The SmartNTx-study: a prospective, randomized controlled trial to investigate additional interventional telemedical management versus standard aftercare in kidney transplant recipi... by Mario Schiffer, Lars Pape, Julia K. Wolff, Julia K. Wolff, Raoul Gertges, Vanessa Visconti, Karen Reichert, Anja Pfau, Anne Dieterle, Katja Sauerstein, Andreas Kribben, Kristina Boss, Sinem Karaterzi, Felix Nensa, Philipp Winneckens, Mario Cypko, Mario Cypko, Wiebke Duettmann, Bianca Zukunft, Eva Schrezenmeier, Marcel G. Naik, Fabian Halleck, Roland Roller, Sebastian Möller, Sebastian Möller, Oliver Amft, Oliver Amft, Klemens Budde

“…Therefore, a composite endpoint of seven key outcome variables [fewer hospitalizations, shorter length of hospitalization, less development of de novo donor-specific antibody (DSA), better medication adherence, lower tacrolimus intra-patient variability, better blood pressure control, and better renal function after kidney transplantation]was defined. …”
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One-year outcomes in sepsis: a prospective multicenter cohort study in Japan by Keibun Liu, Shinichi Watanabe, Kensuke Nakamura, Hidehiko Nakano, Maiko Motoki, Hiroshi Kamijo, Matsuoka Ayaka, Kenzo Ishii, Yasunari Morita, Takashi Hongo, Nobutake Shimojo, Yukiko Tanaka, Manabu Hanazawa, Tomohiro Hamagami, Kenji Oike, Daisuke Kasugai, Yutaka Sakuda, Yuhei Irie, Masakazu Nitta, Kazuki Akieda, Daigo Shimakura, Hajime Katsukawa, Toru Kotani, David McWilliams, Peter Nydahl, Stefan J. Schaller, Takayuki Ogura, the ILOSS Study Group

“…The aim was to present detailed data on the prognostic and functional long-term outcomes of ICU patients with sepsis in Japan, which is currently lacking and therefore prevents development of targeted solutions. Methods A multicenter prospective study, involving 21 ICUs in 20 tertiary hospitals in Japan, included all consecutive adult ICU patients between November 2020 and April 2022, and diagnosed with sepsis at ICU admission (Sepsis 3). …”
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Phase I study of efineptakin alfa (NT-I7) for the treatment of Kaposi sarcoma by Leonard D’Amico, Martin Cheever, Steven P Fling, Anna Wright, Kathryn Lurain, Ramya Ramaswami, Irene Ekwede, Thomas S Uldrick, Robert Yarchoan, Judith C Kaiser, Angela Shaulov Kask, Manoj P Menon, Paul Couey, Eli Burnham, Allysson Angeldekao, Byung Ha Lee, Li-Lian Kwok, Chia-Ching Jackie Wang

“…IL-7 is a cytokine that is essential in T-cell development, proliferation and homeostasis. In PWH, IL-7 administration leads to increased numbers of circulating central memory and naïve T-cell phenotypes.Methods In this multicenter phase I study with a 3+3 dose escalation design, participants with KS with or without HIV received up to four intramuscular injections of IL-7 (NT-I7) every 9 weeks. …”
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Assessing the efficacy of 3D window double screens (3D-WDS) in reducing malaria transmission in northeastern Tanzania: Study protocol for a two-arm cluster-randomised controlled tr... by William N. Kisinza, Subam Kathet, Victor Mwingira, Maija Meri, Frank S. Magogo, Veneranda M. Bwana, Hanna Granroth-Wilding, Pendael Machafuko, Patrick Tungu, Mikko Aalto, Tomi Hakala, Markku Honkala, Seppo Meri, Ayman Khattab

“…Findings from this trial will demonstrate its real-world effectiveness and contribute to the development of scalable, long-term strategies for malaria prevention. …”
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Evaluation of potential biomarkers during irinotecan-based systemic treatment for colorectal cancer—study protocol of the OPTIMA study by E. Russ, J. Ziemons, L. E. Hillege, S. M. J. van Kuijk, E. M. de Jong, C. Elbers, M. J. Deenen, L. H. Borghuis, T. M. M. Böhm, P. Kristen, L. C. Valk, I. E. G. van Hellemond, H. Vestjens, A. Dietvorst, A. Baars, A. N. M. Goosens, L. Vermeulen, T. E. Buffart, J. de Vos-Geelen, J. Penders, M. R. Redinbo, L. Valkenburg-van Iersel, M. L. Smidt

“…Moreover, the UGT1A1 genotype of the patient, and the activity of the gut microbial enzyme β-glucuronidase (GUS) have been suggested as biomarkers for the development of systemic (e.g. neutropenia) and gastrointestinal toxicity (e.g. diarrhea) respectively. …”
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Hepatic artery infusion chemotherapy combined with camrelizumab and apatinib as conversion therapy for patients with unresectable hepatocellular carcinoma: a single-arm exploratory... by Kugeluke Yalikun, Zhongchao Li, Jianxin Zhang, Zhibin Chang, Mingming Li, Zhicheng Sun, Zhaogang Liu, Yue Yang, Lei Xu, Lei Li, Chengsheng Zhang, Pengfei Sun, Jingtao Zhong, Kai Cui, Xuetao Shi, Bo Zhang, Lei Zhao

“…Abstract Background The development of systemic therapy, including targeted drugs and immune checkpoint inhibitors, has significantly improved the prognosis of patients with advanced unresectable hepatocellular carcinoma (uHCC). …”
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Phase 1b/2 study evaluating safety, efficacy and immune effects of TLR9 agonist cavrotolimod with anti-PD-1 antibodies among patients with advanced solid tumors by Douglas E Feltner, Adil Daud, Brent A Hanks, Shailender Bhatia, Michael K Wong, Sunandana Chandra, Trisha M Wise-Draper, Philip A Friedlander, Melissa A Burgess, Glenn J Hanna, C Lance Cowey, George Ansstas, Ciara M Kelly, Mohammed M Milhem, Cesar A Perez, Ryan M Weight, Alice S Bexon, Douglas E Laux, Theresa M Medina, Steven J O’Day, Timothy S Kristedja, Weston L Daniel, Scott Mix, Laurel Sindelar, Martin F Bexon, Robert E Michel

“…Serial tumor biopsies of injected tumors suggested upregulation of genes associated with the interferon pathway, antiviral proteins, immune checkpoints, chemokines, granzymes and costimulatory proteins, along with increases in certain immune cell populations.Conclusions Cavrotolimod had a manageable safety profile and showed clinical activity in anti-PD-(L)1 refractory cutaneous malignancies, suggesting potential for further development as an antitumor immunotherapy in combination with other agents.Trial registration number NCT03684785.…”
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How well are implementation strategies and target healthcare professional behaviors reported? A secondary analysis of 204 implementation trials using the TIDieR checklist and AACTT... by Charlene Weight, Billy Vinette, Rachael Laritz, Meagan Mooney, Sonia A. Castiglione, Marc-André Maheu-Cadotte, Nikolas Argiropoulos, Kristin Konnyu, Christine E. Cassidy, Simonne E. Collins, Sonia Semenic, Nicola Straiton, Sandy Middleton, Natalie Taylor, Marie-Pierre Gagnon, Shuang Liang, Laura Crump, Olivia Di Lalla, Talia Meyers, Daniel N. Elakpa, Guillaume Fontaine

“…Trial registration PROSPERO CRD42019130446.…”
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Unveiling biomarkers via plasma metabolome profiling for diabetic macrovascular and microvascular complications by Zhixi Li, Yuhan Ren, Feng Jiang, Kai Zhang, Xuan Meng, Yingfeng Zheng, Mingguang He

“…Abstract Background Metabolic dysregulation plays a crucial role in the development of diabetic vascular complications. Current models for diabetic vascular complications predominantly rely on three conventional parameter classes: demographic characteristics, clinical measures, and standard laboratory indices. …”
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A group psychological intervention for postnatal depression in British mothers of South Asian origin – the ROSHNI-2 RCT by Nusrat Husain, Karina Lovell, Carolyn A Chew-Graham, Farah Lunat, Penny Bee, Matthias Pierce, Najia Atif, Saadia Aseem, Kamaldeep Bhui, Peter Bower, Traolach Brugha, Nasim Chaudhry, Akbar Ullah, Linda Davies, Nadeem Gire, Deepali Sharma, Jahanara Miah, Waqas Ahmed, Joe Kai, Ilyas Mirza, Jillian Morrison, Naeem Mohmed, Atif Rahman, Shanaya Rathod, Najma Siddiqi, Waquas Waheed, Christopher Williams, Nosheen Zaidi, Richard Emsley, Richard Morriss

“…Study registration Current Controlled Trials ISRCTN10697380. …”
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Intraperitoneal irinotecan with concomitant FOLFOX and bevacizumab for patients with unresectable colorectal peritoneal metastases: protocol of the multicentre, open-label, phase I... by Jacobus W A Burger, Cornelis Verhoef, Eva V E Madsen, Robin J Lurvink, Joost Nederend, Onno Kranenburg, Geert-Jan M Creemers, Simon W Nienhuijs, Alexandra R M Brandt-Kerkhof, Esther van Meerten, Stijn L W Koolen, Ignace H J T de Hingh, Ron H J Mathijssen, Niels A D Guchelaar, Vincent C J van de Vlasakker, Teun B M van den Heuvel, Ramon J F Bax, Irene E G van Hellemond

“…The poor prognosis of unresectable CPM patients has resulted in the development of new treatment strategies where systemic therapy is combined with local, intraperitoneal chemotherapy. …”
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Breeding report of a new table Phyllanthus emblica cultivar Lütianyougan by LAI Duo, XIAO Weiqiang, QIN Jian, ZHUANG Qingli, PENG Kanghong, SHAO Xuehua

“…Currently, fresh variety of P. emblica has high economic benefit and great development potential. Herein, Lütianyougan, a new table variety of P. emblica with excellent traits, was selected from the wild seedling population. …”
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Clinical effectiveness and cost-effectiveness of the rehabilitation enablement in chronic heart failure facilitated self-care rehabilitation intervention for people with heart fail... by John G F Cleland, Kate Jolly, Christi Deaton, Louise Taylor, Rod S Taylor, Aynsley Cowie, Alex McConnachie, Julia Frost, Colin Greaves, Chim C Lang, Emma McIntosh, Valerie Smith, Samantha van Beurden, Patrick J Doherty, Hasnain M Dalal, Tracy Ibbotson, Melvyn Hillsdon, Anna Placzek, Jessica C Bollen, Iain Squire, Emma Burrell, Nick Hartshorne-Evans, Elizabeth A Thomson, Claire O’Hare, Katie Dudman, Heather Fraser, Mohammad Jarallah

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Effect of prior and first-line immunotherapy on baseline immune biomarkers and modulation of the tumor microenvironment in response to nivolumab and relatlimab combination therapy... by James Larkin, Evan J Lipson, Charlie Garnett-Benson, Ignacio Melero, Reinhard Dummer, Paolo A Ascierto, Vanna Chiarion-Sileni, Marta Nyakas, Hao Tang, Inge Marie Svane, Margaret Callahan, Eva Muñoz-Couselo, Jean Jacques Grob, Katriina Peltola, Sonia Dolfi, Carlos Alberto Gomez-Roca, Patrick Djidel, Deepti Warad, Diane Reusser-Wolf

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Protocol for a phase IV double-blind randomised controlled trial to investigate the effect of the 13-valent pneumococcal conjugate vaccine and the 23-valent pneumococcal polysaccha... by Tao Chen, Duolao Wang, Konstantinos Liatsikos, Stephen B Gordon, Hassan Burhan, Ben Morton, Tinashe K Nyazika, Bradford D Gessner, Helen Hill, Andrea Collins, Josh Hamilton, Kelly Davies, Fred Fyles, Phoebe Hazenberg, Elizabeth Begier, Angela Hyder-Wright, Sherin Pojar, Christopher Myerscough, Jesus Reine, Ryan E Robinson, Britta Urban, Elena Mitsi, Carla Solorzano, Angela Quinn, Kaijie Pan, Annaliesa S Anderson, Christian Theilacker, Daniela M Ferreira, Kelly Convey, James Court, Madlen Farrar, Lisa Hitchins, Ashleigh Howard, Lauren Kerruish, Samuel Latham, Annabel Murphy, Elissavet Nikolaou, Angelina Peterson

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FTACMT study protocol: a multicentre, double-blind, randomised, placebo-controlled trial of faecal microbiota transplantation for autism spectrum disorder by Li Ling, Wei Wei, Li Lin, Li Ke, Ye Chen, Li Ning, Wang Yu, Zhang Xin, Yang Rong, Zhang Xueying, Cui Jiaqu, Chen Qiyi, Qin Huanlong, Du Yasong, Zhao Xiaoxin, Lu Jubao, Lv Xiaoqiong, Ma Chunlian, Chen Shidong, Kuang Guifang, Zhao Dongmei, Fang Shuanfeng, Zhang Xujing, Yang Binrang, Wang Yanxia, Yuan Song, Zhou Xiang, Zhang Beihua, Jiang Lin, Ji Hong, Yan Yinmei, Yan Peihua, Huang Linsheng, Zhang Shaoyi, Ma Chenhuan, Miao Yun, Ling Wenqi, Geng Bojing, Feng Xueying, Li Huilin, Liu Liyan, Wu Weijia, Li Dexin, Jiang Qianru

“…The results of this trial will provide high-quality evidence to inform the future clinical application of this new therapy.Trial registration number ChiCTR2100043906; Pre-results.…”
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Patient-Reported Outcome Measures in Patients with Rheumatoid Arthritis, Psoriasis, or Psoriatic Arthritis Treated with GP2015, an Etanercept Biosimilar: Results from Two Phase III... by Diamant Thaçi, Sascha Gerdes, Hendrik Schulze-Koops, Yannick Allanore, Arthur Kavanaugh, Charlotte Both, Sreekanth Gattu, Sohaib Hachaichi, Marco Matucci-Cerinic

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What Are Reasons for the Large Gender Differences in the Lethality of Suicidal Acts? An Epidemiological Analysis in Four European Countries. by Roland Mergl, Nicole Koburger, Katherina Heinrichs, András Székely, Mónika Ditta Tóth, James Coyne, Sónia Quintão, Ella Arensman, Claire Coffey, Margaret Maxwell, Airi Värnik, Chantal van Audenhove, David McDaid, Marco Sarchiapone, Armin Schmidtke, Axel Genz, Ricardo Gusmão, Ulrich Hegerl

“…These findings contribute to understanding of the spectrum of reasons for gender differences in the lethality of suicidal behaviour and should inform the development of gender specific strategies for suicide prevention.…”
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Metastatic recurrence in women diagnosed with non-metastatic breast cancer: a systematic review and meta-analysis by Eileen Morgan, Colette O’Neill, Richa Shah, Oliver Langselius, Yaqi Su, Clara Frick, Hanna Fink, Aude Bardot, Paul M. Walsh, Ryan R. Woods, Lou Gonsalves, Jan F. Nygård, Serban Negoita, Esmeralda Ramirez-Pena, Karen Gelmon, Nicoleta Antone, Miriam Mutebi, Sabine Siesling, Fatima Cardoso, Julie Gralow, Isabelle Soerjomataram, Melina Arnold

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Efficacy and safety of human umbilical cord-derived mesenchymal stem cells versus placebo added to second-line therapy in patients with steroid-refractory acute graft-versus-host d... by Erlie Jiang, Kun Qian, Lu Wang, Donglin Yang, Yangliu Shao, Liangding Hu, Yuhang Li, Chen Yao, Mingzhe Han, Xiaoqiang Hou, Daihong Liu

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