Safety and Intranasal Retention of a Broad-Spectrum Anti-SARS-CoV-2 Monoclonal Antibody SA55 Nasal Spray in Healthy Volunteers: A Phase I Clinical Trial by Chaoying Hu, Yibo Zhou, Xing Meng, Jianhua Li, Jinxia Chen, Zhifang Ying, Xiaoliang Sunney Xie, Yaling Hu, Yunlong Cao, Ronghua Jin

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Effects of exercise and exercise timing on energy intake and appetite control in Danish individuals with overweight or obesity with and without type 2 diabetes: a protocol for a randomised controlled cross-over trial by Louise Groth Grunnet, Martin Bæk Blond, Jonas Salling Quist, Kristine Beaulieu, Graham Finlayson, Kristine Færch, Lea Jalking, Natja Poder Launbo, Marie Møller Jensen, Hanne Enghoff Pedersen, Marina Kjærgaard Gerstenberg

“…All results will be published in national and international peer-reviewed journals and will be disseminated at national and international conferences.Trial registration number NCT05768958.…”
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Effectiveness of Cognitive Behavioral Therapy Provided Through a Web Application for Subthreshold Depression, Subthreshold Insomnia, and Subthreshold Panic: Open-Labeled 6-Arm Randomized Clinical Trial Pilot Study by Kayoko Taguchi, Mirai Miyoshi, Yoichi Seki, Shiori Baba, Eiji Shimizu

“…In particular, it is difficult to define SP, and further research that considers the specific factors of each subthreshold symptom is necessary to accumulate evidence. Trial RegistrationUniversity Hospital Medical Information Network (UMIN) UMIN000051280; https://tinyurl.com/2wyahhe3…”
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Effects of apple cider vinegar on glycemic control and insulin sensitivity in patients with type 2 diabetes: A GRADE-assessed systematic review and dose–response meta-analysis of controlled clinical trials by Donya Arjmandfard, Mehrdad Behzadi, Zahra Sohrabi, Mohsen Mohammadi Sartang

“…This study aimed to evaluate the effects of ACV on glycemic profile in type 2 diabetes patients (T2DM) in controlled trials (CTs) by systematically reviewing and dose–response meta-analysis.MethodsThe Scopus, PubMed, and Web of Science databases were searched until November 2024 according to a systematic approach. …”
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The Effects of MyChoices and LYNX Mobile Apps on HIV Testing and Pre-Exposure Prophylaxis Use by Young US Sexual Minority Men: Results From a National Randomized Controlled Trial by Katie B Biello, Kenneth H Mayer, Hyman Scott, Pablo K Valente, Jonathan Hill-Rorie, Susan Buchbinder, Lucinda Ackah-Toffey, Patrick S Sullivan, Lisa Hightow-Weidman, Albert Y Liu

“…ConclusionsIn addition to facilitating earlier treatment among those who become aware of their HIV status, given the ubiquity of mobile apps and modest resources required to scale this intervention, a 25% relative increase in HIV testing among young sexual minority men, as seen in this study, could meaningfully reduce HIV incidence in the United States. Trial RegistrationClinicalTrials.gov NCT03965221; https://clinicaltrials.gov/study/NCT03965221…”
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Radiotherapy(R) Integration(I) Strategy for Small(S)-Cell Lung Cancer in Extensive(E) Stage (RISE) with up to 10 metastases- a study protocol of a randomized phase II trial by Łukasz Kuncman, Jacek Fijuth, Damian Tworek, Ewa Sierko, Paweł Cisek, Michał Masłowski, Maja Lisik-Habib, Magdalena Orzechowska, Katarzyna Galwas-Kliber, Adam Antczak, Izabela Chmielewska, Barbara Ziółkowska, Marta Kurczewska-Michalak, Wojciech Kuźnicki, Nina Jędrzejczak, Kinga Ranoszek, Mateusz Bilski

“…Dose-escalated chest RT and SBRT (for up to 10 metastases) administered with modern techniques offer the possibility to improve OS and PFS. Trial registration Clinicaltrials.gov NCT06529081 (Registered 26th Jul 2024).…”
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Efficacy of Patellar Taping and Electromyographic Biofeedback Training at Various Knee Angles on Quadriceps Strength and Functional Performance in Young Adult Male Athletes with Patellofemoral Pain Syndrome: A Randomized Controlled Trial by Shahnaz Hasan, Asma Alonazi, Shahnawaz Anwer, Azfar Jamal, Suhel Parvez, Faiz Abdulaziz Saleh Alfaiz, Heng Li

“…The findings indicated that individuals who trained their quadriceps at a 60° knee angle had significantly stronger quadriceps muscles than individuals who trained at 30° or 90° of knee flexion. Trial Registration. This trial is registered at Clinical Trials.gov under the identifier NCT05055284.…”
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A pilot mixed methods randomized control trial investigating the feasibility and acceptability of a culturally tailored intervention focused on beliefs, mistrust and race-congruent peer support for Black adults with diabetes by Meng-Jung Wen, Martha Maurer, Annika L. Pickard, Makenzie Hansen, Olayinka O. Shiyanbola

“…This 6-month pilot randomized feasibility trial compared a culturally tailored diabetes self-management program, incorporating beliefs about diabetes, mistrust, and race-congruent peer support to a standard diabetes program.MethodsAn embedded mixed methods design examined the feasibility of the pilot trial, including recruitment, retention, intervention adherence and participant acceptability. …”
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Improving Health Outcomes in Coronary Artery Disease Patients with Short-Term Protocols of High-Intensity Interval Training and Moderate-Intensity Continuous Training: A Community-Based Randomized Controlled Trial by Catarina Gonçalves, Jorge Bravo, João Pais, Ana Abreu, Armando Raimundo

“…In this randomized controlled trial, body composition, aerobic capacity, muscle strength, and daily PA levels were assessed before and after 6 weeks of intervention in 69 patients diagnosed with CAD. …”
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Impact of a phone call with a medical student/general practitioner team on morbidity of chronic patients during the first French COVID-19 lockdown (COVIQuest): a cluster randomised trial by Bruno Giraudeau, Estelle Boivin, Vincent Camus, Agnes Caille, Olivier Saint-Lary, Jean-Pierre Lebeau, Stéphanie Sidorkiewicz, Denis Pouchain, Maeva Jego, Sophie Sun, Denis Angoulvant, Wissam El-Hage, Sébastien Bruel, Clarisse Dibao-Dina, Julie Léger, Isabelle Ettori-Ajasse, Juliette Chambe, Karim Abou-Mrad-Fricquegnon, Baptiste Motte, Benoit Chiron, Cam-Anh Khau, Tiphanie Bouchez, Maria Ghali, Leslie Guillon-Grammatico, Emeline Laurent, Rémy Boussageon

“…Overall, 27 (3.25%) patients were hospitalised in the intervention group vs 12 (2.19%) in the control group (OR 1.52, 95% CI 0.82 to 2.81; risk difference 1.38, 95% CI 0.06 to 2.70).Conclusion A GP-initiated phone call may have been associated with more hospitalisations within 1 month for patients with MHD, but results lack robustness and significance depending on the statistical approach used.Trial registration number NCT04359875.…”
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Efficacy of the Foodbot Factory digital curriculum-based nutrition education intervention in improving children’s nutrition knowledge, attitudes and behaviours in elementary school classrooms: protocol for a cluster randomised controlled trial by Wendy Lou, Michael Farkouh, JoAnne Arcand, Jacqueline Marie Brown, Saman Tahir, Beatriz Franco-Arellano, Ann LeSage, Janette Hughes, Bill Kapralos, Ellen Vogel, Claire Tugault-Lafleur

“…Generalised linear mixed models will assess changes in outcomes between groups.Ethics and dissemination The study protocol is approved by research ethics boards at Ontario Tech University and participating school boards. Results of the trial will be published in peer-reviewed journals and lay summaries will be available to stakeholders.Trial registration number NCT05979259.…”
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Increased Macular Pigment Optical Density and Visual Acuity following Consumption of a Buttermilk Drink Containing Lutein-Enriched Egg Yolks: A Randomized, Double-Blind, Placebo-Controlled Trial by Sanne M. van der Made, Elton R. Kelly, Aize Kijlstra, Jogchum Plat, Tos T. J. M. Berendschot

“…One hundred and one subjects were recruited to participate in this randomized, double-blind, placebo-controlled parallel intervention trial. Statistical analyses were performed with 46 subjects in the lutein group and 43 in the control group. …”
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Multicentre, 26-week, open-label phase 2 trial of the JAK inhibitor filgotinib in Behçet’s disease, idiopathic inflammatory myopathies and IgG4-related disease: DRIMID study protocol by Sander W Tas, Joost Raaphorst, Paco M J Welsing, Jacob M van Laar, Rogier M Thurlings, Robbert J Goekoop, César Magro Checa, Jan A M van Laar, Bettina C Geertsema-Hoeve, Nicolle H Rekers, Erik Present

“…A Data Safety Monitoring Board has been established to monitor the trial’s safety and progress.Trial registration number NCT06285539.…”
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Active versus sham transcranial direct current stimulation (tDCS) as an adjunct to varenicline treatment for smoking cessation: Study protocol for a double-blind single dummy randomized controlled trial. by Laurie Zawertailo, Helena Zhang, Noreen Rahmani, Tarek K Rajji, Peter Selby

“…<h4>Methods</h4>This is a double-blind, sham-controlled randomized clinical trial where fifty healthy smokers will be recruited in Toronto, Canada. …”
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Deep neuromuscular blockade during radiofrequency catheter ablation under general anesthesia reduces the prevalence of atrial fibrillation recurrence when compared to moderate neuromuscular blockade: A randomized controlled trial by Eun Jung Oh, Jae-Geum Shim, Suyong Jeon, Eun Ah Cho, Sung Hyun Lee, Taeho Jeong, Jin Hee Ahn

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Combination Treatments of Plasma Exchange and Umbilical Cord-Derived Mesenchymal Stem Cell Transplantation for Patients with Hepatitis B Virus-Related Acute-on-Chronic Liver Failure: A Clinical Trial in China by Wen-xiong Xu, Hong-liang He, Shun-wen Pan, Yuan-li Chen, Mei-ling Zhang, Shu Zhu, Zhi-liang Gao, Liang Peng, Jian-guo Li

“…The long-term efficacy should be further evaluated. This trial is registered with registration no. NCT01724398.…”
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Olutasidenib in combination with azacitidine induces durable complete remissions in patients with relapsed or refractory mIDH1 acute myeloid leukemia: a multicohort open-label phase 1/2 trial by Jorge E. Cortes, Gail J. Roboz, Maria R. Baer, Brian A. Jonas, Gary J. Schiller, Karen Yee, P. Brent Ferrell, Jay Yang, Eunice S. Wang, William G. Blum, Alice Mims, Hua Tian, Aaron Sheppard, Stéphane de Botton, Pau Montesinos, Antonio Curti, Justin M. Watts, the Olutasidenib Combination Therapy Study Group

“…Abstract Background Olutasidenib is a potent, selective, oral, small molecule inhibitor of mutant IDH1 (mIDH1) which induced durable remissions in high-risk, relapsed/refractory (R/R) mIDH1 AML patients in a phase 1/2 trial. We present a pooled analysis from multiple cohorts of the phase 1/2 trial of patients with R/R AML who received combination olutasidenib and azacitidine therapy. …”
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Multimodal smoking cessation treatment combining repetitive transcranial magnetic stimulation, cognitive behavioral therapy, and nicotine replacement in veterans with posttraumatic stress disorder: A feasibility randomized controlled trial protocol. by Jonathan R Young, Carri S Polick, Andrew M Michael, Moritz Dannhauer, Jeffrey T Galla, Mariah K Evans, Addison Troutman, Angela C Kirby, Michelle F Dennis, Claire W Papanikolas, Zhi-De Deng, Scott D Moore, Eric A Dedert, Merideth A Addicott, Lawrence G Appelbaum, Jean C Beckham

“…Thus, we propose a feasibility phase II randomized controlled trial (RCT) to study a form of repetitive transcranial magnetic stimulation (rTMS) called intermittent theta burst stimulation (iTBS). iTBS has the advantage of allowing for a patterned form of stimulation delivery that we will administer at 90% of the subject's resting motor threshold (rMT) applied over a region in the right post-central gyrus most functionally connected to the right posterior insula. …”
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Rectal versus vaginal progesterone administration for luteal phase support in the hormone replacement therapy frozen embryo transfer (HRT-FET) cycle: protocol for a non-inferiority randomised controlled trial by Peter Humaidan, Birgit Alsbjerg

“…The results will be published in an international journal.Trial registration number EUCT number: 2023-504616-15-02.…”
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Effect of Early-Intervention Acupuncture on Pain Relief Among Emergency Department Patients with Suspected Acute Renal Colic Due to Urinary Calculi: Study Protocol for a Randomized Clinical Trial [Letter] by Yang S, Yang W, Gao H

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