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Journal articles on the topic 'Multicenter trial effectiveness'

Author: Grafiati

Published: 2 June 2025

Last updated: 31 July 2025

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1

Holbrook, Janet T., John H. Kempen, Nancy A. Prusakowski, Michael M. Altaweel, and Douglas A. Jabs. "Challenges in the design and implementation of the Multicenter Uveitis Steroid Treatment (MUST) Trial – lessons for comparative effectiveness trials." Clinical Trials 8, no. 6 (2011): 736–43. http://dx.doi.org/10.1177/1740774511423682.

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Background Randomized clinical trials (RCTs) are an important component of comparative effectiveness (CE) research because they are the optimal design for head-to-head comparisons of different treatment options. Purpose To describe decisions made in the design of the Multicenter Uveitis Steroid Treatment (MUST) Trial to ensure that the results would be widely generalizable. Methods Review of design and implementation decisions and their rationale for the trial. Results The MUST Trial is a multicenter randomized controlled CE trial evaluating a novel local therapy (intraocular fluocinolone acet

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Hughes, Susan L. "Effectiveness of Team-Managed Home-Based Primary CareA Randomized Multicenter Trial." JAMA 284, no. 22 (2000): 2877. http://dx.doi.org/10.1001/jama.284.22.2877.

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Warden, Diane, A. John Rush, Madhukar Trivedi, Louise Ritz, Diane Stegman, and Stephen R. Wisniewski. "Quality improvement methods as applied to a multicenter effectiveness trial—STAR*D." Contemporary Clinical Trials 26, no. 1 (2005): 95–112. http://dx.doi.org/10.1016/j.cct.2004.11.011.

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Wilson, M. Edward, and Rupal H. Trivedi. "Multicenter Randomized Controlled Clinical Trial in Pediatric Cataract Surgery: Efficacy and Effectiveness." American Journal of Ophthalmology 144, no. 4 (2007): 616–17. http://dx.doi.org/10.1016/j.ajo.2007.06.033.

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Luerti, Massimo, Amerigo Vitagliano, Attilio Di Spiezio Sardo, et al. "Effectiveness of Hysteroscopic Techniques for Endometrial Polyp Removal: The Italian Multicenter Trial." Journal of Minimally Invasive Gynecology 26, no. 6 (2019): 1169–76. http://dx.doi.org/10.1016/j.jmig.2018.12.002.

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Arntz, A. "Schema-focused therapy for borderline personality disorder: Effectiveness and cost-effectiveness, evidence from a multicenter trial." European Psychiatry 23 (April 2008): S65—S66. http://dx.doi.org/10.1016/j.eurpsy.2008.01.238.

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Lund, Jennifer Leigh, Michael Webster-Clark, Alexander P. Keil, Daniel Westreich, Til Sturmer, and Hanna Kelly Sanoff. "Effectiveness of adjuvant FOLFOX versus 5FU for colon cancer treatment in community oncology practice using a hybrid study approach." Journal of Clinical Oncology 38, no. 15_suppl (2020): 7067. http://dx.doi.org/10.1200/jco.2020.38.15_suppl.7067.

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7067 Background: Treatment effects may differ between trials and community settings, in part due to underrepresentation of certain patient subgroups in trials. We used a hybrid approach combining clinical trial and real-world data to compare the effectiveness of adjuvant FOLFOX vs 5FU for stage II-III colon cancer in community oncology practice. Methods: We used Multicenter International Study of Oxaliplatin/5FU-LV in the Adjuvant Treatment of Colon Cancer (MOSAIC) combined with patients who met trial eligibility criteria within US Oncology from 1/1/2008-5/31/2019. In the combined data, we use

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Hidler, Joseph, Diane Nichols, Marlena Pelliccio, et al. "Multicenter Randomized Clinical Trial Evaluating the Effectiveness of the Lokomat in Subacute Stroke." Neurorehabilitation and Neural Repair 23, no. 1 (2008): 5–13. http://dx.doi.org/10.1177/1545968308326632.

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Objective. To compare the efficacy of robotic-assisted gait training with the Lokomat to conventional gait training in individuals with subacute stroke. Methods. A total of 63 participants <6 months poststroke with an initial walking speed between 0.1 to 0.6 m/s completed the multicenter, randomized clinical trial. All participants received twenty-four 1-hour sessions of either Lokomat or conventional gait training. Outcome measures were evaluated prior to training, after 12 and 24 sessions, and at a 3-month follow-up exam. Self-selected overground walking speed and distance walked in 6 min

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Rodrigues, Ana Luiza Soares, Beatriz Guitton Renaud Baptista de Oliveira, Débora Omena Futuro, and Silvia Regina Secoli. "Effectiveness of papain gel in venous ulcer treatment: randomized clinical trial." Revista Latino-Americana de Enfermagem 23, no. 3 (2015): 458–65. http://dx.doi.org/10.1590/0104-1169.0381.2576.

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OBJECTIVE: to assess the effectiveness of 2% papain gel compared to 2% carboxymethyl cellulose in the treatment of chronic venous ulcer patients.METHOD: randomized controlled clinical trial with 12-week follow-up. The sample consisted of 18 volunteers and 28 venous ulcers. In the trial group, 2% papain gel was used and, in the control group, 2% carboxymethyl cellulose gel.RESULTS: the trial group showed a significant reduction in the lesion area, especially between the fifth and twelfth week of treatment, with two healed ulcers and a considerable increase in the amount of epithelial tissue in

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Busso, Mariano, Marion Moers-Carpi, Ragnar Storck, Patricia Ogilvie, and Alexandra Ogilvie. "Multicenter, Randomized Trial Assessing the Effectiveness and Safety of Calcium Hydroxylapatite for Hand Rejuvenation." Dermatologic Surgery 36, Sup 1 (2010): 790–97. http://dx.doi.org/10.1111/j.1524-4725.2010.01568.x.

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Krepel, Noralie, Tommy Egtberts, Alexander T. Sack, Hartmut Heinrich, Mark Ryan, and Martijn Arns. "A multicenter effectiveness trial of QEEG-informed neurofeedback in ADHD: Replication and treatment prediction." NeuroImage: Clinical 28 (2020): 102399. http://dx.doi.org/10.1016/j.nicl.2020.102399.

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Shevchuk, I. M., and A. S. Kalpinskiy. "Biosimilars in the practice of modern oncologist." Cancer Urology 19, no. 4 (2024): 176–88. http://dx.doi.org/10.17650/1726-9776-2023-19-4-176-188.

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Currently, genetically engineered drugs are widely used in oncological clinical practice which has significantly increased treatment cost. One of the most effective ways to decrease cost is substitution of an innovative drug after patent expiration with a reproduced compound – biosimilar.In this article, a problem of biosimilars is actualized both worldwide and in Russia, characteristics of these products are described, and the path of the agents from the moment of reproduction through preclinical and clinical trials to introduction into real clinical practice is traced, examples of such trial

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Costa, Suzete, José Luís Biscaia, Maria Rute Horta, et al. "Real-World Effectiveness in Hypertension and Hyperlipidemia Collaborative Management between Pharmacies and Primary Care in Portugal: A Multicenter Pragmatic Controlled Trial (USFarmácia®)." International Journal of Environmental Research and Public Health 20, no. 15 (2023): 6496. http://dx.doi.org/10.3390/ijerph20156496.

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There is evidence of the efficacy of collaborative health interventions with pharmacies and primary care providers but little of its real-world effectiveness. We aimed to assess the effectiveness and discuss the design and challenges of hypertension and hyperlipidemia management between pharmacies and primary care providers using real-world data exchange between providers and experimental bundled payment. This was a pragmatic, quasi-experimental controlled trial. We collected patient-level data from primary care prescription claims and Electronic Medical Record databases, a pharmacy claims dat

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Gajdos, Vincent, Sandrine Katsahian, Nicole Beydon, et al. "Effectiveness of Chest Physiotherapy in Infants Hospitalized with Acute Bronchiolitis: A Multicenter, Randomized, Controlled Trial." PLoS Medicine 7, no. 9 (2010): e1000345. http://dx.doi.org/10.1371/journal.pmed.1000345.

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Trentini, M., S. Semeraro, and M. Motta. "Effectiveness of geriatric evaluation and care. One-year results of a multicenter randomized clinical trial." Aging Clinical and Experimental Research 13, no. 5 (2001): 395–405. http://dx.doi.org/10.1007/bf03351509.

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Lee, Boram, Na-Yeon Ha, Hyo-Ju Park, et al. "Herbal Medicine Yukgunja-Tang for Functional Dyspepsia: A Protocol for a Randomized, Controlled, Multicenter Clinical Trial." Healthcare 11, no. 10 (2023): 1456. http://dx.doi.org/10.3390/healthcare11101456.

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The herbal medicine Yukgunja-tang has been widely used for the treatment of functional dyspepsia (FD) in the clinical setting of East Asian traditional medicine. This paper presents a protocol for a randomized, assessor-blind, controlled, multicenter, three-arm parallel clinical trial comparing the effectiveness, safety, and cost-effectiveness of Yukgunja-tang with Pyeongwi-san and usual care. A total of 140 participants with Rome IV-diagnosed FD will be randomly assigned to either the Yukgunja-tang (n = 56), Pyeongwi-san (n = 56), or usual care (n = 28) groups. All participants will be educat

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Nigah, Zahra, Nasim Chaudhry, Nusrat Husain, Imran Chaudhry, and Ishrat Husain. "A Multicenter Randomized Controlled Trial of Measurement-Based Care for Major Depressive Disorder in Pakistan." BJPsych Open 10, S1 (2024): S25. http://dx.doi.org/10.1192/bjo.2024.123.

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AimsA worldwide public health concern is major depressive disorder (MDD) with limited availability and access to evidence-based treatment in low- and middle-income countries (LMICs) such as Pakistan. Measurement-based care (MBC) is a low-cost strategy to improve clinical outcomes for people with MDD that involves the systematic administration of validated outcome measures to inform treatment decisions. However, research on MBC's effectiveness in LMICs is scarce. This paper aims to evaluate the feasibility and clinical effectiveness of MBC against standard care for patients with moderate to sev

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Livingston, M. H., T. Elliott, C. Williams, S. A. Jones, P. L. Rosenbaum, and J. M. Walton. "Glycerin suppositories used prophylactically in premature infants (supp): A pilot randomized controlled trial." Journal of Neonatal-Perinatal Medicine 13, no. 4 (2020): 495–505. http://dx.doi.org/10.3233/npm-190310.

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BACKGROUND: Glycerin suppositories are often used to facilitate meconium evacuation in premature infants. The evidence for this practice is inconclusive. The purpose of this study was to assess the feasibility of a multicenter randomized controlled trial on the effectiveness of this treatment strategy. STUDY DESIGN: We conducted an external pilot study for a multicenter randomized controlled trial of premature infants randomized to glycerin suppositories or placebo procedure. Participants were included if they were gestational age of 24 weeks 0 days to 31 weeks 6 days and/or birthweight of 500

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Kawashita, Yumiko, Masahiro Umeda, Maho Murata, et al. "Effectiveness of Hangeshashinto in delaying grade 2 radiotherapy-induced mucositis development in patients with hypopharyngeal or laryngeal cancer: Preliminary finding of a randomized clinical trial." Medicine 104, no. 24 (2025): e42870. https://doi.org/10.1097/md.0000000000042870.

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Background: The efficacy of Hangeshashinto (TJ-14) during radiotherapy administration in patients with head and neck cancer remains unknown. We investigated the effectiveness of TJ-14 in delaying grade 2 radiotherapy-induced mucositis development in patients with hypopharyngeal or laryngeal cancer. Methods: The trial involved 28 participants, allocated in a 1:1 ratio, to either the control or intervention group using a stratified randomization method adjusted for primary cancer location and treatment type. Results: Kaplan–Meier curves showed that the 50% incidence rate of grade 2 pharyngeal mu

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Lehmann, Birthe Andrea, Lara Lindert, Silke Ohlmeier, Lara Schlomann, Holger Pfaff, and Kyung-Eun Choi. "“And Then He Got into the Wrong Group”: A Qualitative Study Exploring the Effects of Randomization in Recruitment to a Randomized Controlled Trial." International Journal of Environmental Research and Public Health 17, no. 6 (2020): 1886. http://dx.doi.org/10.3390/ijerph17061886.

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Background: Randomized controlled trials (RCTs) are regarded as the most internally valid means of estimating the effectiveness of complex public health interventions, but the recruitment of participants can be difficult. The aim of this study was to explore factors that may have affected the recruitment of employees with musculoskeletal disorders (MSDs) to a multicenter worksite health promotion program from the perspective of recruiting case managers. Methods: Factors in recruitment to the RCT were explored using three focus group discussions with case managers. Data were processed using MAX

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Chan, Yu Tat, Hong Wei Zhang, Yuan Qi Guo, and Zhi-Xiu Lin. "Effectiveness and Safety of Acupuncture for Poststroke Dysphagia: Study Protocol for a Pragmatic Multicenter Nonrandomized Controlled Trial." Evidence-Based Complementary and Alternative Medicine 2017 (2017): 1–8. http://dx.doi.org/10.1155/2017/2349794.

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Background. Dysphagia is one of the most common complications of stroke. Acupuncture is widely employed to treat poststroke dysphagia in East Asia. No evidence is established to support such treatment approach. This proposed study aims to evaluate the effectiveness and safety of acupuncture for the treatment of poststroke dysphagia. Methods and Design. This is a multicenter, pragmatic, single-blinded, nonrandomized controlled clinical trial. A total of 140 eligible patients will be enrolled in the study. Subjects who are eligible in study but refuse to have acupuncture treatment will be put on

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Broekhuizen, Karen, David Simmons, Roland Devlieger, et al. "Cost-effectiveness of healthy eating and/or physical activity promotion in pregnant women at increased risk of gestational diabetes mellitus: economic evaluation alongside the DALI study, a European multicenter randomized controlled trial." International Journal of Behavioral Nutrition and Physical Activity 15, no. 1 (2018): 23. https://doi.org/10.1186/s12966-018-0643-y.

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<strong>Background: </strong>Gestational diabetes mellitus (GDM) is associated with perinatal health risks to both mother and offspring, and represents a large economic burden. The DALI study is a multicenter randomized controlled trial, undertaken to add to the knowledge base on the effectiveness of interventions for pregnant women at increased risk for GDM. The purpose of this study was to evaluate the cost-effectiveness of the healthy eating and/or physical activity promotion intervention compared to usual care among pregnant women at increased risk of GDM from a societal perspective.<stron

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Zhang, Shenghong, Danping Zheng, Jinping Wang, et al. "Simethicone improves bowel cleansing with low-volume polyethylene glycol: a multicenter randomized trial." Endoscopy 50, no. 04 (2017): 412–22. http://dx.doi.org/10.1055/s-0043-121337.

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Abstract Background and study aims For bowel preparation, using a reduced volume of polyethylene glycol (PEG) solution without influencing its effectiveness would be preferable. While simethicone shows great potential as an adjunctive agent, data on its use are limited. We aimed to clarify whether simethicone added to low-volume PEG solution improved bowel cleansing. Patients and methods Consecutive adult patients registered for colonoscopy were recruited from seven medical centers in South China between 15 April and 15 July 2015 and prospectively randomized into two groups: 2 L PEG (conventio

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Schenk, Worthington G., William D. Spotnitz, Sandra G. Burks, Peter H. Lin, Ruth L. Bush, and Alan B. Lumsden. "Absorbable Cyanoacrylate as a Vascular Hemostatic Sealant: A Preliminary Trial." American Surgeon 71, no. 8 (2005): 658–61. http://dx.doi.org/10.1177/000313480507100808.

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No absorbable cyanoacrylate tissue adhesive for safe internal surgical use is available. This prospective multicenter preliminary study was designed to evaluate the safety and effectiveness of an investigational absorbable cyanoacrylate (IAC) as an adjunct to hemostasis in arteriovenous shunt (AVS) procedures for dialysis access. Consenting adults (10) underwent placement of expanded polytetrafluoroethylene (ePTFE) upper extremity vascular grafts for AVS access using continuous 5-0 or 6-0 polypropylene after heparinization (≥3,000 units IV). Arterial anastomoses were evaluated after sealing wi

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Sonesson, M., S. Twetman, and L. Bondemark. "Effectiveness of high-fluoride toothpaste on enamel demineralization during orthodontic treatment--a multicenter randomized controlled trial." European Journal of Orthodontics 36, no. 6 (2013): 678–82. http://dx.doi.org/10.1093/ejo/cjt096.

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Bloemen, Monica C. T., Martijn B. A. van der Wal, Pauline D. H. M. Verhaegen, et al. "Clinical effectiveness of dermal substitution in burns by topical negative pressure: A multicenter randomized controlled trial." Wound Repair and Regeneration 20, no. 6 (2012): 797–805. http://dx.doi.org/10.1111/j.1524-475x.2012.00845.x.

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Panella, M., S. Marchisio, A. Barbieri, and ML Demarchi. "PCV21 EFFECTIVENESS OF CLINICAL PATHWAYS FOR INPATIENT HEARTH FAILURE TREATMENT: RESULTS OF A MULTICENTER CONTROLLED TRIAL." Value in Health 8, no. 3 (2005): 267. http://dx.doi.org/10.1016/s1098-3015(10)62662-9.

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Lane, S. S., B. D. Kuppermann, I. H. Fine, et al. "A prospective multicenter clinical trial to evaluate the safety and effectiveness of the implantable miniature telescope." American Journal of Ophthalmology 137, no. 6 (2004): 993–1001. http://dx.doi.org/10.1016/j.ajo.2004.01.030.

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Madhusudhana, K. C. "A prospective multicenter clinical trial to evaluate the safety and effectiveness of the implantable miniature telescope." American Journal of Ophthalmology 139, no. 2 (2005): 395. http://dx.doi.org/10.1016/j.ajo.2004.09.013.

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Wirz, Markus, David H. Zemon, Ruediger Rupp, et al. "Effectiveness of automated locomotor training in patients with chronic incomplete spinal cord injury: A multicenter trial." Archives of Physical Medicine and Rehabilitation 86, no. 4 (2005): 672–80. http://dx.doi.org/10.1016/j.apmr.2004.08.004.

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Mozingo, D. W. "Clinical effectiveness of dermal substitution in burns by topical negative pressure: A multicenter randomized controlled trial." Yearbook of Surgery 2013 (2013): 58–59. https://doi.org/10.1016/j.ysur.2013.04.001.

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John, Denny, Pooja Reddy, Anuja Jha, et al. "Protocol for the economic evaluation alongside the PARTICIPATE (PArticipatory Research model for medicaTIon adherenCe In People with diAbetes and hyperTEnsion) multicenter cluster randomized trial." BMJ Open 15, no. 7 (2025): e094185. https://doi.org/10.1136/bmjopen-2024-094185.

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Introduction Using the community-based participatory research (CBPR) methodology, sustained peer group treatment has effectively improved medication adherence. Although many studies investigate the effectiveness of peer group therapy, there is a lack of evidence addressing the cost-effectiveness of CBPR models in low- and middle-income countries. This protocol outlines the methods for the economic evaluation of the PArticipatory Research model for medicaTIon adherenCe In People with diAbetes and hyperTEnsion (PARTICIPATE) trial to determine whether the CBPR approach to enhance medication adher

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Fan, Frankie, Moiz Shakeel, Nafisa Boota, Hilary Adamson, Ajay Verma, and Karen Brown. "Abstract LB148: Perspectives of clinical trial staff on recruitment barriers to a multicenter randomized controlled colorectal polyp prevention trial." Cancer Research 85, no. 8_Supplement_2 (2025): LB148. https://doi.org/10.1158/1538-7445.am2025-lb148.

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Abstract Background: Participant recruitment remains a pervasive issue in clinical trial management. Colorectal cancer (CRC) is a growing cause of cancer-related morbidity and mortality globally, making CRC prevention crucial. COLO-PREVENT is a 10-year multicenter randomized controlled trial platform assessing the efficacy of aspirin versus aspirin plus metformin in a phase 3 study, alongside a phase 2 study of resveratrol compared to placebo for the prevention of colorectal polyps in high-risk individuals identified via the Bowel Cancer Screening Program (BCSP) in the United Kingdom. It aims

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Bove, Allyn M., Kenneth J. Smith, Christopher G. Bise, et al. "Exercise, Manual Therapy, and Booster Sessions in Knee Osteoarthritis: Cost-Effectiveness Analysis From a Multicenter Randomized Controlled Trial." Physical Therapy 98, no. 1 (2017): 16–27. http://dx.doi.org/10.1093/ptj/pzx104.

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Abstract Background Limited information exists regarding the cost-effectiveness of rehabilitation strategies for individuals with knee osteoarthritis (OA). Objective The study objective was to compare the cost-effectiveness of 4 different combinations of exercise, manual therapy, and booster sessions for individuals with knee OA. Design This economic evaluation involved a cost-effectiveness analysis performed alongside a multicenter randomized controlled trial. Setting The study took place in Pittsburgh, Pennsylvania; Salt Lake City, Utah; and San Antonio, Texas. Participants The study partici

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Hasegawa, Kiyoshi, Norihiro Kokudo, and Yutaka Matsuyama. "A randomized controlled trial to compare the effectiveness between surgery and radiofrequency ablation for hepatocellular carcinoma: SURF trial." Journal of Clinical Oncology 35, no. 4_suppl (2017): TPS506. http://dx.doi.org/10.1200/jco.2017.35.4_suppl.tps506.

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TPS506 Background: Which is superior to treat hepatocellular carcinoma (HCC), surgery or percutaneous ablation? This has been one of the most important questions in clinical research of hepatology. However, it has long remained unanswered because it is difficult to approach, as we mentioned previously (Ann Surg 2008;247:557-8). Thus, in 2009, we started this multicenter study in Japan to reach a strong conclusion to the above question (UMIN:000001795). Methods: The major inclusion criteria are: tumor foci numbering three or fewer, and each measuring 3 cm or less); Child–Pugh score of 7 or less

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Fang, Jennifer L., Rachel A. Umoren, Hilary Whyte, et al. "Evaluating the feasibility of a multicenter teleneonatology clinical effectiveness trial." Pediatric Research, May 19, 2023. http://dx.doi.org/10.1038/s41390-023-02659-2.

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Gedin, Filip, Martin Skeppholm, Vibeke Sparring, and Niklas Zethraeus. "Effectiveness and cost-effectiveness of chiropractic and physiotherapy for chronic low back pain: a multicenter RCT in Sweden." BMC Musculoskeletal Disorders 26, no. 1 (2025). https://doi.org/10.1186/s12891-025-08392-7.

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Abstract Objective To evaluate the effectiveness and cost-effectiveness of physiotherapy, chiropractic care, and the combination of physiotherapy and chiropractic care compared with information and advice for the treatment of patients with nonspecific chronic low-back pain (CLBP) in Sweden. Design A multicentre pragmatic randomized controlled trial. Setting Ten primary care rehabilitation units in Sweden. Participants Eighty-eight participants with nonspecific CLBP. Interventions The participants were randomly assigned to receive physiotherapy, chiropractic care, combination treatment, or info

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WARDEN, D., A. RUSH, M. TRIVEDI, L. RITZ, D. STEGMAN, and S. WISNIEWSKI. "Quality improvement methods as applied to a multicenter effectiveness trial?STAR*D." Controlled Clinical Trials, December 31, 2004. http://dx.doi.org/10.1016/j.cct.2004.11.010.

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Tian, Heshen, Yumin Zhou, Longhui Tang, et al. "High-dose N-acetylcysteine for long-term, regular treatment of early-stage chronic obstructive pulmonary disease (GOLD I–II): study protocol for a multicenter, double-blinded, parallel-group, randomized controlled trial in China." Trials 21, no. 1 (2020). http://dx.doi.org/10.1186/s13063-020-04701-8.

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Abstract Introduction The presence of increased oxidative stress and airway inflammation has been proven in subjects with chronic obstructive pulmonary disease (COPD). Several studies have demonstrated that drugs with antioxidant and anti-inflammatory properties such as N-acetylcysteine (NAC) can reduce the rate of exacerbations in patients with COPD. However, the beneficial effects of NAC in early-stage COPD are minimally discussed. We are investigating whether high-dose NAC has therapeutic effects in Chinese patients with early-stage COPD. Method and analysis A randomized, double-blinded, pl

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Ahmad, Faraz S., Iben M. Ricket, Bradley G. Hammill, et al. "Computable Phenotype Implementation for a National, Multicenter Pragmatic Clinical Trial." Circulation: Cardiovascular Quality and Outcomes 13, no. 6 (2020). http://dx.doi.org/10.1161/circoutcomes.119.006292.

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Background: Many large-scale cardiovascular clinical trials are plagued with escalating costs and low enrollment. Implementing a computable phenotype, which is a set of executable algorithms, to identify a group of clinical characteristics derivable from electronic health records or administrative claims records, is essential to successful recruitment in large-scale pragmatic clinical trials. This methods paper provides an overview of the development and implementation of a computable phenotype in ADAPTABLE (Aspirin Dosing: a Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness

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Zhang, Lizi, Miao Hu, Shilei Bi, et al. "TRAPP- Protocol for TRanexamic Acid for the prevention of Postpartum hemorrhage in pregnant women with placenta Previa." Maternal-Fetal Medicine, July 15, 2025. https://doi.org/10.1097/fm9.0000000000000297.

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Abstract Objective: To evaluate the effectiveness of prophylactic tranexamic acid in reducing postpartum hemorrhage (PPH) in high-risk populations, specifically pregnant women with placenta previa, by conducting multicenter randomized controlled trials with sufficient statistical power, in order to establish high-quality evidence for its widespread use in PPH prevention. Methods: This multicenter randomized, double-blind, placeto-controlled trial with two parallel groups will enroll 1680 patients undergoing cesarean delivery with placenta previa. Participants will be randomly assigned to recei

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Zi-yang, Yang, Li Hezhi, Luo Dongling, et al. "Rationale and design of the SPRING trail: effectivity and safety of Pfo closuRe vs medIcine in alleviatiNg migraine, a multicenter, randomized and open-label trail." BMC Cardiovascular Disorders 24, no. 1 (2024). http://dx.doi.org/10.1186/s12872-024-03866-3.

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Abstract Background Migraine is a leading cause of disability worldwide. Several retrospective studies have suggested that the closure of the Patent Foramen Ovale (PFO) may provide relief from migraines. However, three randomized controlled trials did not meet their primary endpoints regarding migraine cessation, reduction in monthly migraine days, and responder rates. Methods The SPRING study is a multicenter, prospective, randomized, and open-label trial designed to compare the effectiveness and safety of PFO closure versus medication in the relief of migraines. The primary endpoint is the t

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Neutel, Céline L. G., Ilaria Viozzi, Christiaan G. Overduin, et al. "Study protocol for a multicenter randomised controlled trial on the (cost)effectiveness of biopsy combined with same-session MR-guided LITT versus biopsy alone in patients with primary irresectable glioblastoma (EMITT trial)." BMC Cancer 23, no. 1 (2023). http://dx.doi.org/10.1186/s12885-023-11282-7.

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Abstract Background Glioblastoma (GBM) is the most common primary, malignant brain tumour with a 5-year survival of 5%. If possible, a glioblastoma is resected and further treated with chemoradiation therapy (CRT), but resection is not feasible in about 30% of cases. Current standard of care in these cases is a biopsy followed by CRT. Magnetic resonance (MR) imaging-guided laser interstitial thermal therapy (LITT) has been suggested as a minimally invasive alternative when surgery is not feasible. However, high-quality evidence directly comparing LITT with standard of care is lacking, precludi

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Klotz, Rémi, Guilhem Emile, Jean-Christophe Daviet, et al. "Daily socket comfort in transtibial amputee with a vacuum-assisted suspension system: study protocol of a randomized, multicenter, double-blind multiple N-of-1 trial." BMC Sports Science, Medicine and Rehabilitation 15, no. 1 (2023). http://dx.doi.org/10.1186/s13102-023-00694-4.

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Abstract Background The main aim of this paper is to present the feasibility of rigorously designed multiple N-of-1 design in prosthetics research. While research of adequate power and high quality is often lacking in rehabilitation, N-of-1 trials can offer a feasible alternative to randomized controlled group trials, both increasing design power at group level and allowing a rigorous, statistically confirmed evaluation of effectiveness at a single patient level. The paper presents a multiple N-of-1 trial protocol, which aim is to evaluate the effectiveness of Unity, a prosthetic add-on suspen

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Wang, Xipeng, Chengqiang Li, Junqiang Fan, Jian Hu, Mingsong Wang, and Hecheng Li. "Safety and effectiveness of using Disposable Ultrasonic shears to coagulate 5–7 mm blood vessels: protocol for a prospective, multicenter, randomized, parallel controlled, non-inferiority clinical trial." BMC Surgery 24, no. 1 (2024). http://dx.doi.org/10.1186/s12893-024-02497-x.

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Abstract Background The ultrasonic scalpel is widely used during surgery. It is safe and effective to close the pulmonary artery branch vessels of 7 mm or below with an ultrasonic energy device as reported. However, there have been no multicenter randomized clinical trial to assess the safety and effectiveness of using ultrasonic scalpel to coagulate 5–7 mm blood vessels in thoracic surgery. Methods This is a prospective, multicenter, randomized, parallel controlled, non-inferiority clinical trial. A total of 144 eligible patients planning to undergo lung or esophageal surgery will be randomly

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Mueller-Stierlin, Annabel Sandra, Thomas Becker, Nils Greve, et al. "Results from a randomized controlled trial investigating effectiveness of a community-based intervention on empowerment of people with severe mental illness." Social Psychiatry and Psychiatric Epidemiology, April 1, 2025. https://doi.org/10.1007/s00127-025-02879-3.

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Abstract Purpose The effectiveness of community mental health services with respect to enhancing empowerment among patients with severe mental illness (SMI) has rarely been investigated. In this multicenter trial the effectiveness of a community mental health intervention (acronym: GBV) added to treatment as usual (TAU) compared to TAU alone was investigated. Methods In a randomized controlled multicenter trial with twelve sites spread across Germany, people living with SMI aged 18–82 years were investigated over 24 months. The trial was conducted from 2020 to 2023, a time period affected by t

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Hall, Tristyn, Amanda Szabo‐Reed, Angela R. Van Sciver, et al. "Effectiveness of Recruitment Sources in a Multicenter Clinical Trial for Dementia Prevention ‐ rrAD study." Alzheimer's & Dementia 19, S22 (2023). http://dx.doi.org/10.1002/alz.077391.

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AbstractBackgroundExercise and Intensive Vascular Risk Reduction in Preventing Dementia (rrAD Study) was a NIH‐funded multisite, clinical trial. The rrAD Study assesses the effects of aerobic exercise training and intensive pharmacological reduction of vascular risk factors on cognitive performance in older adults at high risk for Alzheimer’s disease (AD). The enrollment goal was 640 participants across the span of two years. We report herein our recruitment and enrollment results of the rrAD Study.MethodThe major inclusion criteria were older adults, age 60‐85, who had family history (FH) of

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Slotman, Derk J., Marcia M. T. J. Bartels, Cyril J. Ferrer, et al. "Focused Ultrasound and RadioTHERapy for non-invasive palliative pain treatment in patients with bone metastasis: a study protocol for the three armed randomized controlled FURTHER trial." Trials 23, no. 1 (2022). http://dx.doi.org/10.1186/s13063-022-06942-1.

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Abstract Background Cancer-induced bone pain (CIBP), caused by bone metastases, is a common complication of cancer and strongly impairs quality of life (QoL). External beam radiotherapy (EBRT) is the current standard of care for treatment of CIBP. However, approximately 45% of patients have no adequate pain response after EBRT. Magnetic resonance image-guided high-intensity focused ultrasound (MR-HIFU) may improve pain palliation in this patient population. The main objective of this trial was to compare MR-HIFU, EBRT, and MR-HIFU + EBRT for the palliative treatment of bone metastases. Methods

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Striebich, Sabine, Elke Mattern, Theresa Oganowski, Rainhild Schäfers, and Gertrud Ayerle. "Methodological challenges and solution strategies during implementation of a midwife-led multicenter randomized controlled trial (RCT) in maternity hospitals." BMC Medical Research Methodology 21, no. 1 (2021). http://dx.doi.org/10.1186/s12874-021-01429-0.

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Abstract Background Randomized controlled trials (RCTs), especially multicentric, with complex interventions are methodically challenging. Careful planning under everyday conditions in compliance with the relevant international quality standard (Good Clinical Practice [GCP] guideline) is crucial. Specific challenges exist for RCTs conducted in delivery rooms due to various factors that cannot be planned beforehand. Few published RCTs report challenges and problems in implementing complex interventions in maternity wards. In Germany as well as in other countries, midwives and obstetricians have

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Liu, Linan, Jian Sun, Hu Li, et al. "Fu’s subcutaneous needling approach versus electroacupuncture for knee osteoarthritis: protocol for comparative effectiveness and safety randomized controlled trial." Frontiers in Medicine 12 (May 29, 2025). https://doi.org/10.3389/fmed.2025.1510326.

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IntroductionWith the aging of the population, knee osteoarthritis (KOA) is a common chronic osteoarthritic disorder among middle-aged and elderly people. Fu’s subcutaneous needling (FSN) and electroacupuncture (EA) are both effective means of treating KOA. FSN, with characterized by simple operation, quick effect, safety and green,is a modern acupuncture that integrates modern medicine with traditional acupuncture theory. Our team has demonstrated through clinical trials that FSN can effectively relieve pain and improve walking ability in patients with KOA. However, studies on the difference i

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