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  1. Sexually transmitted infections (STIs) during pregnancy are associated with adverse birth outcomes, including preterm birth, low birth weight, perinatal death, and congenital infections such as increased mothe...

    Authors: Andrew Medina-Marino, Susan Cleary, Christina A. Muzny, Christopher Taylor, Ashutosh Tamhane, Phuti Ngwepe, Charl Bezuidenhout, Shelley N. Facente, Koleka Mlisana, Remco P. H. Peters and Jeffrey D. Klausner
    Citation: Trials 2022 23:441
    Content type: Study protocol Published on:

  2. Multifocal atrophic gastritis and intestinal metaplasia are considered to be important links in the gastric precancerous cascade. However, there are no specific drugs for these conditions. Although many studie...

    Authors: Zhijian Gu, Qingling Jia, Jun Cong, Rong Cen, Yongqi Chen, Chenheng Wu, Biao Gong, Xudong Tang and Jianghong Ling
    Citation: Trials 2022 23:437
    Content type: Study protocol Published on:

  3. The optimal preoperative preparation for elective colorectal cancer surgery has been debated in academic circles for decades. Previously, several expert teams have conducted studies on whether preoperative mec...

    Authors: Rui Qi Gao, Wei Dong Wang, Peng Fei Yu, Zhen Chang Mo, Dan Hong Dong, Xi Sheng Yang, Xiao Hua Li and Gang Ji
    Citation: Trials 2022 23:436
    Content type: Study protocol Published on:

  4. Tinnitus is a highly prevalent symptom, affecting 10–15% of the adult population. Tinnitus influenced by alterations in somatosensory afference from the neck or jaw is referred to as somatic tinnitus (ST). ST ...

    Authors: Sara Demoen, Laure Jacquemin, Annick Timmermans, Vincent Van Rompaey, Olivier Vanderveken, Hanne Vermeersch, Iris Joossen, Julie Van Eetvelde, Winfried Schlee, Wim Marneffe, Janis Luyten, Annick Gilles and Sarah Michiels
    Citation: Trials 2022 23:435
    Content type: Study protocol Published on:

  5. Attention-deficit/hyperactivity disorder (ADHD) is the most common behavioral disorder in childhood and adolescence. A number of these patients do not respond to the current pharmacological treatments and ther...

    Authors: Haide Golsorkhi, Mostafa Qorbani, Mohammad Kamalinejad, Saeideh Sabbaghzadegan, Mohsen Bahrami, Mohammad Vafaee-Shahi, Hadi Montazerlotfelahi, Elham Abniki and Majid Dadmehr
    Citation: Trials 2022 23:434
    Content type: Study protocol Published on:

  6. Type 1 diabetes (T1D) places an extraordinary burden on individuals and their families, as well as on the healthcare system. Despite recent advances in glucose sensors and insulin pump technology, only a minor...

    Authors: M. Waibel, H. E. Thomas, J. M. Wentworth, J. J. Couper, R. J. MacIsaac, F. J. Cameron, M. So, B. Krishnamurthy, M. C. Doyle and T. W. Kay
    Citation: Trials 2022 23:433
    Content type: Study protocol Published on:

  7. Child maltreatment recidivism substantially increases the likelihood of adverse life outcomes, but there is little evidence that family preservation services are effective at reducing recidivism. Mothers in ch...

    Authors: Michael Lindsey, Kathrine Sullivan, Claude Chemtob, Kelly Ancharski, James Jaccard, Marylène Cloitre, Anthony Urquiza, Susan Timmer, Mercedes Okosi and Debra Kaplan
    Citation: Trials 2022 23:432
    Content type: Study protocol Published on:

  8. Challenging behaviours, in particular aggressive behaviours, are prevalent among people with intellectual developmental disabilities. Predictors of challenging behaviours are numerous, including past history o...

    Authors: Najat Khalifa, Emily R. Hawken, Andrew Bickle, Mariel Cabrera, Travis Heath, Andrew Drury, Jessica Jones and Muhammad Ayub
    Citation: Trials 2022 23:431
    Content type: Study protocol Published on:

  9. Despite advances in surgical and postoperative care, myocardial injury or infarction (MI) is still a common complication in patients undergoing coronary artery bypass surgery (CABG). Several studies that aimed...

    Authors: Hye Rim Na, O Sung Kwon, Joon Kyu Kang, Yong Han Kim and Ju Yong Lim
    Citation: Trials 2022 23:430
    Content type: Study protocol Published on:

  10. People with psychosis have high rates of trauma, with a post-traumatic stress disorder (PTSD) prevalence rate of approximately 15%, which exacerbates psychotic symptoms such as delusions and hallucinations. Pi...

    Authors: Emmanuelle Peters, Amy Hardy, Robert Dudley, Filippo Varese, Kathryn Greenwood, Craig Steel, Richard Emsley, Nadine Keen, Samantha Bowe, Sarah Swan, Raphael Underwood, Eleanor Longden, Sarah Byford, Laura Potts, Margaret Heslin, Nick Grey…
    Citation: Trials 2022 23:429
    Content type: Study protocol Published on:

  11. Early-onset sepsis is an important cause of neonatal morbidity and mortality in the preterm population. Infants perceived to be at increased risk for early-onset sepsis are often treated empirically with broad...

    Authors: Michael J. Morowitz, Anup C. Katheria, Richard A. Polin, Elizabeth Pace, David T. Huang, Chung-Chou H. Chang and Johathan G. Yabes
    Citation: Trials 2022 23:428
    Content type: Study protocol Published on:

  12. Inappropriate antibiotic use can cause harm and promote antimicrobial resistance, which has been declared a major health challenge by the World Health Organization. In Australian residential aged care faciliti...

    Authors: Nazanin Falconer, David L. Paterson, Nancye Peel, Alyssa Welch, Christopher Freeman, Ellen Burkett, Ruth Hubbard, Tracy Comans, Leila Shafiee Hanjani, Elaine Pascoe, Carmel Hawley and Leonard Gray
    Citation: Trials 2022 23:427
    Content type: Study protocol Published on:

  13. Cognitive behavioral therapy is the first-line treatment for patients with panic disorder (PD) and agoraphobia (AG). Yet, many patients remain untreated due to limited treatment resources. Digital self-guided ...

    Authors: Jari Planert, Alla Machulska, Anne-Sophie Hildebrand, Kati Roesmann, Esra Otto and Tim Klucken
    Citation: Trials 2022 23:426
    Content type: Study protocol Published on:

  14. The etiology of neck pain is multifactorial and includes personal and work-related factors such as age, sex, wrong postures, and repeated strains. Studies based on bio-psychosocial model also link chronic neck...

    Authors: M. Monticone, S. Simone Vullo, L. I. Lecca, F. Meloni, I. Portoghese and M. Campagna
    Citation: Trials 2022 23:425
    Content type: Study protocol Published on:

  15. The COVID-19 pandemic has considerably disrupted nearly all aspects of daily life, including healthcare delivery and clinical research. Because pragmatic clinical trials are often embedded within healthcare de...

    Authors: Emily C. O’Brien, Jeremy Sugarman, Kevin P. Weinfurt, Eric B. Larson, Patrick J. Heagerty, Adrian F. Hernandez and Lesley H. Curtis
    Citation: Trials 2022 23:424
    Content type: Research Published on:

  16. The specific use of methylprednisolone in severe community-acquired pneumonia (SCAP) has not yet formed a consensus. It is not clear whether the clinical efficacy of methylprednisolone in SCAP is dose-dependen...

    Authors: Shukun Hong, Hongye Wang, Jian Liu and Lujun Qiao
    Citation: Trials 2022 23:423
    Content type: Study protocol Published on:

  17. Successful pain management after outpatient surgery requires proper education leading to correct decisions on the analgesics use at home. Despite different strategies adopted, up to ½ of patients receive littl...

    Authors: Mikhail Dziadzko, Axelle Bouteleux, Raphael Minjard, Jack Harich, Fanny Joubert, Pierre Pradat, Solene Pantel and Frederic Aubrun
    Citation: Trials 2022 23:422
    Content type: Study protocol Published on:

  18. Patients with wake-up ischemic stroke are frequently excluded from thrombolytic treatment due to unknown symptom onset time and limited availability of advanced imaging modalities. The Tenecteplase in Wake-up ...

    Authors: Agnethe Eltoft, Tom Wilsgaard, Melinda B. Roaldsen, Mary-Helen Søyland, Erik Lundström, Jesper Petersson, Bent Indredavik, Jukka Putaala, Hanne Christensen, Janika Kõrv, Dalius Jatužis, Stefan T. Engelter, Gian Marco De Marchis, David J. Werring, Thompson Robinson, Arnstein Tveiten…
    Citation: Trials 2022 23:421
    Content type: Update Published on:

  19. Hand-foot syndrome (HFS) is a common cutaneous side effect of capecitabine therapy. Apart from oral cyclooxygenase-2 (COX-2) inhibitor (celecoxib), there are no proven strategies for the prevention of HFS. How...

    Authors: Akhil Santhosh, Akash Kumar, Raja Pramanik, Ajay Gogia, Chandra Prakash Prasad, Ishaan Gupta, Nishkarsh Gupta, Winson Y. Cheung, Ravindra Mohan Pandey, Atul Sharma and Atul Batra
    Citation: Trials 2022 23:420
    Content type: Study protocol Published on:

  20. Kidney failure prevalence is increasing worldwide. Haemodialysis, peritoneal dialysis or kidney transplantation are undertaken to extend life with kidney failure. People receiving haemodialysis commonly experi...

    Authors: Lavern Greenham, Paul N. Bennett, Kathryn Dansie, Andrea K. Viecelli, Shilpanjali Jesudason, Rebecca Mister, Brendan Smyth, Portia Westall, Samuel Herzog, Chris Brown, William Handke, Suetonia C. Palmer, Fergus J. Caskey, Cecile Couchoud, John Simes, Stephen P. McDonald…
    Citation: Trials 2022 23:419
    Content type: Study protocol Published on:

  21. Tinnitus is the result of aberrant neuronal activity. As a novel treatment form, neuromodulation is used to modify neuronal activity of brain areas involved in tinnitus generation. Among the different forms of...

    Authors: Mariana Lopes Martins, Tobias Kleinjung, Martin Meyer, Vithushika Raveenthiran, Zino Wellauer, Nicole Peter and Patrick Neff
    Citation: Trials 2022 23:418
    Content type: Study protocol Published on:

  22. In low- and middle-income countries (LMIC), there is a substantial gap in the treatment of mental and behavioral health problems, which is particularly detrimental to adolescents and young adults (AYA). The Co...

    Authors: Caleb J. Figge, Jeremy C. Kane, Stephanie Skavenski, Emily Haroz, Mwamba Mwenge, Saphira Mulemba, Luke R. Aldridge, Michael J. Vinikoor, Anjali Sharma, Sachi Inoue, Ravi Paul, Francis Simenda, Kristina Metz, Carolyn Bolton, Christopher Kemp, Samuel Bosomprah…
    Citation: Trials 2022 23:417
    Content type: Study protocol Published on:

  23. Plasmodium vivax forms dormant liver stages that can reactivate weeks or months following an acute infection. Recurrent infections are often associated with a febrile illness and can cause a cumulative risk of s...

    Authors: Kamala Thriemer, Tamiru Shibru Degaga, Michael Christian, Mohammad Shafiul Alam, Benedikt Ley, Mohammad Sharif Hossain, Mohammad Golam Kibria, Tedla Teferi Tego, Dagimawie Tadesse Abate, Sophie Weston, Amalia Karahalios, Megha Rajasekhar, Julie A. Simpson, Angela Rumaseb, Hellen Mnjala, Grant Lee…
    Citation: Trials 2022 23:416
    Content type: Study protocol Published on:

  24. A single cycle (two repeated treatments) with intrathecal autologous bone marrow-derived mesenchymal stem cells (BM-MSCs, 26-day interval) showed safety and provided therapeutic benefit lasting 6 months in pat...

    Authors: Jae-Yong Nam, Tae Yong Lee, Kwijoo Kim, Sehwan Chun, Min Sung Kim, Jin-Hong Shin, Jung-Joon Sung, Byoung Joon Kim, Byung-Jo Kim, Ki-Wook Oh, Kyung Suk Kim and Seung Hyun Kim
    Citation: Trials 2022 23:415
    Content type: Study protocol Published on:

  25. The INNODIA consortium has established a pan-European infrastructure using validated centres to prospectively evaluate clinical data from individuals with newly diagnosed type 1 diabetes combined with centrali...

    Authors: David B. Dunger, Sylvaine F. A. Bruggraber, Adrian P. Mander, M. Loredana Marcovecchio, Timothy Tree, Piotr Jaroslaw Chmura, Mikael Knip, Anke M. Schulte and Chantal Mathieu
    Citation: Trials 2022 23:414
    Content type: Study protocol Published on:

  26. Elderly population in low- and middle-income countries is rapidly growing, which indicates an increase in the number of dependent people needing long-term care. Caring for the elderly is difficult and stressfu...

    Authors: Fatemeh Rahimi, Elham Shakibazadeh, Mahnaz Ashoorkhani, Hamed Hosseini and Mahshid Foroughan
    Citation: Trials 2022 23:413
    Content type: Study protocol Published on:

  27. Clinical decision support systems (CDSS) are low-cost, scalable tools with the potential to improve guideline-based antihypertensive treatment in primary care, but their effectiveness needs to be tested, espec...

    Authors: Jiali Song, Xiuling Wang, Bin Wang, Yan Gao, Jiamin Liu, Haibo Zhang, Xi Li, Jing Li, Ji-Guang Wang, Jun Cai, Jeph Herrin, Jane Armitage, Harlan M. Krumholz and Xin Zheng
    Citation: Trials 2022 23:412
    Content type: Study protocol Published on:

  28. Patients with acute conditions often lack the capacity to provide informed consent, and narrow therapeutic windows mean there is no time to seek consent from surrogates prior to treatment being commenced. One ...

    Authors: Aran Fitzpatrick, Fiona Wood and Victoria Shepherd
    Citation: Trials 2022 23:411
    Content type: Review Published on:

  29. The effectiveness of psychotropic medication on behavioral and psychological symptoms of dementia (BPSD) is limited, while associated with a higher risk of adverse events. Non-pharmacological treatment of BPSD...

    Authors: Pernille Hølmkjær, Anne Holm, Gritt Overbeck and Maarten Pieter Rozing
    Citation: Trials 2022 23:410
    Content type: Study protocol Published on:

  30. Phase 1 drug trials are popular treatment options for patients with advanced disease, despite the greater levels of uncertainty associated with them. However, their meaning and consequences for patient-partici...

    Authors: Kate Escritt, Mala Mann, Annmarie Nelson and Emily Harrop
    Citation: Trials 2022 23:409
    Content type: Review Published on:

  31. Nonspecific neck pain is a multifactorial and very common condition in adult individuals, traditional acupuncture (TA) and laser acupuncture (LA) may be treatment options for certain individuals in such a con...

    Authors: Rafaela Peron, Érika Patrícia Rampazo and Richard Eloin Liebano
    Citation: Trials 2022 23:408
    Content type: Study protocol Published on:

  32. Staphylococcus aureus bacteremia is a life-threatening infection and leading cause of infective endocarditis, with mortality rates of 15–50%. Treatment typically requires prolonged administration of parenteral t...

    Authors: Nicholas A. Turner, Smitha Zaharoff, Heather King, Scott Evans, Toshimitsu Hamasaki, Thomas Lodise, Varduhi Ghazaryan, Tatiana Beresnev, Todd Riccobene, Rinal Patel, Sarah B. Doernberg, Urania Rappo, Vance G. Fowler Jr and Thomas L. Holland
    Citation: Trials 2022 23:407
    Content type: Study protocol Published on:

  33. Administration of sedative and opioid medications to patients receiving mechanical ventilatory support in the intensive care unit is a common clinical practice.

    Authors: Linda L. Chlan, Craig R. Weinert, Mary Fran Tracy, Debra J. Skaar, Ognjen Gajic, Jessica Ask and Jay Mandrekar
    Citation: Trials 2022 23:406
    Content type: Study protocol Published on:

  34. Although life-saving in selected patients, ECMO treatment still has high mortality which for a large part is due to treatment-related complications. A feared complication is ischemic stroke for which heparin i...

    Authors: Olivier van Minnen, Annemieke Oude Lansink-Hartgring, Bas van den Boogaard, Judith van den Brule, Pierre Bulpa, Jeroen J. H. Bunge, Thijs S. R. Delnoij, Carlos V. Elzo Kraemer, Marijn Kuijpers, Bernard Lambermont, Jacinta J. Maas, Jesse de Metz, Isabelle Michaux, Ineke van de Pol, Marcel van de Poll, S. Jorinde Raasveld…
    Citation: Trials 2022 23:405
    Content type: Study protocol Published on:

  35. Common and frequent as acute pain is, it is often underestimated and undertreated in older people with dementia in nursing homes and inadequate pain management remains an issue.

    Authors: Xiao-Min Chai, Hong-Yan Shi, Jun-Jun Zhang, Lei Wang, Hai-Xiang Gao, Ya-Liang Dai, Lu-Lu Gao, Jian-Qiang Yu, Yu-Xiang Li and Carol Chunfeng Wang
    Citation: Trials 2022 23:404
    Content type: Study protocol Published on:

  36. A multitude of different diseases—benign and malign—can require surgery of the liver. The liver is an especially challenging organ for resection planning due to its unique and interindividually variable anatom...

    Authors: Tobias Huber, Laura Isabel Hanke, Christian Boedecker, Lukas Vradelis, Janine Baumgart, Stefan Heinrich, Fabian Bartsch, Jens Mittler, Alicia Schulze, Christian Hansen, Florentine Hüttl and Hauke Lang
    Citation: Trials 2022 23:403
    Content type: Study protocol Published on:

  37. There is an urgent need for evidence on how interventions can prevent or mitigate cancer-related financial hardship. Our objectives are to compare self-reported financial hardship, quality of life, and health ...

    Authors: Nora B. Henrikson, Melissa L. Anderson, John Dickerson, John J. Ewing, Robin Garcia, Erin Keast, Deborah A. King, Cara Lewis, Blake Locher, Carmit McMullen, Consuelo M. Norris, Amanda F. Petrik, Arvind Ramaprasan, Jennifer S. Rivelli, Jennifer L. Schneider, Lisa Shulman…
    Citation: Trials 2022 23:402
    Content type: Study protocol Published on:

  38. Mesenchymal stromal cells (MSCs) may be of benefit in ARDS due to immunomodulatory and reparative properties. This trial investigates a novel CD362 enriched umbilical cord derived MSC product (REALIST ORBCEL-C...

    Authors: Ellen Gorman, Manu Shankar-Hari, Phil Hopkins, William S. Tunnicliffe, Gavin D. Perkins, Jonathan Silversides, Peter McGuigan, Colette Jackson, Roisin Boyle, Jamie McFerran, Cliona McDowell, Christina Campbell, Margaret McFarland, Jon Smythe, Jacqui Thompson, Barry Williams…
    Citation: Trials 2022 23:401
    Content type: Study protocol Published on:

    The Letter to this article has been published in Trials 2020 21:462

  39. This update describes changes to the Brief Educational Tool to Enhance Recovery (BETTER) trial in response to the COVID-19 pandemic.

    Authors: Karen Hurka-Richardson, Timothy F. Platts-Mills, Samuel A. McLean, Morris Weinberger, Sally C. Stearns, Montika Bush, Eugenia Quackenbush, Srihari Chari, Aileen Aylward, Kurt Kroenke, Robert D. Kerns, Mark A. Weaver, Francis J. Keefe, David Berkoff and Michelle L. Meyer
    Citation: Trials 2022 23:400
    Content type: Update Published on:

  40. People living with HIV (PLHIV) have an increased risk of developing active tuberculosis (TB). To reduce the burden of TB among PLHIV, the World Health Organization (WHO) recommends systematic TB screening foll...

    Authors: Fred C. Semitala, Lelia H. Chaisson, David W. Dowdy, Derek T. Armstrong, Bishop Opira, Kyomugisha Aman, Moses Kamya, Patrick P. J. Phillips and Christina Yoon
    Citation: Trials 2022 23:399
    Content type: Study protocol Published on:

  41. Multi-site studies in stroke rehabilitation are important for determining whether a technology and/or treatment can be successfully administered by sites other than the originating site and with similar positi...

    Authors: Jayme S. Knutson, Amy S. Friedl, Kristine M. Hansen, Mary Y. Harley, A. M. Barrett, Preeti Raghavan, Ela B. Plow, Douglas D. Gunzler and John Chae
    Citation: Trials 2022 23:397
    Content type: Study protocol Published on:

  42. Social anxiety disorder (SAD) is a highly prevalent mental disorder associated with enormous stress and suffering. Cognitive behavior therapy (CBT) is the first-line treatment for SAD, yet its accessibility is...

    Authors: Anne Sophie Hildebrand, Kati Roesmann, Jari Planert, Alla Machulska, Esra Otto and Tim Klucken
    Citation: Trials 2022 23:395
    Content type: Study protocol Published on:

  43. Qualitative research can enhance the design, conduct and interpretation of trials. Despite this, few trials incorporate qualitative methods, and those that do may not realise their full potential. In this comm...

    Authors: Alison Powell, Sarah Hoare, Rakesh Modi, Kate Williams, Andrew Dymond, Cheryl Chapman, Simon Griffin, Jonathan Mant and Jenni Burt
    Citation: Trials 2022 23:394
    Content type: Commentary Published on:

  44. Covered stent has become one of the mainstream therapies for aortoiliac obstructive disease (AIOD), with a higher patency rate than bare metal stent. Covered balloon-expandable (CBE) stent can be placed more a...

    Authors: Yuhan Qi, Jiarong Wang, Jichun Zhao, Bing Huang, Fei Xiong, Xiaojiong Du, Xiyang Chen, Qiang Guo, Tiehao Wang and Ding Yuan
    Citation: Trials 2022 23:392
    Content type: Study protocol Published on:

  45. Childbirth is a unique experience that affects women’s life. Midwives can play an effective role in creating positive birth experiences for women using non-pharmacological and supportive methods. Accordingly, ...

    Authors: Parvaneh Sharifipour, Masoomeh Kheirkhah, Mojgan Rajati and Hamid Haghani
    Citation: Trials 2022 23:391
    Content type: Research Published on:

  46. The COVID-19 pandemic has posed daunting challenges when conducting clinical research. Adopting new technologies such as remote electronic consent (e-Consent) can help overcome them. However, guidelines for e-...

    Authors: Ricardo Almeida-Magana, Hanna Maroof, Jack Grierson, Rosie Clow, Eoin Dinneen, Tarek Al-Hammouri, Nicola Muirhead, Chris Brew-Graves, John Kelly and Greg Shaw
    Citation: Trials 2022 23:388
    Content type: Methodology Published on:

  47. Acute gouty arthritis (AGA) is an inflammatory arthritis clinically characterized by severe pain, swelling, and restricted movement of joints, which may cause physical disability and decrease quality of life. ...

    Authors: Ya-xi Shang, Xia Dong, Zhi-min Xie, Xiao-peng Li, Xin-chang Wang, Ji-yong Huang, Shu-feng Wei, Yuan Liu and Jian-ping Liu
    Citation: Trials 2022 23:387
    Content type: Study protocol Published on:

  48. Musculoskeletal pain (MP) has today intensified in a large proportion of music students in Iran. Poor posture while playing an instrument is thus assumed as a very significant risk factor affecting such a cond...

    Authors: Zahra Akbari-Chehrehbargh and Sedigheh Sadat Tavafian
    Citation: Trials 2022 23:386
    Content type: Study protocol Published on:

  49. Patient recruitment for clinical trials is challenging—only approximately one third of all trials recruit their participants as planned. The pharmaceutical industry’s views on recruitment success have not been...

    Authors: Niina Laaksonen, Mia Bengtström, Anna Axelin, Juuso Blomster, Mika Scheinin and Risto Huupponen
    Citation: Trials 2022 23:385
    Content type: Methodology Published on:

  50. This study is a confirmatory efficacy trial of two treatments for winter seasonal affective disorder (SAD): SAD-tailored group cognitive-behavioral therapy (CBT-SAD) and light therapy (LT). In our previous eff...

    Authors: Kelly J. Rohan, Peter L. Franzen, Kathryn A. Roeckelin, Greg J. Siegle, David J. Kolko, Teodor T. Postolache and Pamela M. Vacek
    Citation: Trials 2022 23:383
    Content type: Study protocol Published on:
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