Neoadjuvant apatinib addition to sintilimab and carboplatin-taxane based chemotherapy in patients with early triple-negative breast cancer: the phase 2 NeoSAC trial by Guoshuang Shen, Zhilin Liu, Miaozhou Wang, Yi Zhao, Xinlan Liu, Yujin Hou, Wenbiao Ma, Jingqi Han, Xiaofeng Zhou, Dengfeng Ren, Fuxing Zhao, Zitao Li, Shifen Huang, Yongzhi Chen, Yingjian He, Yan Liu, Zijun Zhu, Yongxin Li, Jinming Li, Mengting Da, Hongnan Mo, Feng Du, Liang Cui, Jing Bai, Zhen Liu, Fei Ma, Jiuda Zhao

“…In the phase 2 NeoSAC trial, patients with early TNBC received six cycles of apatinib, sintilimab, nab-paclitaxel, and carboplatin followed by surgery. …”
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Growth, physical, and cognitive function in children who are born HIV-free: School-age follow-up of a cluster-randomised trial in rural Zimbabwe. by Joe D Piper, Clever Mazhanga, Marian Mwapaura, Gloria Mapako, Idah Mapurisa, Tsitsi Mashedze, Eunice Munyama, Maria Kuona, Thombizodwa Mashiri, Kundai Sibanda, Dzidzai Matemavi, Monica Tichagwa, Soneni Nyoni, Asinje Saidi, Manasa Mangwende, Dzivaidzo Chidhanguro, Eddington Mpofu, Joice Tome, Gabriel Mbewe, Batsirai Mutasa, Bernard Chasekwa, Handrea Njovo, Chandiwana Nyachowe, Mary Muchekeza, Kuda Mutasa, Virginia Sauramba, Ceri Evans, Melissa J Gladstone, Jonathan C Wells, Elizabeth Allen, Melanie Smuk, Jean H Humphrey, Lisa F Langhaug, Naume V Tavengwa, Robert Ntozini, Andrew J Prendergast

“…We characterised school-age growth, cognitive and physical function in CBHF and CHU previously enrolled in the Sanitation Hygiene Infant Nutrition Efficacy (SHINE) trial in rural Zimbabwe.<h4>Methods and findings</h4>The SHINE trial enrolled pregnant women between 2012 and 2015 across 2 rural Zimbabwean districts. …”
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Double-blind, randomized, placebo-controlled pilot clinical trial with gamma-band transcranial alternating current stimulation for the treatment of schizophrenia refractory auditory hallucinations by Xiaojuan Wang, Xiaochen Zhang, Yuan Chang, Jingmeng Liao, Shuang Liu, Dong Ming

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The Optimal Intervention Time of Bone Marrow Mesenchymal Stem Cells in Ameliorating Cardiac Fibrosis Induced by Viral Myocarditis: A Randomized Controlled Trial in Mice by Tingting Wu, Yuan Xie, Jing Huang, Ping Li, Xuliang Wang, Yaoyao Yan, Tianhe Xia, Lei Li, Feng Zhu, Hao Li, Rongzhou Wu

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Comment on “Comparison of Diaphragmatic Stretch Technique and Manual Diaphragm Release Technique on Diaphragmatic Excursion in Chronic Obstructive Pulmonary Disease: A Randomized Crossover Trial” by Bruno Bordoni

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Blended digital health intervention for adolescents at high risk with digital media use disorders: protocol for a randomised controlled trial within the Res@t-Consortium by Oliver Labrenz, Oliver Labrenz, Lucie Waedel, Lucie Waedel, Michael Kölch, Michael Kölch, Susanne Lezius, Christina Wacker, Antonia Fröhlich, Antonia Fröhlich, Kerstin Paschke, Rainer Thomasius, Olaf Reis, Olaf Reis

“…The efficacy of the app will be evaluated in a randomised controlled trial with a waitlist control group. The primary outcome is the reduction of DMUD symptoms over a 20-week period following the onset of app training. …”
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Effectiveness of Mobile Health–Based Gamification Interventions for Improving Physical Activity in Individuals With Cardiovascular Diseases: Systematic Review and Meta-Analysis of Randomized Controlled Trials by Tianzhuo Yu, Monica Parry, Tianyue Yu, Linqi Xu, Yuejin Wu, Ting Zeng, Xin Leng, Qian Tong, Feng Li

“…MethodsA comprehensive search of 7 electronic databases was conducted for randomized controlled trials published in English from January 1, 2010, to February 3, 2024. …”
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Efficacy and safety of jaktinib hydrochloride tablets in active axial spondyloarthritis: a multicentre, randomised, double-blind, placebo-controlled phase II clinical trial by Xiaomei Li, Xiaoxia Wang, Jian Wu, Xiao Zhang, Chunde Bao, Shengqian Xu, Lingyun Sun, Juan Wang, Guixiu Shi, Xiaofei Wang, Qing Dai, Antao Xu, Huaxiang Wu, YongQing Wang, Yan Ye, Yongfu Wang, Huaxiang Liu, Chenyin Lv, Jun Miao, Weiqi Min, Kuanting Wang, Luan Xue, Shanhui Ye

“…No major adverse cardiovascular events, malignancy, thromboembolism or deaths were reported.Conclusions Jaktinib showed good efficacy and tolerability in the treatment of active r-axSpA, with the 100 mg two times per day showing a trend towards better efficacy.Trial registration number NCT04507659.…”
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Persistence of gastrointestinal symptoms in irritable bowel syndrome and ulcerative colitis: study protocol for a three-arm randomised controlled trial (SOMA.GUT-RCT) by Ansgar W Lohse, Bernd Löwe, Kerstin Maehder, Yvonne Nestoriuc, Antonia Zapf, Eik Vettorazzi, Viola Andresen, Sina Hübener, Luisa Peters

“…Furthermore, the detailed analysis of the complex biopsychosocial mechanisms will allow the further advancement of aetiological models and according evidence-based intervention strategies.Trial registration number ISRCTN30800023.…”
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Impact of Preventive Intravenous Amiodarone on Reperfusion Ventricular Fibrillation in Patients With Left Ventricular Hypertrophy Undergoing Open-Heart Surgery: Randomized Controlled Clinical Trial by Chan-Juan Gong, Xiao-Kai Zhou, Zhen-Feng Zhang, Yin Fang

“…Thirty minutes before removal of the ACC, the trial drugs were administered intravenously. In group A, 150 mg of amiodarone was pumped in 15 minutes. …”
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Biomarkers of pembrolizumab efficacy in advanced anal squamous cell carcinoma: analysis of a phase II clinical trial and a cohort of long-term responders by Jeffrey A Meyerhardt, Sunil Kumar, Jessica A Zerillo, Aparna Parikh, James M Cleary, Scott Rodig, Benjamin Schlechter, Kimmie Ng, Stephanie K Dougan, Nora Horick, Glenn J Hanna, Andrew L Coveler, Anuj K Patel, Nadine J McCleary, Douglas A Rubinson, Jeffrey W Clark, Kent Mouw, Kathleen Pfaff, Thomas A Abrams, Matthew B Yurgelun, Eliezer M Van Allen, S Jennifer Wang, Leah H Biller, Harshabad Singh, Emma L Welsh, Brandon M Huffman, Lestat R Ali, Megan T Hoffman, Katherine A Metayer, Shayla Murray, Alexandra Bird, Jennifer A Chan, Wolfram Goessling, Jeffrey S Wisch, Brendan Reardon, Robert J Mayer, Catherine Del Vecchio Fitz, Charlotte Kuperwasser

“…Background Recent trials suggest that programmed cell death 1 (PD-1)-directed immunotherapy may be beneficial for some patients with anal squamous cell carcinoma and biomarkers predictive of response are greatly needed.Methods This multicenter phase II clinical trial (NCT02919969) enrolled patients with metastatic or locally advanced incurable anal squamous cell carcinoma (n=32). …”
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Insufficient Evidence to Recommend Shu Mian Capsule in Managing Depression With or Without Comorbid Insomnia: A Systematic Review With Meta-Analysis and Trial Sequential Analysis by Zhao FY, Xu P, Kennedy GA, Jin X, Wang YM, Zhang WJ, Yue LP, Ho YS, Fu QQ, Conduit R

“…Additionally, 92.9% of trials lacked follow-ups.Conclusion: The effectiveness of SMC as an alternative to conventional antidepressive treatment is unclear. …”
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Effect of Dipeptidyl Peptidase-4 (DPP-4) Inhibition on Biomarkers of Kidney Injury and Vascular Calcification in Diabetic Kidney Disease: A Randomized Controlled Trial by Thananda Trakarnvanich, Bancha Satirapoj, Swangjit Suraamornkul, Thanit Chirananthavat, Anoma Sanpatchayapong, Torpong Claimon

“…A larger study with a longer follow-up is essential to verify these beneficial effects. Clinical Trials. This trial is registered with ClinicalTrials.Gov Identifier NCT04705506.…”
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The Effect of Zinc Supplementation on Glycemic, Weight, and Blood Pressure Control in Patients With Type 2 Diabetes Mellitus: A Double‐Blind Randomized Controlled Trial by Mehrab Sayadi, Sara Javadpour Nowbandegani, Fatemeh Balaghi Inalou, Bahman Nazemzadegan, Shirzad Javidi Alsaadi, Mohammadreza Eskandari, Matin Sepehrinia

“…Conclusion Taking 220 mg of zinc sulfate supplement twice a week did not show significant benefit for weight, blood pressure, and glycemic control in patients with Type 2 diabetes. Trial Registration This trial was registered on the Iranian Registry of Clinical Trials (IRCT) website with code number 29627 on September 18, 2018.…”
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Economic and relationship-strengthening intervention to reduce alcohol use in couples living with HIV in Malawi: a study protocol for a randomised controlled trial of Mlambe by Torsten B Neilands, Lynae A Darbes, James Mkandawire, Derek S Brown, Fred M Ssewamala, Judith A Hahn, Amy A Conroy, Nancy Mulauzi, Scott Tebbetts

“…Results will be disseminated to study participants, local health officials and HIV policy makers and through presentations at conferences and publications in peer-reviewed journals.Trial registration number ClinicalTrials.gov Protocol Registration; NCT06367348 registered on 19 April 2024; https://register.clinicaltrials.gov/. …”
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Equality, Diversity and Inclusion characteristics measured or reported in randomised trials of intrapartum interventions: A Scoping Review [version 1; peer review: 2 approved] by Aoife Smith, John Gilmore, Susan Hannon, Valerie Smith

“…As a preliminary exploration for future discussion and development, we undertook a scoping review to identify the types, frequency, and extent of EDI characteristics that were measured and reported in randomised controlled trials (RCTs) of intrapartum interventions specifically. …”
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Pre-IVF treatment with a GnRH antagonist in women with endometriosis (PREGNANT): study protocol for a prospective, double-blind, placebo-controlled trial by Hugh Taylor, Hao Huang, Lubna Pal, Heping Zhang, Howard J Li, Sandra Carson, Valerie Flores, Jared Robbins, Nanette F Santoro, James H Segars, David Seifer, Steven Young

“…Results will be published in a peer-reviewed journal.Trial registration number NCT04173169.…”
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Safety and efficacy of trifluridine/tipiracil +/− bevacizumab plus XB2001 (anti-IL-1α antibody): a single-center phase 1 trial by Marion Thibaudin, Nicolas Roussot, Chloé Burlot, Antonin Schmitt, Julie Vincent, Zoé Tharin, Leila Bengrine, Hélène Bellio, Aurélie Bertaut, Léa Hampe, Susy Daumoine, Emilie Rederstorff, Morgane Peroz, Titouan Huppe, Valentin Derangère, David Rageot, John Simard, Caroline Truntzer, Jean David Fumet, Francois Ghiringhelli

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An mHealth Intervention With Financial Incentives to Promote Smoking Cessation and Physical Activity Among Black Adults: Protocol for a Feasibility Randomized Controlled Trial by Adam Alexander, Michael Businelle, Marshall Cheney, Amy Cohn, Lorna McNeill, Kevin Short, Summer Frank-Pearce, David Bradley, Kimberly Estrada, Iván Flores, Jack Fronheiser, Darla Kendzor

“…Trial RegistrationClinicalTrials.gov NCT05188287; https://clinicaltrials.gov/ct2/show/NCT05188287 International Registered Report Identifier (IRRID)PRR1-10.2196/69771…”
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Analgesic Characteristics of Bupivacaine Alone and in Combination with Dexmedetomidine or Meperidine in Spinal Anesthesia during Cesarean Section: A Double-Blind Randomized Clinical Trial Study by Simin Azemati, Amir Zarghami, Reza Jouybar, Vida Naderi-boldaji

“…In this double-blind randomized clinical trial study, ninety pregnant women were divided into groups to receive 10 mg bupivacaine (group B), 10 mg bupivacaine with 5 μg dexmedetomidine (group BD), or 10 mg bupivacaine with 10 mg meperidine (group BM) intrathecal. …”
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