Long-term efficacy and safety of alemtuzumab in participants with highly active MS: TOPAZ clinical trial and interim analysis of TREAT-MS real-world study by Tjalf Ziemssen, Ann D. Bass, Bart Van Wijmeersch, Sara Eichau, Stephan Richter, Frank Hoffmann, Nicole M. Armstrong, Magdalena Chirieac, Janete Cunha-Santos, Barry A. Singer

“…Sustained efficacy up to 9 years was observed in the phase IIIb/IV open-label TOPAZ clinical trial and assessed in the real-world retrospective and prospective study, TREAT-MS. …”
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A Pragmatic Clinical Trial to Compare the Real-World Effectiveness of V-Go versus Standard Delivery of Insulin in Patients with Advanced Type 2 Diabetes by Mark J. Cziraky, Scott Abbott, Matt Nguyen, Kay Larholt, Elizabeth Apgar, Thomas Wasser, Poul Strange, Leon Shi, H. Courtenay Harrison, Beverly Everitt, Lynn Nowak

“…**Objective:** This prospective pragmatic clinical trial evaluated V-Go, a wearable insulin delivery device, compared with standard treatment optimization (STO) among insulin-treated patients with T2DM in a realworld, community-based practice setting. …”
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Acute and chronic effects of physical exercise on atherosclerosis, kynurenine pathway, endothelial function and inflammation in patients with coronary artery disease: a clinical trial protocol by Eliete Bouskela, Gabriela Andrade Paz, Marcus VDS Rangel, Caio Luan Farias, André Luiz Conveniente Soares, Erica Langner, Tatiana Teixeira, Patrícia M L Dutra, Paulo Farinatti, Maria das Graças C Souza, Juliana P Borges

“…This study was approved by the Ethics Committee of Pedro Ernesto University Hospital (CAAE 81718324.3.0000.5259) and registered on ClinicalTrials.gov (NCT06579807). Dissemination of the findings will include peer-reviewed publications, conference presentations and media releases.…”
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Health-Related Quality-of-Life Utility Values in Adults With Late-Onset Pompe Disease: Analyses of EQ-5D Data From the PROPEL Clinical Trial by Alison Griffiths, Simon Shohet, Neil Johnson, Alasdair MacCulloch

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Effect of remote ischemic preconditioning on perioperative neurocognitive disorder in elderly patients undergoing major surgery and associated genetic variant analysis: a randomized clinical trial by Feifei Xu, Tingting Liu, Huiqing Liu, Jiao Deng, Shan He, Zhihong Lu, Haopeng Zhang, Hailong Dong

“…Trial registration. Chinese Clinical Trial Registry (ChiCTR2000035020(07/28/2020)).…”
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Effect of Low Dose Aspirin in Low Risk Pregnant Ladies with Abnormal Uterine Artery Doppler Results, and the Evaluation of Maternal and Fetal outcomes: A Randomized Clinical Trial by Parzhin Jalal Ali, Chro Najmaddin Fattah

“…Patients and Methods: A randomized clinical trial was performed on 50 pregnant ladies (?16 weeks of gestation) in Sulaymaniyah Maternity Teaching Hospital during January 2017 to January 2018. …”
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Evaluation of patient comfort and satisfaction after the surgical removal of mandibular impacted molars using a piezo-electric technique: A randomized double-blind clinical trial by Khalid Zabin Alotaibi, Waleed Mohammed Al Rasheed, Jiingade Krishnojirao Dayashankara Rao, Abdulrahman Altwaijri, Gharam Mefleh Alharbi, Shatha saleh Aljaber

“…Abstarct: Introduction: This is a double clinical trial conducted to study the patient satisfaction and comfort during and after surgical removal of impacted mandibular 3rd molar using Piezo electric tips. …”
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The effect of probiotic-fortified kefir on depression, appetite, oxidative stress, and inflammatory parameters in Iranian overweight and obese elderly: a randomized, double-blind, placebo-controlled clinical trial by Mehran Noori, Zainab Shateri, Siavash Babajafari, Mohammad Hadi Eskandari, Karim Parastouei, Mohammad Ghasemi, Hoseein Afshari, Mohammad Samadi

“…Methods This study was a double-blind, randomized, and placebo-controlled clinical trial conducted on 67 elderly men aged over 65, who were randomly divided into two groups. …”
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Improving neuroendocrine tumor treatments with mathematical modeling: lessons from other endocrine cancers by John Metzcar, Rachael Guenter, Yafei Wang, Kimberly M Baker, Kate E Lines

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Requirements and special considerations for drug trials with children across six jurisdictions: 2. Ethics review in the regulatory approval process by Breanne Stewart, Pirkko Lepola, Gunter F. Egger, Fahimeda Ali, Albert J. Allen, Albert J. Allen, Alysha K. Croker, Andrew J. Davidson, Pamela Dicks, Saul N. Faust, Saul N. Faust, Dionna Green, Collin Hovinga, Collin Hovinga, Agnes V. Klein, Robyn Langham, Hidefumi Nakamura, Laura Pioppo, Shiva Ramroop, Michiyo Sakiyama, Isabel Sanchez Vigil de la Villa, Junko Sato, Donna L. Snyder, Mark A. Turner, Mark A. Turner, Sarah Zaidi, Kanecia Zimmerman, Kanecia Zimmerman, Thierry Lacaze-Masmonteil

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A comparison of the efficacy of the effect of online versus face-to-face group counseling based on positive-approach on sexual intimacy of women after benign abdominal hysterectomy: a clinical trial by Orly Nazanin Kalimi, Tayebeh Mokhtari Sorkhani, Ali Dehghani, Mahshid Bokaie

“…Iranian Registry of Clinical Trials - IRCT20230209057373N1…”
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The Effect of Whey Protein Consumption on Postprandial Glucose, Insulin and Incretin Responses in Patients with Type 2 Diabetes: A Systematic Review and Meta-Analysis of Acute-Term Controlled Clinical Trials by Zahra Salimi, Maryam Asadi, Anahita Mansoori

“…Methods: Web of Science, Cochrane Library, EMBASE, PubMed, and Scopus databases were searched to find acute-term controlled clinical trials investigating the effect of all types of whey proteins on products postprandial glucose (PPG) response as the main outcome and also insulin and incretin responses as secondary outcomes in patients with T2DM. …”
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Beneficial and harmful effects of duloxetine versus placebo, ‘active placebo’ or no intervention for adults with major depressive disorder: a systematic review with meta-analysis and trial sequential analysis of randomised clinical trials by Christian Gluud, Marija Barbateskovic, Joanna Moncrieff, Faiza Siddiqui, Janus C Jakobsen, Mathias Maagaard, Sophie Juul, Johanne Juul Petersen, Caroline Barkholt Kamp, Mark Abie Horowitz, Kiran Kumar Katakam

“…We requested clinical study reports from 36 competent authorities.Eligibility criteria for selecting studies All randomised clinical trials comparing duloxetine versus placebo, ‘active placebo’ or no intervention, irrespective of publication type, publication status, publication year and language for treatment of major depressive disorder in adults.Data extraction and synthesis Five authors in pairs extracted data using a standardised data extraction sheet. …”
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Psilocybin-assisted therapy for reducing alcohol intake in patients with alcohol use disorder: protocol for a randomised, double-blinded, placebo-controlled 12-week clinical trial (The QUANTUM Trip Trial) by Claus Thorn Ekstrøm, Patrick MacDonald Fisher, Gitte Moos Knudsen, Dea Siggaard Stenbæk, Anders Fink-Jensen, Mathias Ebbesen Jensen, Tobias Søgaard Juul

“…However, the efficacy of a single psilocybin administration and its potential neurobiological underpinnings still remain unknown.Methods and analysis To establish efficacy, we will investigate the effects of psilocybin-assisted therapy versus placebo in a randomised, double-blinded, placebo-controlled 12-week clinical trial. Ninety treatment-seeking patients, aged 20–70 years, diagnosed with alcohol use disorder will be recruited from the community via advertisement and referrals from general practitioners or specialised treatment units. …”
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Effect of Weight-Loss Diet Combined with Taurine Supplementation on Fasting Levels of Fibroblast Growth Factors19, 21, and 𝛃-klothoCo-Receptor in Obese Women: A Randomized Clinical Trial by Maryam Asadi, Fatemeh Haidari, Hossein Bavi Behbahani, Maryam J Chitsazi, Javad Mohammadi-asl, Kambiz Ahmadi-Angali

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Hypofractionated radiotherapy combined with a PD-1 inhibitor, granulocyte macrophage-colony stimulating factor, and thymosin-α1 in advanced metastatic solid tumors: a multicenter Phase II clinical trial by Jiamin Yu, Li Yin, Wenjie Guo, Qiang Wang, Juying Liu, Lansheng Zhang, Hongxun Ye, Jianhong Xia, Youyou Xia, Jianfeng Wu, Wanwei Wang, Yanguang Yang, Dan Zong, Xia He, Lijun Wang, Hong Jiang

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TARGET Protein: the effect of augmented administration of enteral protein to critically ill adults on clinical outcomes—statistical analysis plan for a cluster randomized, cross-sectional, double cross-over, clinical trial by Sophie Zaloumis, Matthew J. Summers, Jeffrey J. Presneill, Rinaldo Bellomo, Lee-anne S. Chapple, Marianne J. Chapman, Adam M. Deane, Suzie Ferrie, Craig French, Sally Hurford, Nima Kakho, Matthew J. Maiden, Stephanie N. O’Connor, Sandra L. Peake, Emma J. Ridley, An Tran-Duy, Patricia J. Williams, Paul J. Young, Amalia Karahalios, on behalf of the TARGET Protein Investigators, the Australian, New Zealand Intensive Care Society Clinical Trials Group

“…Trial registration Australian New Zealand Clinical Trials Registry (ACTRN12621001484831). Registered on November 1, 2021.…”
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Building a diverse national research advisory board by Gayle Valensky, Jeff B. Pawelek, Lauren Serpico, David Rodriguez, Maribel Pieters, Yulissa Perez, Julia Moore Vogel

Subjects: “…diversity and inclusion in clinical trials…”
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Efficacy and safety of glycyrrhizic acid and essential phospholipids (Phosphogliv) combination for alcoholic liver disease: results of the double-blind randomized placebo-controlled multicenter post-registration (phase IV) clinical trial «Jaguar» (PHG-M2/P03-12) by I. G. Bakulin, N. A. Bokhan, P. O. Bogomolov, N. I. Geyvandova, M. V. Matsiyevich, M. A. Vinnikova, V. G. Morozov, O. M. Khromtsova, G. S. Soldatova, O. Yu. Shiryayev, R. D. Ilyuk, K. V. Rybakova, A. G. Katkovskaya, S. V. Teplykh, A. A. Bagretsova, M. V. Krasnova, Ye. V. Alekseyeva, A. V. Anipchenko, Ye. V. Baskakov

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Low & Anaplastic Grade Glioma Umbrella Study of MOlecular Guided TherapieS (LUMOS-2): study protocol for a phase 2, prospective, multicentre, open-label, multiarm, biomarker-directed, signal-seeking, umbrella, clinical trial for recurrent IDH mutant, grade 2/3 glioma by Marshall Pitz, Eng-Siew Koh, Elizabeth H Barnes, Lucille Sebastian, Mandy L Ballinger, David M Thomas, Christopher O'Callaghan, John Simes, Hui K Gan, Sonia Yip, Hao-Wen Sim, Desma Spyridopoulos, Richard De Abreu Lourenco, Cynthia Hawkins, Kristen McParland, Benjamin Kong, Subotheni Thavaneswaran, Patrick J Wheeler

“…This study aims to improve outcomes by molecular profiling of patients at relapse, then matching them with the best available drug based on their molecular profile, maximising the chances of patient benefit while simultaneously testing multiple novel drugs.Methods and analysis Low & Anaplastic Grade Glioma Umbrella Study of MOlecular Guided TherapieS (LUMOS-2) will be an international, phase 2, multicentre, open-label, biomarker-directed, umbrella clinical trial for recurrent isocitrate dehydrogenase mutant, histologically grade 2/3 gliomas. …”
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