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  1. Clinical trials often involve some form of interim monitoring to determine futility before planned trial completion. While many options for interim monitoring exist (e.g., alpha-spending, conditional power), n...

    Authors: Jessica L. Wild, Adit A. Ginde, Christopher J. Lindsell and Alexander M. Kaizer
    Citation: Trials 2024 25:312
  2. HIV-associated tuberculosis (TB) contributes disproportionately to global tuberculosis mortality. Patients hospitalised at the time of the diagnosis of HIV-associated disseminated TB are typically severely ill...

    Authors: Phiona E. Namale, Linda Boloko, Marcia Vermeulen, Kate A. Haigh, Fortuna Bagula, Alexis Maseko, Bianca Sossen, Scott Lee-Jones, Yoliswa Msomi, Helen McIlleron, Ayanda Trevor Mnguni, Thomas Crede, Patryk Szymanski, Jonathan Naude, Sakeena Ebrahim, Yakoob Vallie…
    Citation: Trials 2024 25:311
  3. Use of electronic methods to support informed consent (‘eConsent’) is increasingly popular in clinical research. This commentary reports the approach taken to implement electronic consent methods and subsequen...

    Authors: William J Cragg, Chris Taylor, Lauren Moreau, Howard Collier, Rachael Gilberts, Niamh McKigney, Joanna Dennett, Sandra Graca, Ian Wheeler, Liam Bishop, Adam Barrett, Suzanne Hartley, John P Greenwood, Peter P Swoboda and Amanda J Farrin
    Citation: Trials 2024 25:310
  4. Inflamm-aging is associated with the rate of aging and is significantly related to diseases such as Alzheimer’s disease, Parkinson’s disease, atherosclerosis, heart disease, and age-related degenerative diseas...

    Authors: Ngoc-Huynh Ton Nguyen, Hao Thanh Phan, Phong Minh Le, Lan-Huong Thi Nguyen, Thuy Thi Do, Thien-Phuc Thanh Phan, Trinh Van Le, Thanh Minh Dang, Chinh-Nhan Lu Phan, Tung-Loan Thi Dang and Nhung Hai Truong
    Citation: Trials 2024 25:309
  5. Acute respiratory distress syndrome (ARDS) is a frequent cause of hypoxemic respiratory failure with a mortality rate of approximately 30%. Identifying ARDS subphenotypes based on “focal” or “non-focal” lung m...

    Authors: Jante S. Sinnige, Marry R. Smit, Aniruddha Ghose, Harm-Jan de Grooth, Theis Skovsgaard Itenov, Eleni Ischaki, John Laffey, Frederique Paulus, Pedro Póvoa, Charalampos Pierrakos, Luigi Pisani, Oriol Roca, Marcus J. Schultz, Konstanty Szuldrzynski, Pieter R. Tuinman, Claudio Zimatore…
    Citation: Trials 2024 25:308
  6. Aging has been associated with a progressive loss of skeletal muscle quality, quantity and strength, which may result in a condition known as sarcopenia, leading to a decline in physical performance, loss of i...

    Authors: David J. Barry, Joshua B. Farragher, Andrew C. Betik, Jackson J. Fyfe, Lilia Convit and Matthew B. Cooke
    Citation: Trials 2024 25:307
  7. Premature infants commonly encounter difficulties with oral feeding, a complication that extends hospital stays, affects infants’ quality of life, and imposes substantial burdens on families and society. Enhan...

    Authors: Yingxin Li, Yanlin Hu, Yuan Li, Xia Li, Xi Huang, Zeyao Shi, Ru Yang, Xiujuan Zhang and Qiong Chen
    Citation: Trials 2024 25:306
  8. To analyze the perioperative bleeding and hidden blood loss (HBL) of sacroiliac screw minimally invasive treatment of pelvic posterior ring injury and explore the influential factors of HBL after operation for...

    Authors: Ding Xu, Min Liu, Weigang Lou, Ming Li, Jingwei Xiao, Hongbao Wu, Yunqiang Zhuang and Jianming Chen
    Citation: Trials 2024 25:305
  9. Demographic changes, with an increasing number and proportion of older people with multimorbidity and frailty, will put more pressure on home care services in municipalities. Frail multimorbid people receiving...

    Authors: Anette Væringstad, Ellen Thea Gjelseth Dalbak, Daniela Holle, Janne Myhre, Øyvind Kirkevold, Sverre Bergh and Bjørn Lichtwarck
    Citation: Trials 2024 25:304
  10. With roughly 45,000 adult patients each year, distal radius fractures are one of the most common fractures in the emergency department. Approximately 60% of all these fractures are displaced and require surger...

    Authors: B. M. Derksen, P. A. Jawahier, O. Wijers, S. P. Knops, M. R. de Vries, C. C. Drijfhout van Hooff, M. H. J. Verhofstad and N. W. L. Schep
    Citation: Trials 2024 25:303
  11. The Brief Educational Workshops in Secondary Schools Trial (BESST) is an England-wide school-based cluster randomised controlled trial assessing the clinical and cost-effectiveness of an open-access psychologi...

    Authors: Kirsty James, Stephen Lisk, Chloe Payne-Cook, Zamena Farishta, Maria Farrelly, Ayesha Sheikh, Monika Slusarczyk, Sarah Byford, Crispin Day, Jessica Deighton, Claire Evans, Peter Fonagy, David Saunders, Irene Sclare, James Shearer, Paul Stallard…
    Citation: Trials 2024 25:302
  12. Maintenance therapy with niraparib, a poly(ADP-ribose) polymerase inhibitor, has been shown to extend progression-free survival in patients with newly diagnosed advanced ovarian cancer who responded to first-l...

    Authors: Jimmy Belotte, Brunella Felicetti, Amanda J. Baines, Ahmed YoussefAgha, Luis Rojas-Espaillat, Ana Godoy Ortiz, Diane Provencher, Raúl Márquez Vázquez, Lucia González Cortijo and Xing Zeng
    Citation: Trials 2024 25:301
  13. Minimally invasive glaucoma surgery (MIGS) is a new class of surgeries, which combines moderate to high success rates and a high safety profile. Bent Ab interno Needle Goniotomy (BANG) and Gonioscopy-Assisted ...

    Authors: Gabriel Ayub, Ticiana De Francesco and Vital Paulino Costa
    Citation: Trials 2024 25:300
  14. The use of antibiotics is a key driver of antimicrobial resistance and is considered a major threat to global health. In Denmark, approximately 75% of antibiotic prescriptions are issued in general practice, w...

    Authors: Julie Jepsen Strøm, Camilla Aakjær Andersen, Martin Bach Jensen, Janus Laust Thomsen, Christian B. Laursen, Søren Helbo Skaarup, Hans Henrik Lawaetz Schultz and Malene Plejdrup Hansen
    Citation: Trials 2024 25:298
  15. Authors: Simron Singh, Diego Ferone, Jaume Capdevila, Jennifer Ang Chan, Wouter W. de Herder, Daniel Halperin, Josh Mailman, Lisa Hellström, Hanna Liedman, Agneta Svedberg and Fredrik Tiberg
    Citation: Trials 2024 25:297

    The original article was published in Trials 2024 25:58

  16. The optimal amount and timing of protein intake in critically ill patients are unknown. REPLENISH (Replacing Protein via Enteral Nutrition in a Stepwise Approach in Critically Ill Patients) trial evaluates whe...

    Authors: Yaseen M Arabi, Hasan M. Al-Dorzi, Omar Aldibaasi, Musharaf Sadat, Jesna Jose, Dina Muharib, Haifa Algethamy, Abdulrahman A. Al-Fares, Fahad Al-Hameed, Ahmed Mady, Ayman Kharaba, Ali Al Bshabshe, Khalid Maghrabi, Khalid AlGhamdi, Ghulam Rasool, Adnan AlGhamdi…
    Citation: Trials 2024 25:296
  17. Despite several incremental improvements in the management of tuberculous meningitis (TBM), the mortality rates remain high. In spite of national and international guidelines, variation in the choice, dose, an...

    Authors: Leeberk Raja Inbaraj, Abi Manesh, C. Ponnuraja, Adhin Bhaskar, Vignes Anand Srinivasalu and Bella Devaleenal Daniel
    Citation: Trials 2024 25:294
  18. Distressing symptoms are common in advanced cancer. Medicinal cannabinoids are commonly prescribed for a variety of symptoms. There is little evidence to support their use for most indications in palliative ca...

    Authors: Taylan Gurgenci, Janet Hardy, Georgie Huggett, Karyn Foster, Anita Pelecanos, Ristan Greer, Jennifer Philip, Alison Haywood, Ruwani Mendis, Patsy Yates and Phillip Good
    Citation: Trials 2024 25:293
  19. Providing informed consent for trials requires providing trial participants with comprehensive information about the trial, including information about potential risks and benefits. It is required by the ethi...

    Authors: Laura Cuddihy, Jeremy Howick, Ellen Murphy and Frances Shiely
    Citation: Trials 2024 25:292
  20. Antenatal balanced energy and protein (BEP) supplements have well-documented benefits for pregnancy outcomes. However, considerable practical gaps remain in the effective and cost-effective delivery of antenat...

    Authors: Dongqing Wang, Tigest Shifraw, Janaina Calu Costa, Semira Abdelmenan, Sitota Tsegaye, Yoseph Berhane, Hanna Gulema, Hanna Berhane, Nebiyou Fasil, Firehiwot Workneh, Workagegnhu Tarekegn, Molin Wang, Nicolas A. Menzies, Alemayehu Worku, Yemane Berhane and Wafaie W. Fawzi
    Citation: Trials 2024 25:291
  21. This paper describes the protocols for a randomized controlled trial using a parallel-group trial design that includes an intervention designed to address social isolation and loneliness among people experienc...

    Authors: Benjamin F. Henwood, Bo-Kyung Elizabeth Kim, Amy Stein, Gisele Corletto, Himal Suthar, Kevin F. Adler, Madeline Mazzocchi, Julia Ip and Deborah K. Padgett
    Citation: Trials 2024 25:290
  22. Iron and folic acid (IFA) supplements are currently provided to Cambodian women during pregnancy. However, recent research has found benefits of a multiple micronutrient supplement (MMS) over just IFA alone on...

    Authors: Mai-Anh Hoang, Hou Kroeun, Rolf Klemm, Aman Sen Gupta, Ngik Rem, Sokchea Meng, Sophonneary Prak, Kim Rattana, Mary Chea, Crystal D. Karakochuk, Cassandra Sauer, Ashutosh Mishra, Diwakar Mohan and Meredith Jackson de-Graffenried
    Citation: Trials 2024 25:289
  23. Acute kidney injury (AKI) is a significant postoperative complication associated with increased mortality and hospital costs. Hemodynamic strategies, such as goal-directed therapy, might reduce AKI risk. Predi...

    Authors: Javier Ripollés-Melchor, Laura Carrasco-Sánchez, José L. Tomé-Roca, César Aldecoa, Andres Zorrilla-Vaca, Juan V. Lorente-Olazábal, María J. Colomina, Ana Pérez, Juan I. Jiménez-López, Rosalía Navarro-Pérez, Alfredo Abad-Gurumeta and Manuel I. Monge-García
    Citation: Trials 2024 25:288
  24. Neovascular glaucoma (NVG) is an irreversible blinding eye disease worldwide and is classified as one of the refractory glaucoma conditions, severely impacting visual function and vision. Unfortunately, effect...

    Authors: Shuqing Zhu, Mengtian Zhou, Haoyu Li, Shaodan Zhang, Shuxia Xu, Haishuang Lin, Yanqie Xie, Rongrong Le and Yuanbo Liang
    Citation: Trials 2024 25:287
  25. The fragility index is a statistical measure of the robustness or “stability” of a statistically significant result. It has been adapted to assess the robustness of statistically significant outcomes from rand...

    Authors: Leen Naji, Brittany Dennis, Myanca Rodrigues, Monica Bawor, Alannah Hillmer, Caroul Chawar, Eve Deck, Andrew Worster, James Paul, Lehana Thabane and Zainab Samaan
    Citation: Trials 2024 25:286
  26. Urinary incontinence is highly prevalent in women while pelvic floor muscle training is recommended as the first-line therapy. However, the exact treatment regimen is poorly understood. Also, patients with pel...

    Authors: Chunmei Chen, Jing Zhang, Hong Zhang, Haiyan Li, Jucheng Yu, Yao Pei and Yuan Fang
    Citation: Trials 2024 25:285
  27. The incidence of hemiparetic limb dysfunction reaches 85% in stroke patients, emerging as a critical factor influencing their daily lives. However, the effectiveness of current rehabilitation treatments is con...

    Authors: Wang Fu, Xiaoming Yu, Minghui Lai, Yuanli Li, Yingting Yang, Yong Qin, Min Yu, Feng Wang and Cong Wang
    Citation: Trials 2024 25:284
  28. Colorectal cancer (CRC) is the second most lethal cancer in the United States (U.S.) with the highest incidence and mortality rates among African Americans (AAs) compared to other racial groups. Despite these ...

    Authors: Olajide Williams, Tina Ting, Lisa Matthews, Gladys Block, Torin Block, Jeanne Teresi, Joseph Eimicke, Jian Kong, Stephanie Silver, Joseph Ravenell, Janhavi Mallaiah, Soujanya Jammalamadaka, Laura Maudene Nelson, Wahida Karmally and Sidney Hankerson
    Citation: Trials 2024 25:283
  29. In patients requiring general anesthesia, lung-protective ventilation can prevent postoperative pulmonary complications, which are associated with higher morbidity, mortality, and prolonged hospital stay. Appl...

    Authors: Helene Selpien, Christine Eimer, David Thunecke, Jann Penon, Dirk Schädler, Ingmar Lautenschläger, Henning Ohnesorge and Tobias Becher
    Citation: Trials 2024 25:282
  30. It is crucial to include a wide range of the population in clinical trials for the outcome to be applicable in real-world settings. Existing literature indicates that under-served groups, including disabled pe...

    Authors: Yoshiko Sakuma, Marie L. E. Miller, Daphne S. Babalis, Alex Baker, Meena Reddi, Aisha Anjum, Jane Bruton, Kathryn N Jones, Umm Zeinab Mulla and Henock Taddese
    Citation: Trials 2024 25:281
  31. Neonatal mortality in India has fallen steadily and was estimated to be 24 per 1000 live births in the year 2017. However, neonatal mortality remains high in rural parts of the country. The Community Health Pr...

    Authors: Nicholas Magill, Siddharudha Shivalli, Ila Fazzio, Diana Elbourne, Suzanne Keddie, Padmanabh Reddy, Rakhi Nair, Madan Gopal, Sridevi Karnati, Harshavardhan Reddy, Peter Boone and Chris Frost
    Citation: Trials 2024 25:280
  32. Allergic rhinitis is a chronic respiratory disorder that significantly impacts patients’ quality of life (QoL) and work performance. Pharmacists are recognized as suitable professionals to provide patient educ...

    Authors: Chii-Chii Chew, Xin-Jie Lim, Pathma Letchumanan, Doris George, Philip Rajan and Chee Ping Chong
    Citation: Trials 2024 25:279
  33. To ensure optimal coordination of the EU-funded COVID-19 platform trials, a double coordination mechanism was established. It included the Trial Coordination Board (TCB) to promote the dialogue between investi...

    Authors: Jacques Demotes, Victoria Charlotte Simensen, Keiko Ueda, Sareema Javaid, Paula Garcia, Burç Aydin and John-Arne Røttingen
    Citation: Trials 2024 25:278
  34. Mental health issues are common among patients with chronic physical conditions, affecting approximately one in five patients. Poor mental health is associated with worse disease outcomes and increased mortali...

    Authors: Anne Søjbjerg, Anna Mygind, Stinne Eika Rasmussen, Bo Christensen, Anette Fischer Pedersen, Helle Terkildsen Maindal, Viola Burau and Kaj Sparle Christensen
    Citation: Trials 2024 25:277
  35. Early, rapid, and accurate pathogen diagnosis can help clinicians select targeted treatment options, thus improving prognosis and reducing mortality rates of severe pneumonia. Metagenomic next-generation seque...

    Authors: Xiao Song, Hui Jiang, Liang Zong, Di Shi and Huadong Zhu
    Citation: Trials 2024 25:276
  36. Parkinson’s disease (PD) is a progressive, neurodegenerative illness marked by the loss of dopaminergic neurons, causing motor symptoms. Oral levodopa replacement therapy remains the gold standard in the treat...

    Authors: Chuanyu Zhong, Ning Guo, Canfang Hu, Ruilong Ni, Xiaojie Zhang, Zheying Meng, Taotao Liu, Siqi Ding, Wanhai Ding, Yuwu Zhao, Li Cao and Yuanyi Zheng
    Citation: Trials 2024 25:275
  37. Recent developments suggest that neurosteroids may achieve rapid antidepressant effects. As such, neurosteroidogenesis mediated by the translocator protein 18 kDa (TSPO) might constitute a promising option for...

    Authors: Lisa-Marie Brunner, Marco Riebel, Simon Wein, Michael Koller, Florian Zeman, Gunnar Huppertz, Tanja Emmer, Yvonne Eberhardt, Jens Schwarzbach, Rainer Rupprecht and Caroline Nothdurfter
    Citation: Trials 2024 25:274
  38. Macular edema (ME) results from hyperpermeability of retinal vessels, leading to chronic extravasation of plasma components into the retina and hence potentially severe visual acuity loss. Current standard of ...

    Authors: Bénédicte Dupas, Daniela Castro-Farias, Jean-François Girmens, Ali Eginay, Aude Couturier, Frederic Villeroy, Marie-Noëlle Delyfer, Catherine Creuzot-Garcher, Audrey Giocanti-Auregan, Laurence Béral, Carl Arndt, Charles Mesnard, Eric Vicaut, Philippe Chaumet-Riffaud, Isabelle Durand-Zaleski and Michel Paques
    Citation: Trials 2024 25:273
  39. Children with sensitization against foods have to be orally food-challenged before eating these foods for the first time. However, the waiting time for an oral food challenge (OFC) in Germany is about 3–6 mont...

    Authors: Birgit Kalb, Lara Meixner, Stephanie Heller, Sabine Dölle-Bierke, Stephanie Roll, Tatjana Tissen-Diabaté, Susanne Lau, Sofia Forslund, Ingo Marenholz, Young-Ae Lee, Andreas Thiel, Magda Babina, Jörg Scheffel, Margitta Worm and Kirsten Beyer
    Citation: Trials 2024 25:272
  40. The World Health Organization recommends universal iron supplementation for children aged 6–23 months in countries where anaemia is seen in over 40% of the population. Conventional ferrous salts have low effic...

    Authors: Mamadou Bah, Hans Verhoef, Emmanuel Okoh, Abdoulie Bah, Andrew M. Prentice and Carla Cerami
    Citation: Trials 2024 25:270
  41. Treatment effects of conventional approaches with antipsychotics or psychosocial interventions are limited when it comes to reducing negative and cognitive symptoms in schizophrenia. While there is emerging cl...

    Authors: Gábor Csukly, Boglárka Orbán-Szigeti, Karolin Suri, Réka Zsigmond, Levente Hermán, Viktória Simon, Anita Kabaji, Barnabás Bata, Péter Hársfalvi, Edit Vass, Éva Csibri, Kinga Farkas and János Réthelyi
    Citation: Trials 2024 25:269
  42. Due to faster recovery and lower morbidity rates, laparoscopy has become the gold standard in elective colorectal surgery for both the benign and malignant forms of the disease. A substantial proportion of col...

    Authors: Marie T. Grönroos-Korhonen and Jyrki A. O. Kössi
    Citation: Trials 2024 25:268
  43. Complete tooth loss is a significant global oral health issue, particularly impacting older individuals with lower socioeconomic status. Computer-assisted technologies enhance oral healthcare access by the eld...

    Authors: Dana Jafarpour, Nesma El-Amier, Jocelyne Feine, Christophe Bedos, Samer Abi-Nader, Shahrokh Esfandiari, Tibor Shuster, Elizabeth Zimmermann and Raphael de Souza
    Citation: Trials 2024 25:267
  44. About one third of patients with depression are in a condition that can be termed as “difficult-to-treat”. Some evidence suggests that difficult-to-treat depression is associated with a higher frequency of chi...

    Authors: Ida-Marie T. P. Arendt, Matthias Gondan, Sophie Juul, Lene Halling Hastrup, Carsten Hjorthøj, Bo Bach, Poul Videbech, Martin Balslev Jørgensen and Stine Bjerrum Moeller
    Citation: Trials 2024 25:266
  45. Liver disease is within the top five causes of premature death in adults. Deaths caused by complications of cirrhosis continue to rise, whilst deaths related to other non-liver disease areas are declining. Por...

    Authors: Vishal C. Patel, Mark J. McPhail, Ruhama Uddin, Hassan Jafari, Vanessa Lawrence, Clair Le Boutillier, James Shearer, Nahel Yaziji, Angela Cape, Haroon Ahmed, Christopher Ward, Peter Walsh, Kevin Besly, Ane Zamalloa, Joanna Kelly and Ben Carter
    Citation: Trials 2024 25:265
  46. Perinatal substance use can have significant adverse effects on maternal and child health and family stability. Few interventions are specifically designed to address this significant public health problem. Th...

    Authors: Erin J. Maher, Susan A. Stoner, Julie Gerlinger, A. C. Ferraro and Heather Lepper-Pappan
    Citation: Trials 2024 25:264
  47. n-of-1 trials are a type of crossover trial designed to optimise the evaluation of health technologies in individual patients. This trial design may be considered for the evaluation of health technologies in r...

    Authors: Olivia Hawksworth, Robin Chatters, Steven Julious, Andrew Cook, Katie Biggs, Kiera Solaiman, Michael C. H. Quah and Sxe Chang Cheong
    Citation: Trials 2024 25:263

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