A multi-center, international, randomized, 2-year, parallel-group study to assess the superiority of IVUS-guided PCI versus qualitative angio-guided PCI in unprotected left main co... by Giovanni Luigi De Maria, Luca Testa, Jose M de la Torre Hernandez, Dimitrios Terentes-Printzios, Maria Emfietzoglou, Roberto Scarsini, Francesco Bedogni, Ernest Spitzer, Adrian Banning

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Protocol for a multicentre, randomised, parallel-control, superiority trial comparing administration of clotting factor concentrates with a standard massive haemorrhage protocol in... by Neil Parry, Andrew Beckett, Jo Carroll, Homer Tien, Jeannie Callum, Andrew Petrosoniak, Damon Scales, Luis Teodoro da Luz, Keyvan Karkouti, Paul T Engels, Hans-Peter Hucke, Deep Grewal, Bruce Schwartz, Henry Peng

“…However, there is a knowledge gap on their use compared with the standard of care, the transfusion of plasma.Methods and analysis The factors in the initial resuscitation of severe trauma 2 trial is a multicentre, randomised, parallel-control, single-blinded, phase IV superiority trial. …”
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A single-centre investigator-blinded randomised parallel group clinical trial to investigate the effect of probiotic strains Streptococcus salivarius M18 and Lactobacillus acidophi... by Eleftherios G Kaklamanos, Rania Nassar, Sotirios Kalfas, Manal Al Halabi, Mawlood Kowash, Haifa Hannawi, Iyad Hussein, Anas Salami, Ammar Hassan, Abiola C Senok

“…Study findings will be disseminated via publication in peer-reviewed journal.Trial registration number ISRCTN95085398…”
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Effects of switching from a dipeptidyl peptidase-4 inhibitor to oral semaglutide on glucose metabolism in patients with type 2 diabetes: protocol for a multicentre, prospective, ra... by Kyu Yong Cho, Hiroki Yokoyama, Tatsuya Atsumi, Hiroshi Nomoto, Jun Takeuchi, So Nagai, Yoshio Kurihara, Shin Aoki, Akinobu Nakamura, Hideaki Miyoshi, Shinji Taneda, Ichiro Sakuma, Sho Furusawa, Aika Miya, Hiraku Kameda

“…Hokkaido University Certified Review Board (CRB no.1180001) has approved the protocol (no. 020–013).Trial registration number UMIN000045270 in the University Hospital Medical Information Network; jRCT1011210032 in the Japan Registry of Clinical Trials.…”
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Effectiveness of a mindfulness-based intervention + standard diet treatment compared to standard diet treatment alone on food cravings in overweight/obese individuals with mild to... by Seyed Amirhossein Allameh, Zeinab Mokhtari, Gholamreza Askari

“…Registration code: IRCT20210507051204N2.…”
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Efficacy and safety of high-dose Xueshuantong injection (lyophilised) in reducing the incidence of major adverse cardiovascular events in patients with unstable angina: a protocol... by Xi Huang, Weiji Lin, Wenjie Long, Huili Liao, Qingqing Liu, Yaqing Tang, Jianhong Liu, Tianhui Yuan, Yan Ling, Yu Hong, Jiao Duan, Shaoxiang Xian, Zhongqi Yang

“…This clinical trial aims to examine the efficacy and safety of XST.Methods and analysis This is a randomised, parallel-arm, controlled, double-blind and multicentre clinical trial. …”
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Efficacy of yeast beta-glucan 1,3/1,6 supplementation on respiratory infection, fatigue, immune markers and gut health among moderate stress adults in Klang Valley of Malaysia: pro... by Suzana Shahar, Kalavathy Ramasamy, Norhayati Ibrahim, Nur Nadia Mohamad Habibullah, Munirah Ismail, Mohd Zul Amin Kamaruddin, Shirley Gee Hoon Tang, Mohd Faisal Abdul Hamid

“…The findings will be disseminated to participants, healthcare professionals and researchers via conference presentations and peer-reviewed publications.Trial registration number ISRCTN48336189…”
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Investigation of the effects of combined exercises and self-management education, with and without functional exercises, on pain and functional outcomes in patients with avascular... by Zohreh Gholami, Seyedeh Tahereh Faezi, Elham Madreseh, Raghad Mimar

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Combined use of a broad-panel respiratory multiplex PCR and procalcitonin to reduce duration of antibiotics exposure in patients with severe community-acquired pneumonia (MULTI-CAP... by Isabelle Durand-Zaleski, Eric Maury, Bruno Megarbane, Tabassome Simon, Jean-François Timsit, Jean Dellamonica, Saad Nseir, Alexandra Rousseau, Laurence Bérard, Kada Klouche, Yacine Tandjaoui-Lambiotte, Jean Reignier, Laurent Argaud, Muriel Fartoukh, Keyvan Razazi, Laurence Armand-Lefevre, Bertrand Souweine, Guillaume Voiriot, Charlotte Verdet, Juliette Patrier, Jean-Christophe Richard, Carole Schwebel, Jean-Christophe Navellou, Pierre-Francois Dequin, Pierre-Edouard Bollaert, Marc Gainnier, Julien Bohe

“…The results will be disseminated through educational institutions, submitted to peer-reviewed journals for publication and presented at medical congresses.Trial registration number NCT03452826; Pre-results.…”
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Reducing intraoperative hemorrhage in type II caesarean scar pregnancy: a study protocol comparing high-intensity focused ultrasound (HIFU) pretreatment vs. hysteroscopy-guided suc... by Changmei Sang, Qiuling Shi, Lei Zhao, Yanjun Kang, Shuping Zhao, Zhibiao Wang

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RELAX (REducing Levels of AnXiety): a study protocol for a parallel two-arm randomised controlled trial evaluating a web-based early intervention for pregnant women with high level... by Brittannia Volkmer, Yogini Sawjani, Mary Newburn, Jo Bennett, Megan McGovern, Laura Bridle, Nathalie Towner, Laura McCabe, Katherine Clark, Sophie Webster, Alison Hylton-Potts, Lucy Mayer, Gertrude Senevirante, Debra Bick, Jill Newby, Kimberley Goldsmith, Michelle L. Moulds, Colette Hirsch

“…RNT is maintained by the tendency to generate negative interpretations of ambiguous situations. Methods A parallel two-arm randomised controlled trial will assess the efficacy of adding interpretation training (RELAX) to usual maternity care. …”
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Interventions to enable and reach patients with heart failure and their caregivers, with palliative care (TIER-HF-PC): a study protocol of a two-armed parallel group, open label ra... by Yin Bun Cheung, Shirlyn Hui-Shan Neo, Ke Yu, Chun Fan Lee

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Optimisation of Organ Preservation treatment strategies in patients with rectal cancer with a good clinical response after neoadjuvant (chemo)radiotherapy: Additional contact X-ray... by Jacobus W A Burger, Geerard L Beets, Corrie A M Marijnen, Femke P Peters, Brechtje A Grotenhuis, Jeltsje S Cnossen, Monique Maas, Barbara M Geubels, Baukelien van Triest, Petra A Custers, Harm J T Rutten, Jaqueline C M Theuws, An-Sofie E Verrijssen

“…The trial results will be published in an international peer-reviewed journal.Trial registration number NCT05772923.…”
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Safety and immunogenicity of heterologous boosting with orally administered aerosolized bivalent adenovirus type-5 vectored COVID-19 vaccine and B.1.1.529 variant adenovirus type-5... by Jia-Wei Xu, Bu-Sen Wang, Ping Gao, Hai-Tao Huang, Fei-Yu Wang, Wei Qiu, Yuan-Yuan Zhang, Yu Xu, Jin-Bo Gou, Lin-Ling Yu, Xuan Liu, Rui-Jie Wang, Tao Zhu, Li-Hua Hou, Qing- Wang

“…Overall, the investigational vaccines were demonstrated to be safe and well tolerated in adults, and was highly effective in inducing mucosal immunities in addition to humoral and cellular immune responses defending against SARS-CoV-2 variants.Trial registration: Chictr.org identifier: ChiCTR2200063996.…”
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Support on four paws—does the integration of a therapy dog reduce anxiety and increase positive affect in spider phobics during in vivo exposure therapy?: study protocol for a para... by Tanja Michael, Moritz Nicolai Braun, Monika Equit, Johanna Lass-Hennemann

“…Following common open science practices, data and analysis code will also be made publicly available in anonymised form on the Open Science Framework (osf.io).Trial registration number On 18 June 2024, this study was registered at the German Clinical Trials Register (ID: DRKS00034494; https://drks.de/search/de/trial/DRKS00034494) and preregistered at AsPredicted (https://aspredicted.org/JRP_SCF).…”
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A comparative study of the procedures for medicine approval in the European Union and the United States by Gjeorgiev Blagoj, Miceva Dijana, Karpicarov Dino, Apostolova Paulina, Bogevski Krume, Arev Marija, Gjorgjeska Biljana

“…Efforts to harmonize procedures, such as the FDA-EMA Parallel Scientific Advice program and the Mutual Recognition Agreement, aim to enhance alignment and reduce development resources, creating a global regulatory environment to streamline the registration of new medicines.…”
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Delineating the Development of English episcopal chanceries through the Signification of Excommunication by Philippa Hoskin

“…The structure of episcopal registers developed in parallel with the use of common form, revealing chanceries still in flux and that those dioceses with the earliest registers were not necessarily the most organised by the start of the fourteenth century.…”
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Implementation of negative pressure for acute pediatric burns (INPREP): A stepped-wedge cluster randomized controlled trial protocol. by Maleea D Holbert, Fiona Wood, Andrew J A Holland, Warwick Teague, Roy M Kimble, Dianne Crellin, Cody C Frear, Kristen Storey, Natalie Phillips, Yvonne Singer, Tanesha A Dimanopoulos, Lisa Martin, Leila Cuttle, Dimitrios Vagenas, Steven M McPhail, Pauline Calleja, Jed Duff, Alexandra De Young, Bronwyn R Griffin

“…<h4>Trial registration</h4>Australian and New Zealand Clinical Trials Registry: ACTRN12622000166774. …”
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Effects of oral care combined with neuromuscular electrical stimulation on clinical outcomes in the acute phase of acute ischemic stroke: a pilot randomized controlled trial by Yi-Ting Huang, Chia-Chun Tang, Chen-Chih Chung, Chi-Hsiang Chung

“…Larger, blinded, multi-center trials are warranted to further evaluate the efficacy and broader applicability of this early intervention strategy. Registration The study protocol was registered in the Protocol Registration and Results System (PRS) under ID N202108021 as a supplementary registration due to initial unfamiliarity with PRS registration requirements, with the registration date recorded as 11/14/2024.…”
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Effect of single-dose diode laser photobiomodulation on orthodontic pain following initial archwire placement: a randomized clinical trial by Amin Golshah, Azadeh Kazemisaleh, Fatemeh Azizi, Amin Hossein Nejad

“…Retrospectively registered. Registration date: 08/07/2023.…”
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