Evidence that informs feeding practices in very low birthweight and very preterm infants in sub-Saharan Africa: an overview of systematic reviews by Ian Sinha, Melissa Gladstone, Janneke van de Wijgert, Kevin Mortimer, Stephen Turner, Beatrice N Ezenwa, Isa Abdulkadir, Stephen Allen, Olusegun Akinyinka, Chinyere Ezeaka, Alison Talbert, Walter Otieno, Graham Devereux, Ismaela Abubakar, Nicholas Embleton, Abimbola Akindolire, Iretiola B Fajolu, Zainab O Imam, Martha K Mwangome, Alison W Talbert, Pauline E A Andang’o, Grace M Nalwa, Helen M Nabwera, Stephen J Allen, Olukemi O Tongo, Abimbola E Akindolire, Dominic D Umoru

“…Pragmatic studies are needed to generate evidence to guide management and improve outcomes for these highly vulnerable infants.PROSPERO registration number CRD42019140204.…”
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Paternal smoking and maternal secondhand smoke exposure and the effects on the offspring: results from the EHF (Environmental Health Fund) birth cohort by Maya Berlin, Elkana Kohn, Rimona Keidar, Ayelet Livne, Ronella Marom, Amit Ovental, Dror Mandel, Ronit Lubetzky, Moshe Betser, Miki Moskovich, Ariela Hazan, Ludmila Groisman, Efrat Rorman, Matitiahu Berkovitch, Ilan Matok, Laura J. Rosen

“…Abstract Background Exposure during pregnancy to secondhand smoke (SHS) is associated with a wide range of adverse fetal development effects and perinatal outcomes. This study aimed to measure SHS exposure in pregnant women using urinary cotinine measurements and to evaluate the association between paternal smoking and maternal urine cotinine and birth outcomes in a birth cohort of Israeli mothers and children. …”
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Telephone lifestyle intervention to prevent diabetes in women with recent gestational diabetes mellitus attending the national health system: the LINDA-Brasil clinical trial by Bruce B Duncan, Maria Inês Schmidt, Paula A Bracco, Maria A Nunes, Kadhija A Cherubini, Cristina D Castilhos, Jainara Z Spagiari, Leony M Galliano, Ruben Ladwig, Fabricio B Del Vecchio, Anelita H M Del Vecchio, Michele Drehmer, Adriana Costa Forti, Cristina Façanha, Lenita Zajdenverg, Bianca de Almeida-Pititto, Rosângela Roginski Réa, Patrícia Medici Dualib

“…The COVID-19 pandemic negatively impacted trial conduction.Trial registration number NCT02327286.…”
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HEV study protocol : design of a cluster-randomised, blinded trial to assess the safety, immunogenicity and effectiveness of the hepatitis E vaccine HEV 239 (Hecolin) in women of c... by Anisur Rahman, K Zaman, Susanne Dudman, Kathrine Stene-Johansen, Firdausi Qadri, Md Yunus, Synne Sandbu, Emily S Gurley, Joakim Overbo, Cathinka Halle Julin, Jennifer Lynn Dembinski, Quamrun Nahar, Taufiqur R Bhuiyan, Mustafizur Rahman, Warda Haque, Jahangir Khan, Asma Aziz, Mahbuba Khanam, Peter Kim Streatfield, John D Clemens

“…Introduction Hepatitis E virus (HEV) is a leading cause of acute viral hepatitis in the developing world and is a public health problem, in particular among pregnant women, where it may lead to severe or fatal complications. …”
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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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Optimizing treatment for depression in primary care using psychotherapy versus antidepressant medication in a low-resource setting: protocol for the OptimizeD randomized controlled... by Julia R. Pozuelo, Anuja Lahiri, Rahul S. P. Singh, Arvind Kushwah, Mimansa Khanduri, Akanksha Shukla, Azaz Khan, Sruthi G., Varun Shende, Yashika Parashar, Yashwant K. Mehra, Anant Bhan, Ronald C. Kessler, Daisy R. Singla, John A. Naslund, Karmel W. Choi, Pim Cuijpers, Robert DeRubeis, Mohammad M. Herzallah, Chunling Lu, Jordan W. Smoller, Tyler J. VanderWeele, Abhijit R. Rozatkar, Tamonud Modak, Michelle Melwyn Joel, Debasis Biswas, Shubham Atal, Umay Kulsum, Steven D. Hollon, Vikram Patel

“…Using machine learning, we will attempt to develop a precision treatment rule that leverages baseline clinical, psychological, cognitive, socioeconomic, and biological data to predict which treatment is most likely to achieve remission for each patient. …”
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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

“…Conclusions This multicenter study identified the distinct realities of post-sepsis life in Japanese ICU patients, highlighting the unique challenges in improving their functions and returning to daily life. Trial Registration University Hospital Medical Information Network UMIN000041433…”
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Clinical predictors of flare and drug-free remission in rheumatoid arthritis: preliminary results from the prospective BIO-FLARE experimental medicine study by Iain B McInnes, Stefan Siebert, Arthur Pratt, Andrew Filer, Karim Raza, Wan-Fai Ng, Christopher D Buckley, Dawn Teare, Andrew Melville, Amy Anderson, Andrew McGucken, Bernard Dyke, Catharien M U Hilkens, John Isaacs, Kenneth F Baker, Mohadeseh Shojaei Shahrokhabadi, Shaun Hiu, Theophile Bigirumurame, Carl Goodyear, Fiona Rayner, Sean Kerrigan, Jonathan Prichard

“…The BIO-FLARE study design provides a robust experimental medicine model for studying flare and remission immunobiology.Trial registration number ISRCTN registry 16371380…”
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Study design and procedures for a hybrid effectiveness-implementation incomplete stepped-wedge cluster-randomized trial to evaluate a differentiated point-of-care HIV diagnosis and... by Michael E. Herce, Caitlin Cassidy, Alexandra Munson, Jessie K. Edwards, Sarah E. Rutstein, Mitch Matoga, Chimwemwe Kumwenda, Katherine R. Simon, Joep J. van Oosterhout, Carrie M. Cox, Funny Kamanga, Wiza Kumwenda, Sam Phiri, Ethel Rambiki, Agness Thawani, Jacqueline Huwa, Bridget Malewezi, Tisu Mvalo, Agatha Bula, Lameck Chinula, Irving Hoffman, Madeleine A. Squibb, Rose K. Nyirenda, Friday Saidi, Mina C. Hosseinipour, Maganizo B. Chagomerana

“…To reach PBFW living with HIV and their infants who miss critical HIV services and who are at higher risk for adverse HIV outcomes, including vertical transmission, we developed the “Point-of-care Active Case finding & Management” or “PAC-Man” model. …”
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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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Exploring the acceptability, appropriateness, feasibility and satisfaction of an implementation strategy for out-of-HOspital administration of the Long-Acting combination of cabote... by Jordi Puig, Vicenç Falcó, Cristina Miranda, Francis Ruiz, Julián Olalla, Àngel Rivero, Patricia Álvarez-Lopez, Eugenia Negredo, Diana Hernández-Sánchez, Javier Jusmet, Miguel Ángel Cuerda Palomo, Ana Belén Flores de la Cruz, José Manuel Pavón, Nadia Llavero, David Campany, Vicente Faus, Claudia Broto-Cortés, Lucía Bailón, Dámaris Aguilar, David Rovira

“…If the outcome is deemed positive, we will also develop and propose policy guidelines for the integration of the administration of CAB+RPV LA in alternative outpatient facilities into the standard of care in the HIV care pathway.Trial registration number NCT06185452/EUCT number: 2023-503963-41-00.…”
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Evaluating an intervention to promote access to mental healthcare for low language proficient migrants and refugees across Europe (MentalHealth4All): study protocol for a pretest–p... by Fang Wang, Mike Mösko, Demi Krystallidou, Yuhui Chen, Liza G G van Lent, Saskia Hanft-Robert, Ilaria Galasso, Barbara Schouten, Antoon Cox, Sona Hodakova, Chiara Rao, Koen Kerremans, Raquel Lázaro Gutiérrez, Özlem Temizöz, Dalia Mankauskienė, Łucja Biel, Emilio Di Maria, Julia van Weert, Melanie de Looper, Gian Hernandez, Gaukhar Orkashbayeva, Tobias Kleineidam, Angeliki Tsoukaneli, Mehmet Uygun, Ily Hollebeke, Beatrice Bünsch, Leon Köchel, Mia Mengtong Li, Mara Morelli, Stefania Muzi, Cecilia Serena Pace, Carlotta Gualco, Nijolė Maskaliūnienė, Katarzyna Czarnocka-Gołębiewska, Urszula Okulska-Łukawska, Argnieszka Biernacka, Aleksandra Kalata-Zawłocka, Agnieszka Słopień, Natalia Pytlińska, Monika Šavelová, Andrej Birčák, Daniela Müglová, Carmen Valero Garcés, Carmen Pena Díaz, Elena Alcalde Peñalver, Cristina Álvaro Aranda, Silvia Damianova Radeva, Sabine Braun, Jaleh Delfani, Graham Hieke, Elena Davitti, Constantin Orasan, Lieven Buysse

“…As part of the MentalHealth4All project, a digital multilingual communication and information platform was developed to promote access to mental healthcare for LLP migrants and refugees across Europe. …”
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Shortening duration of untreated illness in young people with first episode eating disorders: protocol of a randomised controlled feasibility trial of a smartphone friendly multi-m... by Luiza Grycuk, Dina Monssen, Molly R. Davies, Helen Sharpe, Karina L. Allen, Vibhore Prasad, Rachel Potterton, Priya Popat, Victoria A. Mountford, Sheryllin McNeil, Vanessa Lawrence, Nina Grant, Kimberley A. Goldsmith, Danielle Glennon, Sarah Byford, Amy Brown, Ulrike Schmidt

“…An important focus of early intervention is shortening the time between a person first developing symptoms and starting treatment (duration of untreated eating disorder; DUED). …”
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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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Clinical course, causes of worsening, and outcomes of severe ischemic stroke: A prospective multicenter cohort study by Simiao Wu, Yanan Wang, Ruozhen Yuan, Meng Liu, Xing Hua, Linrui Huang, Fuqiang Guo, Dongdong Yang, Zuoxiao Li, Bihua Wu, Chun Wang, Jingfeng Duan, Tianjin Ling, Hao Zhang, Shihong Zhang, Bo Wu, Cairong Zhu, Craig S. Anderson, Ming Liu, Ting Gao

“…Reperfusion reduced the risk of clinical worsening and improved functional outcomes. Registration:. ClinicalTrials.gov, NCT03222024.…”
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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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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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