternate" href="https://www.researchprotocols.org/2026/1/e91051" />
					<summary type="html" xml:base="https://www.researchprotocols.org/2026/1/e91051">Background: High mortality and prevalence rates are hallmarks of chronic heart failure (CHF). Patients frequently have a much lower quality of life as a result of diminished exercise tolerance. Chinese guidelines have recommended Yiqi Fumai lyophilized injection (YQFM) for the treatment of heart failure, although there is currently inadequate evidence to support its effectiveness in increasing exercise tolerance in these patients. Objective: The purpose of this cohort study is to examine the relationship between the improvement of exercise tolerance in patients with CHF and the addition of YQFM to guideline-directed medical therapy. Methods: In total, 216 hospitalized patients with CHF with New York Heart Association (NYHA) functional classes II-IV were to be enrolled in the prospective, observational cohort trial design. The participants were divided into a YQFM group (exposed group: n=144) and a non-YQFM group (nonexposed group: n=72) at a 2:1 ratio based on real clinical medication and patient preference. Standard guideline-directed medical therapy was administered to both groups; however, the YQFM group also got a 10-day YQFM exposure. The change in metabolic equivalents measured by the Veterans Specific Activity Questionnaire was the main outcome. The 6-minute walk distance, Kansas City Cardiomyopathy Questionnaire score, NYHA functional class, N-terminal pro-B-type natriuretic peptide levels, and echocardiographic parameters were among the secondary objectives. Traditional Chinese medicine syndrome scores and the frequency of hard clinical occurrences were the exploratory objectives. A linear mixed-effects model was used to examine repeated measurement data, and propensity score weighting was used to account for baseline confounding variables. Results: The first patient was registered in June 2024, and all 216 patients had been recruited and followed up with by December 2025. Data cleaning and statistical analysis began in January 2026, with final results scheduled to be published in the autumn of 2026. Conclusions: This study, using a prospective cohort design, intends to offer high-quality, real-world evidence for the use of YQFM in cardiac rehabilitation for heart failure. This will aid in the optimization of preventative and treatment strategies for CHF that combine traditional Chinese and Western medicine, giving an objective basis for enhancing patients’ long-term quality of life. Trial Registration: International Traditional Medicine Clinical Trial Registry ITMCTR2024000541; https://itmctr.ccebtcm.org.cn/mgt/project/view/4887015277506364238 International Registered Report Identifier (IRRID): DERR1-10.2196/91051</summary>
		
        
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		<published>2026-07-07T15:00:05-04:00</published>
	</entry>
	<entry>
		<id> https://www.researchprotocols.org/2026/1/e67870 </id>
		<title>Characterizing the Epidemiology of Influenza A Viruses at the Swine-Human Interface: Study Protocol of the PigFluCam+ Project in Cambodia</title>
		<updated>2026-07-07T13:00:26-04:00</updated>

					<author>
				<name>Hannah Holt</name>
			</author>
					<author>
				<name>Arata Hidano</name>
			</author>
					<author>
				<name>William T M Leung</name>
			</author>
					<author>
				<name>Monivan Chhour</name>
			</author>
					<author>
				<name>Sokmony Yib</name>
			</author>
					<author>
				<name>Monidarin Chou</name>
			</author>
					<author>
				<name>Vonthanak Saphonn</name>
			</author>
					<author>
				<name>Chan Leakhena Phoeung</name>
			</author>
					<author>
				<name>Ty Chhay</name>
			</author>
					<author>
				<name>Sothyra Tum</name>
			</author>
					<author>
				<name>Sina Vor</name>
			</author>
					<author>
				<name>Sokchea Huy</name>
			</author>
					<author>
				<name>San Sorn</name>
			</author>
					<author>
				<name>Foong Ying Wong</name>
			</author>
					<author>
				<name>Michael Zeller</name>
			</author>
					<author>
				<name>Gavin J D Smith</name>
			</author>
					<author>
				<name>Yvonne C F Su</name>
			</author>
					<author>
				<name>James W Rudge</name>
			</author>
				<link rel="alternate" href="https://www.researchprotocols.org/2026/1/e67870" />
					<summary type="html" xml:base="https://www.researchprotocols.org/2026/1/e67870">Background: Influenza A viruses are a significant cause of global morbidity, mortality, and economic losses. Swine are considered an important host for pandemic emergence; however, knowledge on the ecology and evolution of swine influenza viruses in relation to pig production and exchange systems is limited. The PigFluCam+ project was first initiated in 2019 as a One Health–focused research collaboration between public and animal health stakeholders in Cambodia. Objective: The primary objectives of the project were to (1) describe the epidemiology and diversity of swine influenza A viruses (swIAVs) in the Cambodian pig sector, (2) assess the risk of zoonotic influenza transmission across different occupations, (3) characterize the pig trade network, (4) develop mathematical models of swIAV transmission to target control activities, and (5) promote in-country One Health research and surveillance. This paper presents the methods and approaches used by the project, serving as a resource for future research initiatives with similar aims. Methods: These approaches consist of systematic sample collections and survey studies. Influenza surveillance in pigs was conducted over 2 years through repeated (monthly) cross-sectional sampling at 18 slaughterhouses across 4 provinces. Phylogenetic analysis was used to describe the diversity of swIAVs detected and was used to develop antigens for Luminex xMAP assays for screening human and pig sera. Cross-sectional surveys among actors in the pig value chain characterized pig production practices and trading networks. In parallel, a cohort study was carried out involving households with and without occupational exposure to live pigs to compare the seroprevalence of influenza A viruses among different swine-associated occupational groups. Results: The surveys began in 2020 and despite disruptions caused by the COVID-19 pandemic and the introduction of African Swine Fever into the region, the project has generated a wealth of data. Over 4000 pigs were sampled at slaughterhouses, and network surveys collected pig production and trading data from 379 study participants. Higher influenza A seroprevalence (960/2399, 40%) and prevalence (37/2413, 1.5%) were found among pigs from commercial farms, compared to smallholder farms (seroprevalence 8.9%, 95/1066; prevalence 0.6%, 6/1071). Duration at slaughterhouse and seroprevalence correlated positively, suggesting potential transmission after leaving the farm. A total of 997 individuals were recruited into the cohort study, with 775 consenting to provide at least 1 serum sample. Funding for the project ended in September 2025; 3 results papers and 1 PhD thesis have been published, with analysis and publication expected to be completed by the end of 2026. Conclusions: This project has developed surveillance protocols and modern technologies for establishing active zoonotic disease surveillance. These efforts support the region’s capability to effectively identify zoonotic pathogens and enhance the prediction and response to zoonotic outbreaks and pandemic risk associated with pig production systems in the Lower Mekong region. International Registered Report Identifier (IRRID): DERR1-10.2196/67870</summary>
		
        
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		<published>2026-07-07T13:00:26-04:00</published>
	</entry>
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