Randomised controlled trial to evaluate the effectiveness of using the RD-1-based C-Tb skin test as a replacement for blood-based interferon-γ release assay for detection of, and i... by Marc Lipman, Ibrahim Abubakar, Chris Griffiths, Penny Whiting, Robert Horne, Alex Ghanouni, Heinke Kunst, Mike Mandelbaum, Molebogeng X Rangaka, Karen Sanders, Peter J White, Angela Crook, Dominik Zenner, Trinh Duong, Vanessa Hack, Julian Surey, Yohhei Hamada, Henry Bern, Joanna Calvert, Marie Francis, Amy Louise Clarke, Ellen Owen-Powell, Helen L Booth

“…Economic analysis will estimate cost-effectiveness of changes to the diagnostic algorithm for LTBI. The protocol was developed with Patient and Public Involvement (PPI), which will continue throughout the trial.Ethics and dissemination Ethics approval has been obtained from The NHS Health Research Authority (269485). …”
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Association of humidity and precipitation with asthma: a systematic review and meta-analysis by Wangyang Gu, Wangyang Gu, Dan Xie, Dan Xie, Qinpeng Li, Qinpeng Li, Huike Feng, Huike Feng, Yihao Xue, Yihao Xue, Yang Chen, Jingyi Tang, Yushi Zhou, Yushi Zhou, Dan Wang, Dan Wang, Shilu Tong, Shilu Tong, Shijian Liu, Shijian Liu, Shijian Liu, Shijian Liu

“…And the influence of precipitation on asthma persons over the age of 18, developing countries or regions, and middle latitudes significantly. …”
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Strategic multimodal intervention in at-risk elderly Indians for prevention of dementia (SMRUTHI INDIA): a cohort multiple randomised controlled trial (cmRCT) protocol by Pooja Sharma, Divyani Garg, Maroof Ahmad Khan, Ayush Agarwal, Manish Barvaliya, Shubham Gupta, Alex Rebello, Ashima Nehra, Anu Gupta, Padma Srivastava, Kritika Sharma, Subrata Baidya, Abhik Sinha, Shampa Das, Sunil Kumar Raina, Sakshi Sharma, Venugopalan Y Vishnu, Varuna Sharma, Subarna Roy, P K Anand, Nilima Nilima, Vaibhav Patil, Rajeev Aggarwal, Aditi Dubey, Hina Narzari, Sneha Sneha, Kamini Kashyap, Krishan Kaushal, Kajal Fulara, Shikha Chaudhary, Divya M R, Vasundhara Misra, Phaniraj Vastrad, Priyadarshanraj N, Sandesh J R, Harshath Ajay V, Aishwarya Bhovi, Mailrappa Padiyappa Hooli, Sagar P M, Ambika Y V, Ripanjit Singh, Naveen M R, Shilpa K, Sharanabasavaraj Devaramani, Sandip Bhattacharjee, Bishakha Sen, Shalina Jamatia, Manish Acharjee, Dipankar Deb, Pameli Jamatia, Munmun Debbarma, Shaily Bhushan, Rishabh Gautam, Rishav Bhatia, Arnav Verma, Kalpna Sharma, Gajraj Singh, Priyanka Kumari Meena, Akhilesh Nagar, Hitesh Tiwari, Tinku Yogi, Vikram Raigar, Vinny Wilson, Shradha Singh, Zubia Nasir, Daksha Kumari, Mallamma Duddagi, Basamma R Alur, Sreetama Bahaduri, Aditya Choudhary, Suhas Murali, Jyoti Kattna, Amita Sengupta, Dolan Roy, Tithi Patra, Bandana Kayestha, Yachana Sharma, Nandini Rawat, Kavita Bairwa, Muskan Sharma, Divyani Rathore

“…The ‘Strategic Multimodal Intervention in at-risk Elderly Indians for Prevention of Dementia (SMRUTHI INDIA)’ study will be conducted to establish a trial-ready cohort of elderly Indians who are at high risk of developing dementia.Methods and analysis The main aim of the study is to create and study a cohort of individuals at high risk of dementia in rural India, where we can do multiple intervention trials. …”
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Association Between Maternal Undernutrition and Pre‐Labor Rupture of Membranes in Ethiopia: A Systematic Review and Meta‐Analysis of Observational Studies by Ebrahim Msaye Assefa, Hussen Abdu, Altaseb Beyene Kassaw, Mekonnen Belete, Amare Abera Tareke, Addis Alem, Mohammed Derso Bihonegn, Abdulaziz Kebede Kassaw, Ahmed Juhar Temam, Gashaw Abebe, Melese Shenkut Abebe, Gosa Mankelkl, Zeleke Geto, Seid Mohammed Abdu

“…Policymakers need to develop public health policies to address maternal nutrition. …”
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Testing a systematically braided alcohol reduction and HIV status neutral intervention among people receiving STI care in Malawi: study protocol for a pilot hybrid type 1 effective... by Kathryn E. Lancaster, Agatha K. Bula, Mitch M. Matoga, Mina C. Hosseinipour, Mina C. Hosseinipour, Irving F. Hoffman, Irving F. Hoffman, Jaslyn A. Grullon, Eric Umar, Jimmy Msolola, Jessica F. Magidson, Jessica L. Bonumwezi, Judith A. Hahn, Angela M. Parcesepe

“…BackgroundHeavy alcohol use is common in Malawi among people receiving sexually transmitted infections (STI) care and is a critical barrier to the success of HIV prevention and treatment efforts.MethodsThis protocol presents a pilot hybrid type 1 effectiveness-implementation trial evaluating the short-term effectiveness and implementation of a scalable evidence-based intervention (EBI) to reduce alcohol use and provide HIV prevention and treatment counseling for people with heavy drinking receiving STI care in Malawi. We developed a 3-session intervention, Treat4All, that uses motivational interviewing, problem-solving skills, psychoeducation, alcohol refusal, HIV prevention and treatment skills building, and goal setting to reduce alcohol and facilitate engagement in HIV prevention and treatment. …”
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Risk factors and prediction model of breast cancer-related lymphoedema in a Chinese cancer centre: a prospective cohort study protocol by Yue Wang, Xin Li, Ying Wang, Hongmei Zhao, Qian Lu, Yujie Zhou, Liyuan Zhang, Aomei Shen, Jingru Bian, Wanmin Qiang, Jingming Ye, Hongmeng Zhao, Yubei Huang, Zhongning Zhang, Peipei Wu

“…The results of this study will be published in peer-reviewed journals and will be presented at several research conferences.Trial registration number ChiCTR2200057083.…”
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Addressing uncertainty in identifying pregnancies in the English CPRD GOLD Pregnancy Register: a methodological study using a worked example by Yangmei Li, Jennifer J Kurinczuk, Fiona Alderdice, Maria A Quigley, Oliver Rivero-Arias, Julia Sanders, Sara Kenyon, Dimitrios Siassakos, Nikesh Parekh, Suresha De Almeida, Claire Carson

“…We developed a cleaning and combining algorithm and further applied strict data quality criteria to form three populations: 'as provided', 'derived' (using our algorithm) and 'strictly derived' (with stricter data quality criteria). …”
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Early Recognition and Intervention in SIBlingS at High Risk for Neurodevelopment Disorders (ERI-SIBS): a controlled trial of an innovative and ecological intervention for siblings... by Silvia Annunziata, Giulia Purpura, Giulia Purpura, Elena Piazza, Paolo Meriggi, Gabriele Fassina, Laura Santos, Emilia Ambrosini, Antonella Marchetti, Antonella Marchetti, Federico Manzi, Federico Manzi, Davide Massaro, Davide Massaro, Andrea Luna Tacci, Andrea Luna Tacci, Elisabetta Bolognesi, Simone Agostini, Francesca La Rosa, Alessandra Paola Giulia Pedrocchi, Paola Molina, Anna Cavallini

“…BackgroundIt has been widely demonstrated that siblings of children with autism spectrum disorder (ASD) have an increased risk of abnormal developmental trajectories. In response to this, early recognition protocols have been developed worldwide, aiming to promote early interventions that can positively impact the neurodevelopment of this population. …”
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Protocol and research program of the European registry and biobank for interstitial lung diseases (eurILDreg) by Ekaterina Krauss, Silke Tello, Jennifer Naumann, Sandra Wobisch, Clemens Ruppert, Stefan Kuhn, Poornima Mahavadi, Raphael W. Majeed, Philippe Bonniaud, Maria Molina-Molina, Athol Wells, Nik Hirani, Carlo Vancheri, Simon Walsh, Matthias Griese, Bruno Crestani, Andreas Guenther, on behalf of further eurILDreg investigators, RARE-ILD investigators

“…Methods The foundation of eurILDreg is built on a comprehensive parameter list developed and adopted by clinical experts, encompassing over 1,800 distinct parameters related to patient history, clinical examinations, diagnosis, lung function and biospecimen collection. …”
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Endothelial Function Assessed by Automatic Measurement of Enclosed Zone Flow‐Mediated Vasodilation Using an Oscillometric Method Is an Independent Predictor of Cardiovascular Event... by Haruka Morimoto, Masato Kajikawa, Nozomu Oda, Naomi Idei, Harutoyo Hirano, Eisuke Hida, Tatsuya Maruhashi, Yumiko Iwamoto, Shinji Kishimoto, Shogo Matsui, Yoshiki Aibara, Takayuki Hidaka, Yasuki Kihara, Kazuaki Chayama, Chikara Goto, Kensuke Noma, Ayumu Nakashima, Teiji Ukawa, Toshio Tsuji, Yukihito Higashi

“…Background A new device for automatic measurement of flow‐mediated vasodilation (FMD) using an oscillometric method has been developed to solve technical problems of conventional FMD measurement. …”
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A phase I/II trial evaluating the safety of increased-dose S- 1 with oxaliplatin and nivolumab in HER2-negative advanced gastric cancer by Keisuke Baba, Nobumi Suzuki, Chiyo K. Imamura, Eisuke Booka, Masashi Takeuchi, Daisuke Takahari, Takeshi Kawakami, Hirofumi Kawakubo, Chiyoe Kitagawa, Yoshiyasu Kono, Keiji Ogura, Yosuke Kito, Kei Saito, Shinzo Yamamoto, Hiroya Takeuchi, Toshihiro Kudo, Takuya Tsunoda, Takuro Mizukami, Toshifumi Yamaguchi, Hirokazu Shoji, Kanako Saito, Kenro Tanoue, Eishi Baba, Kengo Nagashima, Narikazu Boku

“…Abstract Background We developed and refined an S-1 dosage formula based on renal function, sex, and body surface area (BSA) to achieve the target area under the concentration–time curve of 5-fluorouracil in two prospective pharmacokinetic studies. …”
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My Back Exercise app: an automated exercise intervention supported by educational notifications, a sleep programme and diet advice to improve function in people with chronic non-sp... by Manuela L Ferreira, Kim L Bennell, Christopher J Gordon, Josielli Comachio, Paulo Ferreira, Rachel K Nelligan, Serigne N Lo, Paula Beckenkamp, Anelise Moreti Cabral Silveira, Carlos Mesa-Castrillon, Katharine Roberts, Emma K Ho, Rowena J Field

“…In this context, the My Back Exercise app has been developed to support people with LBP in self-managing their condition. …”
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At-home Breast Oncology care Delivered with EHealth solutions (ABODE) study protocol: a randomised controlled trial by Wei Xu, Eitan Amir, Madeline Li, Gary Rodin, Toni Zhong, Raymond H Kim, Allan Okrainec, Michael Reedijk, David McCready, Emily Thain, Kelly Metcalfe, Siba Haykal, Jeanna Mccuaig, Robin Forbes, Jaime Escallon, Janet Papadakos, Erin Kennedy, Amanda Mac, Dalia Schaffer, Mohini Kalia, Emma Reel, Adina Isenberg, C Anne Koch, Sarah Rotstein, Tulin D Cil, Jordan Cleland, Alexandra Easson, Sheila Jarvis, Wey Leong, Daniel Santa Mina, Larissa Peck, Sharmy Sarvanantham, Fahreen Walimohamed

“…Introduction The COVID-19 pandemic disrupted healthcare delivery for patients with breast cancer. eHealth solutions enable remote care and may improve patient activation, which is defined as having the knowledge, skills and confidence to manage one’s health. Thus, we developed the Breast Cancer Treatment Application (app) for patients and practitioners to use throughout the cancer care continuum. …”
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Randomized phase II study of the Bruton tyrosine kinase inhibitor acalabrutinib, alone or with pembrolizumab in patients with advanced pancreatic cancer by Al B Benson, Anirban Maitra, Milind Javle, Michael Overman, Richard E Davis, Pankaj Vats, Chandan Kumar-Sinha, Lianchun Xiao, Niharika B Mettu, Edwin R Parra, Charles D Lopez, Veerendra Munugalavadla, Priti Patel, Lin Tao, Sattva Neelapu

“…Efforts to understand and target the pancreatic tumor microenvironment should continue.Trial registration number NCT02362048.…”
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Clinical phenotyping of people living with type 1 diabetes according to their levels of diabetes-related distress: results from the SFDT1 cohort by Guy Fagherazzi, Louis Potier, Fawaz Alzaid, Jean-Pierre Riveline, Fabrice Bonnet, Bruno Verges, Sandrine Lablanche, Pierre Yves Benhamou, Eric Renard, Samy Hadjadj, Emmanuel Cosson, Gloria Aguayo, Dulce Canha, Patricia Vaduva, Helene Hanaire, Yves Reznik

“…Our results underscore the importance of developing DD-targeted prevention and intervention strategies focused specifically on high-risk groups and the most impactful distress subdimensions to reduce the impact of type 1 diabetes burden.Trial registration number NCT04657783.…”
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Telehealth-delivered cognitive rehabilitation for people with cognitive impairment as part of the post-COVID syndrome: protocol for a randomised controlled trial as part of the CIC... by Martina Vanova, Aysha Mohamed Rafik Patel, Iona Scott, Gina Gilpin, Emily N. Manning, Charlotte Ash, Philippa Wittenberg, Jason Lim, Zoe Hoare, Rachel Evans, Nathan Bray, Christopher M. Kipps, Ciara Devine, Saliha Ahmed, Ross Dunne, Anna Koniotes, Catherine Warren, Dennis Chan, Aida Suarez-Gonzalez

“…Despite this significant morbidity, there is a paucity of interventions for this disorder that have undergone evaluation within a formal trial setting. Therefore, we have developed a cognitive rehabilitation programme, specifically designed to address the cognitive symptoms of PASC, notably impaired attention and processing speed, while also accounting for other PASC symptoms (fatigue, post-exertional malaise) that may aggravate the cognitive impairment. …”
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Somatostatin analogue continuation upon progression in patients with gastroenteropancreatic neuroendocrine tumour (SAUNA trial): a randomised controlled trial protocol by Suzanne Polinder, Ivan Borbath, Marc Peeters, Philippe Beutels, Elke Smits, Iris Verhaegen, Ella Roelant, Wouter Dercksen, Stella Heemskerk, Siddharth Chhajlani, Jelka Kuiper, Christophe M Deroose, Isolde Van der Massen, Annemiek Walenkamp, Wouter W de Herder, Johannes Hofland, Timon Vandamme

“…The study design was developed in cooperation with the Belgium and Dutch patient organisations.Ethics and dissemination The study has been approved on 31 May 2023 by the Ethical Committees and Regulatory Authorities of the concerned member states (EU CT number 2022-502703-30-00). …”
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“HEAL together”: a randomized, hybrid type 1 effectiveness-implementation trial protocol of a peer-delivered behavioral activation intervention to improve methadone treatment reten... by Jessica F. Magidson, Jessica F. Magidson, Valerie D. Bradley, Jessica S. Anane, Mary B. Kleinman, Julia W. Felton, Abigail C. Hines, Rithika Baskar, Aaron D. Greenblatt, Dwayne Dean, Morgan S. Anvari, Heather Fitzsimons, Melanie E. Bennett, Annabelle M. Belcher

“…Peer recovery specialists (PRSs) may play an important role in OUD treatment retention, yet few evidence-based interventions to support OUD retention have been developed specifically for PRS delivery. Behavioral activation is a brief, reinforcement-based intervention with empirical support for improving depression and substance use outcomes, delivered typically by specialist mental health providers. …”
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Identifying the needs of natural caregivers caring for a person with dementia: a mixed method study by Clarisse Dibao-Dina, Lydia Nasri, Céline Dagot, Jean-Philippe Fouquet, Sophie Rideau, Vincent Dumas, Guillaume Neff, Véronique Payen, Delphine Rube-Millon, Marie Lemaile, Jacques-Alexis Nkodo, Vincent Camus, Bertrand Fougère, Bruno Giraudeau, Dominique Beauchamp, Laura Fruchard-Foucault, Cécile Renoux, Jean Robert

“…This study aims to evaluate caregivers’ needs with the future goal of developing a tailored, multicomponent intervention to ease caregiver challenges through appropriate caregiver-centred interventions. …”
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Diagnostic accuracy of case-identification algorithms for heart failure in the general population using routinely collected health data: a systematic review by Anita Andreano, Vito Lepore, Pietro Magnoni, Alberto Milanese, Caterina Fanizza, Deborah Testa, Alessandro Musa, Adele Zanfino, Paola Rebora, Lucia Bisceglia, Antonio Giampiero Russo, the PROPHET-I study group

“…Several algorithms based on administrative health data (HAD) have been developed to detect patients with HF in a timely and inexpensive manner, in order to perform real-world studies at the population level. …”
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