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Improving mental health in chronic care in general practice: study protocol for a cluster-randomised controlled trial of the Healthy Mind intervention Trials (IF 2.5) Pub Date : 2024-04-23 Anne Søjbjerg, Anna Mygind, Stinne Eika Rasmussen, Bo Christensen, Anette Fischer Pedersen, Helle Terkildsen Maindal, Viola Burau, Kaj Sparle Christensen
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 mortality. Problem-solving therapy (PST) may be a suitable treatment for targeting poor mental health in these patients. This study protocol describes a randomised controlled trial of the Healthy Mind
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The clinical value of mNGS of bronchoalveolar lavage fluid versus traditional microbiological tests for pathogen identification and prognosis of severe pneumonia (NT-BALF):study protocol for a prospective multi-center randomized clinical trial Trials (IF 2.5) Pub Date : 2024-04-22 Xiao Song, Hui Jiang, Liang Zong, Di Shi, Huadong Zhu
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 sequencing (mNGS) has a higher sensitivity and broader pathogen spectrum than traditional microbiological tests. However, the effects of mNGS-based antimicrobial treatment procedures on clinical outcomes
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Efficacy of Wearable low-intensity pulsed Ultrasound treatment in the Movement disorder in Parkinson’s disease (the SWUMP trial): protocol for a single-site, double-blind, randomized controlled trial Trials (IF 2.5) Pub Date : 2024-04-22 Chuanyu Zhong, Ning Guo, Canfang Hu, Ruilong Ni, Xiaojie Zhang, Zheying Meng, Taotao Liu, Siqi Ding, Wanhai Ding, Yuwu Zhao, Li Cao, Yuanyi Zheng
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 treatment of PD. It is, nevertheless, a symptomatic treatment. There is currently no effective treatment for PD. Therefore, new therapies for PD are highly desirable. Low-intensity pulsed ultrasound
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The translocator protein 18kDa ligand etifoxine in the treatment of depressive disorders—a double-blind, randomized, placebo-controlled proof-of-concept study Trials (IF 2.5) Pub Date : 2024-04-22 Lisa-Marie Brunner, Marco Riebel, Simon Wein, Michael Koller, Florian Zeman, Gunnar Huppertz, Tanja Emmer, Yvonne Eberhardt, Jens Schwarzbach, Rainer Rupprecht, Caroline Nothdurfter
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 the treatment of depression. Therefore, the current clinical trial aims to get the first evidence of whether TPSO ligands promote rapid antidepressant effects. Furthermore, we study which mechanisms
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Photocoagulation or sham laser in addition to conventional anti-VEGF therapy in macular edema associated with TelCaps due to diabetic macular edema or retinal vein occlusion (TalaDME): a study protocol for a multicentric, French, two-group, non-commercial, active-control, observer-masked, non-inferiority, randomized controlled clinical trial Trials (IF 2.5) Pub Date : 2024-04-22 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, Michel Paques
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 care consists in using intravitreal injections (IVI), which results in a significant medical and economic burden. During diabetic retinopathy (DR) or retinal vein occlusion (RVO), it has recently
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Tolerance induction through early feeding to prevent food allergy in infants and children with sensitization against food allergens (TIFFANI): rationale, study design, and methods of a randomized controlled trial Trials (IF 2.5) Pub Date : 2024-04-19 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, Kirsten Beyer
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 months. In contrast, there are hints that an early introduction of allergenic foods might be protective regarding the development of food allergy. The aim of this clinical trial is therefore to investigate
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A maturity model for the scientific review of clinical trial designs and their informativeness Trials (IF 2.5) Pub Date : 2024-04-19 S Dolley, T Norman, D McNair, D Hartman
Informativeness, in the context of clinical trials, defines whether a study’s results definitively answer its research questions with meaningful next steps. Many clinical trials end uninformatively. Clinical trial protocols are required to go through reviews in regulatory and ethical domains: areas that focus on specifics outside of trial design, biostatistics, and research methods. Private foundations
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Haem iron versus ferrous iron salts to treat iron deficiency anaemia in Gambian children: protocol for randomised controlled trial {1} Trials (IF 2.5) Pub Date : 2024-04-19 Mamadou Bah, Hans Verhoef, Emmanuel Okoh, Abdoulie Bah, Andrew M. Prentice, Carla Cerami
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 efficacy due to low oral absorption in children with inflammation. Haem iron is more bioavailable, and its absorption may not be decreased by inflammation. This study aims to compare daily supplementation
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Theta-burst rTMS in schizophrenia to ameliorate negative and cognitive symptoms: study protocol for a double-blind, sham-controlled, randomized clinical trial Trials (IF 2.5) Pub Date : 2024-04-17 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, János Réthelyi
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 clinical evidence that new, augmented protocols based on theta-burst stimulation can increase rTMS efficacy dramatically in depression, data on similar augmented therapies are limited in schizophrenia
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LapEmerge trial: study protocol for a laparoscopic approach for emergency colon resection—a multicenter, open label, randomized controlled trial Trials (IF 2.5) Pub Date : 2024-04-17 Marie T. Grönroos-Korhonen, Jyrki A. O. Kössi
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 colorectal operations are, however, carried out in emergency settings, and most of the emergency resections are still performed open. The aim of this study is to compare the laparoscopic versus open
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3D printing vs traditional workflow for the fabrication of mandibular implant overdentures: study protocol for a mixed-methods cross-over RCT Trials (IF 2.5) Pub Date : 2024-04-16 Dana Jafarpour, Nesma El-Amier, Jocelyne Feine, Christophe Bedos, Samer Abi-Nader, Shahrokh Esfandiari, Tibor Shuster, Elizabeth Zimmermann, Raphael de Souza
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 elderly. Despite promising in vitro reports on digital denture materials, evidence from randomized clinical trials (RCTs) is lacking to verify their performance. This cross-over RCT will investigate
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Schema therapy versus treatment as usual for outpatients with difficult-to-treat depression: study protocol for a parallel group randomized clinical trial (DEPRE-ST) Trials (IF 2.5) Pub Date : 2024-04-16 Ida-Marie T. P. Arendt, Matthias Gondan, Sophie Juul, Lene Halling Hastrup, Carsten Hjorthøj, Bo Bach, Poul Videbech, Martin Balslev Jørgensen, Stine Bjerrum Moeller
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 childhood trauma and comorbid personality disorders or accentuated features. However, the condition is understudied, and the effects of psychotherapy for difficult-to-treat depression are currently
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Beta-blockers or Placebo for Primary Prophylaxis (BOPPP) of oesophageal varices: study protocol for a randomised controlled trial Trials (IF 2.5) Pub Date : 2024-04-16 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, Ben Carter
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. Portal hypertension is the primary sequelae of cirrhosis and is associated with the development of variceal haemorrhage, ascites, hepatic encephalopathy and infection, collectively termed hepatic
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Study protocol for a randomized controlled trial of the Parent–Child Assistance Program: a case management and home visiting program for people using substances during pregnancy Trials (IF 2.5) Pub Date : 2024-04-16 Erin J. Maher, Susan A. Stoner, Julie Gerlinger, A. C. Ferraro, Heather Lepper-Pappan
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. The Parent–Child Assistance Program (PCAP) is a 3-year case management and home-visiting intervention that seeks to help birthing persons with at-risk substance use during pregnancy to achieve and
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A methodological review of randomised n-of-1 trials Trials (IF 2.5) Pub Date : 2024-04-16 Olivia Hawksworth, Robin Chatters, Steven Julious, Andrew Cook, Katie Biggs, Kiera Solaiman, Michael C. H. Quah, Sxe Chang Cheong
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 rare conditions where fewer patients are available to take part in research. This review describes the characteristics of randomised n-of-1 trials conducted over the span of 12 years, including
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Educational nutritional intervention to prevent loss of health-related quality of life among older adults after a surgical treatment: design of a randomised controlled trial Trials (IF 2.5) Pub Date : 2024-04-15 Monica Christin Hansen, Lisbeth Uhrenfeldt, Kari Ingstad, Preben U. Pedersen
Disease-related malnutrition after a hospital stay has major consequences for older adults, the healthcare system and society. This study aims to develop and test the effectiveness of an educational video to prevent loss of health-related quality of life among live-at-home older adults after surgical treatment in a hospital. This randomised controlled trial will occur at a regional hospital in Norway
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The (cost-)effectiveness of early intervention (MBT-early) versus standard protocolized treatment (CBT) for emerging borderline personality disorder in adolescents (the EARLY study): a study protocol for a randomized controlled trial Trials (IF 2.5) Pub Date : 2024-04-15 Melissa G. A. Remeeus, Sharon L. Clarke, Dine J. Feenstra, Hester Van Eeren, Maaike L. Smits, Sara Debruyne, Mirjam E. J. Kouijzer, Patrick Luyten, Ron H. J. Scholte, Joost Hutsebaut
Although clinical guidelines prioritize the treatment of depression and anxiety in young persons, there is accumulating evidence that the presence of symptoms of borderline personality disorder (BPD) is associated with the limited effectiveness of these standard treatments. These findings stress the need for interventions addressing early-stage BPD in young people with presenting symptoms of anxiety
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Designing greener participant-centred trials: an analysis of ‘carbon relevant’ factors within items that influence participants’ decisions about trial recruitment and retention Trials (IF 2.5) Pub Date : 2024-04-15 Emilia Piltonen, Beatriz Goulao, Katie Gillies
The World Health Organization have recognised climate change as one of the biggest health threats facing humanity, considering its effects on social and environmental determining factors of health such as clean air, potable water, adequate food and secure shelter [1]. In 2007, the Sustainable Trials Study Group concluded that ‘clinical trials contribute to greenhouse gas emissions, and estimates in
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Probiotic supplementation and risk of necrotizing enterocolitis and mortality among extremely preterm infants—the Probiotics in Extreme Prematurity in Scandinavia (PEPS) trial: study protocol for a multicenter, double-blinded, placebo-controlled, and registry-based randomized controlled trial Trials (IF 2.5) Pub Date : 2024-04-12 Sofia Söderquist Kruth, Carl Willers, Emma Persad, Elisabeth Stoltz Sjöström, Susanne Rautiainen Lagerström, Alexander Rakow
Extremely preterm infants, defined as those born before 28 weeks’ gestational age, are a very vulnerable patient group at high risk for adverse outcomes, such as necrotizing enterocolitis and death. Necrotizing enterocolitis is an inflammatory gastrointestinal disease with high incidence in this cohort and has severe implications on morbidity and mortality. Previous randomized controlled trials have
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The World Health Organization Antenatal CorTicosteroids for Improving Outcomes in preterm Newborns (ACTION-III) Trial: study protocol for a multi-country, multi-centre, double-blind, three-arm, placebo-controlled, individually randomized trial of antenatal corticosteroids for women at high probability of late preterm birth in hospitals in low- resource countries Trials (IF 2.5) Pub Date : 2024-04-12
Preterm birth complications are the leading cause of newborn and under-5 mortality. Over 85% of all preterm births occur in the late preterm period, i.e. between 34 and < 37 weeks of gestation. Antenatal corticosteroids (ACS) prevent mortality and respiratory morbidity when administered to women at high risk of an early preterm birth, i.e. < 34 weeks’ gestation. However, the benefits and risks of ACS
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Supported exercise TrAining for Men wIth prostate caNcer on Androgen deprivation therapy (STAMINA): study protocol for a randomised controlled trial of the clinical and cost-effectiveness of the STAMINA lifestyle intervention compared with optimised usual care, including internal pilot and parallel process evaluation Trials (IF 2.5) Pub Date : 2024-04-12 Emma McNaught, Sophie Reale, Liam Bourke, Janet E. Brown, Michelle Collinson, Florence Day, Jenny Hewison, Amanda J. Farrin, Saïd Ibeggazene, Aidan Q. Innes, Ellen Mason, David Meads, Alison Scope, Chris Taylor, Steph JC. Taylor, Rebecca R. Turner, Derek J. Rosario
UK national clinical guidance recommends that men with prostate cancer on androgen deprivation therapy are offered twice weekly supervised aerobic and resistance exercise to address iatrogenic harm caused by treatment. Very few NHS trusts have established adequate provision of such services. Furthermore, interventions fail to demonstrate sustained behaviour change. The STAMINA lifestyle intervention
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Remote or in-clinic? The effect of service delivery mode on hearing aid output: study protocol for a double-blinded, randomised trial in adults with mild to moderate sensorineural hearing loss Trials (IF 2.5) Pub Date : 2024-04-12 Craig Lett, David Welch, Rosie Dobson
Teleaudiology can potentially improve access to hearing healthcare services. Remote hearing aid fittings offer a new mode of service delivery that removes barriers of geography and access to an audiologist. Real-ear measurements (REMs) are the gold standard for hearing aid output verification but require in-clinic appointments. This study will investigate whether remote hearing aid fittings can provide
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How inclusive were UK-based randomised controlled trials of COVID-19 vaccines? A systematic review investigating enrolment of Black adults and adult ethnic minorities Trials (IF 2.5) Pub Date : 2024-04-12 Hibba Herieka, Daphne Babalis, Evangelia Tzala, Shyam Budhathoki, Nicholas A. Johnson
To establish if Black adults and adult ethnic minorities, defined as any group except White British, were represented in UK-based COVID-19 vaccination randomised controlled trials (RCTs) when compared to corresponding UK population proportions, based on 2011 census data. Systematic review of COVID-19 Randomised Controlled Vaccine Trials United Kingdom Randomised Controlled Trials of COVID-19 vaccines
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Effects of task-based mirror therapy on upper limb motor function in hemiplegia: study protocol for a randomized controlled clinical trial Trials (IF 2.5) Pub Date : 2024-04-11 Hongzhen Liu, Yangjie Xu, Wei Jiang, Fangchao Hu, Yi Zhou, Lu Pan, Feng Zhou, Ying Yin, Botao Tan
Research to date has lacked definitive evidence to determine whether mirror therapy promotes the recovery of upper extremity function after stroke. Considering that previous studies did not stratify patients based on structural retention, this may be one of the reasons for the negative results obtained in many trials. The goal evaluates the efficacy of TBMT (utilizing an innovatively designed mirror)
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Correction: Engaging Black youth in depression and suicide prevention treatment within urban schools: study protocol for a randomized controlled pilot Trials (IF 2.5) Pub Date : 2024-04-11 Michael A. Lindsey, Laura Mufson, Carolina Vélez‑Grau, Tracy Grogan, Damali M. Wilson, Aaron O. Reliford, Meredith Gunlicks‑Stoessel, James Jaccard
Correction: Trials 25, 112 (2024) https://doi.org/10.1186/s13063-024-07947-8 Following publication of the original article [1], we have been notified that the generic SPIRIT diagram was presented as Figure 1, instead of the study’s specific figure. Originally published Figure 1: Correct Figure 1: The original article has been corrected. Lindsey, et al. Engaging Black youth in depression and suicide
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Effectiveness of personalized meal recommendation in improving dietary behaviors of Chinese community-dwelling elders: study protocol for a cluster randomized controlled trial Trials (IF 2.5) Pub Date : 2024-04-11 Zidu Xu, Xiaowei Xu, Lianglong Sun, Zhen Guo, Jianqiang Lai, Lin Kang, Jiao Li
Inappropriate eating behaviors, particularly a lack of food diversity and poor diet quality, have a significant impact on the prognosis of certain chronic conditions and exacerbate these conditions in the community-dwelling elderly population. Current dietary interventions for the elderly have not adequately considered the nutritional needs associated with multiple chronic conditions and personal dietary
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Vitamin D as an intervention for improving quadriceps muscle strength in patients after anterior cruciate ligament reconstruction: study protocol for a randomized double-blinded, placebo-controlled clinical trial Trials (IF 2.5) Pub Date : 2024-04-11 Michael Tim-yun Ong, Xiaomin Lu, Ben Chi-yin Choi, Siu-Wai Wan, Qianwen Wang, Gene Chi-wai Man, Pauline Po-yee Lui, Daniel Tik-Pui Fong, Daniel Kam-wah Mok, Patrick Shu-hang Yung
The goal of anterior cruciate ligament reconstruction (ACLR) is to restore the preinjury level of knee function to return to play (RTP). However, even after completing the rehabilitation programme, some patients may have persistent quadriceps muscle weakness affecting knee function which ultimately leads to a failure in returning to play. Vitamin D has been long recognized for its musculoskeletal effects
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Safety and efficacy of ketorolac in improving the prognosis of acute type A aortic dissection patients: a protocol of a randomized, double-blinded, and placebo-controlled study Trials (IF 2.5) Pub Date : 2024-04-10 Zhikang Lv, Tuo Pan, Haitao Zhang, Yapeng Wang, Yusanjian Matniyaz, Yuxian Tang, Lichong Lu, Dongjin Wang
Acute type A aortic dissection (aTAAD) is a critical and life-threatening condition. Previous research has demonstrated that the use of ketorolac not only reduces the progression, incidence, and severity of aortic aneurysms in animal models, but also decreases postoperative mortality and complications in patients undergoing open abdominal aortic aneurysm replacement. However, there is a lack of studies
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Australasian Malignant PLeural Effusion (AMPLE)-4 trial: study protocol for a multi-centre randomised trial of topical antibiotics prophylaxis for infections of indwelling pleural catheters Trials (IF 2.5) Pub Date : 2024-04-10 Estee P. M. Lau, Matthew Ing, Sona Vekaria, Ai Ling Tan, Chloe Charlesworth, Edward Fysh, Ranjan Shrestha, Elaine L. C. Yap, Nicola A. Smith, Benjamin C. H. Kwan, Tajalli Saghaie, Bapti Roy, John Goddard, Sanjeevan Muruganandan, Arash Badiei, Phan Nguyen, Mohamed Faisal Abdul Hamid, Vineeth George, Deirdre Fitzgerald, Nick Maskell, David Feller-Kopman, Kevin Murray, Aron Chakera, Y C Gary Lee
Malignant pleural effusion (MPE) is a debilitating condition as it commonly causes disabling breathlessness and impairs quality of life (QoL). Indwelling pleural catheter (IPC) offers an effective alternative for the management of MPE. However, IPC-related infections remain a significant concern and there are currently no long-term strategies for their prevention. The Australasian Malignant PLeural
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RISEinFAMILY project: the integration of families at neonatal intensive care units (NICUs) to empower them as primary caregivers: study protocol for a stepped wedge cluster controlled trial Trials (IF 2.5) Pub Date : 2024-04-10 M. T. Alferink, B. Moreno-Sanz, M. Cabrera-Lafuente, E. Ergenekon, T. R. de Haan, A. A. M. W. van Kempen, J. Lakhwani, H. Rabe, G. C. Zaharie, A. Pellicer
Family Integrated Care (FICare) has demonstrated positive outcomes for sick neonates and has alleviated the psychological burden faced by families. FICare involves structured training for professionals and caregivers along with the provision of resources to offer physical and psychological support to parents. However, FICare implementation has been primarily limited to developed countries. It remains
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Validation of the predictive value of BDNF -87 methylation for antidepressant treatment success in severely depressed patients—a randomized rater-blinded trial Trials (IF 2.5) Pub Date : 2024-04-09 Hannah Benedictine Maier, Alexandra Neyazi, Gabriel L. Bundies, Fiona Meyer-Bockenkamp, Stefan Bleich, Hansi Pathak, Yvonne Ziert, Barbara Neuhaus, Franz-Josef Müller, Iris Pollmann, Thomas Illig, Stefanie Mücke, Meike Müller, Brinja Kira Möller, Steffen Oeltze-Jafra, Tim Kacprowski, Jan Voges, Fabian Müntefering, Josef Scheiber, Andreas Reif, Mareike Aichholzer, Christine Reif-Leonhard, Maren Schmidt-Kassow
Brain-derived neurotrophic factor (BDNF) is essential for antidepressant treatment of major depressive disorder (MDD). Our repeated studies suggest that DNA methylation of a specific CpG site in the promoter region of exon IV of the BDNF gene (CpG -87) might be predictive of the efficacy of monoaminergic antidepressants such as selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine
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Effects of cognitive behavioural therapy and bright light therapy for insomnia in youths with eveningness: study protocol for a randomised controlled trial Trials (IF 2.5) Pub Date : 2024-04-09 Shirley Xin Li, Forrest Tin Wai Cheung, Ngan Yin Chan, Joey Wing Yan Chan, Jihui Zhang, Albert Martin Li, Colin A. Espie, Michael Gradisar, Yun-Kwok Wing
Insomnia and eveningness are common and often comorbid conditions in youths. While cognitive behavioural therapy for insomnia (CBT-I) has been suggested as a promising intervention, it remains unclear whether it is sufficient to also address circadian issues in youths. In addition, despite that light has been shown to be effective in phase-shifting one’s circadian rhythm, there has been limited data
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Nutrition and movement to improve quality of life in patients with knee osteoarthritis: the NUMOQUA study protocol for a randomised controlled trial Trials (IF 2.5) Pub Date : 2024-04-09 Elisabeth Höld, Sabine Chmelar, Tatjana Aubram, Gabriele Leitner, Stefan Nehrer, Oliver Neubauer, Karl-Heinz Wagner, Barbara Wondrasch
Osteoarthritis (OA) has long been considered as a degenerative disease of cartilage tissue resulting from bodily wear and tear. However, there is accumulating evidence that inflammation plays a key role in the pathogenesis of OA. In knee OA, the most common form of OA, exercise therapy as an effective component of early treatment addresses functional deficits, pain and inflammation. Since inflammation
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Clinical effects of atorvastatin combined with conbercept in the treatment of patients with macular edema secondary to retinal vein occlusion and carotid plaque: study protocol for a prospective randomized controlled trial Trials (IF 2.5) Pub Date : 2024-04-08 Bangtao Yao, Bei Wang, Jun Yang, Yan Geng, Hao Yu, Yuhui Liu, Gang Liu, Xiuying Wang
Intravitreal injections of anti-vascular endothelial growth factor (anti-VEGF) drugs have been widely used in patients with macular edema (ME) secondary to retinal vein occlusion (RVO); however, recurrence is a major concern. This study aims to observe the clinical effects of atorvastatin and intravitreal therapy in the treatment of patients with branch or central RVO-ME and coexistent carotid plaques
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A placebo-controlled, crossover trial to investigate the efficacy of tiotropium bromide or placebo added to usual care in stable symptomatic post-hematopoietic stem cell transplantation (HSCT) bronchiolitis obliterans syndrome (BOS) Trials (IF 2.5) Pub Date : 2024-04-06 Naeemeh Dini, Amin Pastaki Khoshbin, Rasoul Aliannejad, Hooman Bakhshandeh, Katayoun Najafizadeh, Mahshid Mehdizadeh, Shahideh Amini
Despite the fundamental progress in hematopoietic stem cell transplant, this treatment is also associated with complications. Graft-versus-host disease is a possible complication of HSCT. Bronchiolitis obliterans syndrome (BOS) is the pulmonary form of this syndrome. Due to the high morbidity and mortality rate of BOS, various studies have been conducted in the field of drug therapy for this syndrome
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Effects of transcutaneous electrical nerve stimulation on pain, function, and descending inhibition in people with non-specific chronic low-back pain: a study protocol for a randomized crossover trial Trials (IF 2.5) Pub Date : 2024-04-06 Richard E. Liebano, Kathleen A. Sluka, Joshua Roy, Meghan Savinelli, Dana L. Dailey, Sean P. Riley
Low back pain (LBP) is a significant public health problem, is very prevalent, and is often characterized by the persistence of symptoms. Transcutaneous electrical nerve stimulation (TENS) may benefit people with chronic LBP because it can activate descending inhibitory pathways and inhibit central excitability. However, previous studies that have investigated the effects of TENS on pain in people
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Statistical analyses of ordinal outcomes in randomised controlled trials: a scoping review Trials (IF 2.5) Pub Date : 2024-04-06 Chris J. Selman, Katherine J. Lee, Kristin N. Ferguson, Clare L. Whitehead, Brett J. Manley, Robert K. Mahar
Randomised controlled trials (RCTs) aim to estimate the causal effect of one or more interventions relative to a control. One type of outcome that can be of interest in an RCT is an ordinal outcome, which is useful to answer clinical questions regarding complex and evolving patient states. The target parameter of interest for an ordinal outcome depends on the research question and the assumptions the
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The clinical trial activation process: a case study of an Italian public hospital Trials (IF 2.5) Pub Date : 2024-04-05 Carolina Pelazza, Marta Betti, Francesca Marengo, Annalisa Roveta, Antonio Maconi
In order to make the centers more attractive to trial sponsors, in recent years, some research institutions around the world have pursued projects to reorganize the pathway of trial activation, developing new organizational models to improve the activation process and reduce its times. This study aims at analyzing and reorganizing the start-up phase of trials conducted at the Research and Innovation
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The effects of telerehabilitation in adults with complex biventricular congenital heart conditions: protocol for a multi-centre, randomised controlled trial—CH-FIT Trials (IF 2.5) Pub Date : 2024-04-05 Gina Wood, Anna Scheer, Jelena Saundankar, Derek Tran, Rachael Cordina, Andrew Maiorana
Accumulated evidence suggests that exercise training exerts beneficial effects on people with congenital heart conditions. These findings are predominantly derived from small, single-centre exercise trials conducted in outpatient rehabilitation facilities. In recent years, the delivery of exercise interventions remotely has increased through digital communications technology (telerehabilitation). However
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Effect of prebiotic oligosaccharides on bowel habit and the gut microbiota in children with functional constipation (Inside study): study protocol for a randomised, placebo-controlled, multi-centre trial Trials (IF 2.5) Pub Date : 2024-04-05 Carrie A. M. Wegh, Margriet H. C. Schoterman, Elaine E. Vaughan, Sofie C. C. van der Zalm, Hauke Smidt, Clara Belzer, Marc A. Benninga
Functional constipation (FC) in children is a common gastrointestinal disorder with a worldwide-pooled prevalence of 9.5%. Complaints include infrequent bowel movements, painful defecation due to hard and/or large stools, faecal incontinence, and abdominal pain. Prebiotic oligosaccharides have been shown to relieve constipation symptoms in young adults and elderly. However, sufficient evidence is lacking
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Does the use of higher versus lower oxygen concentration improve neurodevelopmental outcomes at 18–24 months in very low birthweight infants? Trials (IF 2.5) Pub Date : 2024-04-04 Georg M. Schmölzer, Elizabeth V. Asztalos, Marc Beltempo, Hector Boix, Eugene Dempsey, Walid El-Naggar, Neil N. Finer, Jo-Anna Hudson, Amit Mukerji, Brenda H. Y. Law, Maryna Yaskina, Prakesh S. Shah, Ayman Sheta, Amuchou Soraisham, William Tarnow-Mordi, Max Vento
Immediately after birth, the oxygen saturation is between 30 and 50%, which then increases to 85–95% within the first 10 min. Over the last 10 years, recommendations regarding the ideal level of the initial fraction of inspired oxygen (FiO2) for resuscitation in preterm infants have changed from 1.0, to room air to low levels of oxygen (< 0.3), up to moderate concentrations (0.3–0.65). This leaves
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Alternative consent methods used in the multinational, pragmatic, randomised clinical trial SafeBoosC-III Trials (IF 2.5) Pub Date : 2024-04-04 Maria Linander Vestager, Mathias Lühr Hansen, Gorm Greisen
The process of obtaining prior informed consent for experimental treatment does not fit well into the clinical reality of acute and intensive care. The therapeutic window of interventions is often short, which may reduce the validity of the consent and the rate of enrolled participants, to delay trial completion and reduce the external validity of the results. Deferred consent and ‘opt-out’ are alternative
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ROBot-assisted physical training of older patients during acUte hospitaliSaTion—study protocol for a randomised controlled trial (ROBUST) Trials (IF 2.5) Pub Date : 2024-04-04 Ann Sophia Bertelsen, Tahir Masud, Charlotte Suetta, Lisbeth Rosenbek Minet, Stig Andersen, Jørgen T. Lauridsen, Jesper Ryg
During hospitalisation, older patients spend most of their time passive in bed, which increases the risk of functional decline and negative adverse outcomes. Our aim is to examine the impact of robot-assisted physical training on functional status in older geriatric patients during acute hospitalisation. This is a single-centre investigator-blinded placebo-controlled randomised controlled trial including
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Increasing access to mental health supports for 12–17-year-old Indigenous youth with the JoyPop mobile mental health app: study protocol for a randomized controlled trial Trials (IF 2.5) Pub Date : 2024-04-04 Aislin R. Mushquash, Teagan Neufeld, Ishaq Malik, Elaine Toombs, Janine V. Olthuis, Fred Schmidt, Crystal Dunning, Kristine Stasiuk, Tina Bobinski, Arto Ohinmaa, Amanda Newton, Sherry H. Stewart
Indigenous youth in Northwestern Ontario who need mental health supports experience longer waits than non-Indigenous youth within the region and when compared to youth in urban areas. Limited access and extended waits can exacerbate symptoms, prolong distress, and increase risk for adverse outcomes. Innovative approaches are urgently needed to provide support for Indigenous youth in Northwestern Ontario
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Correction: Effect of an entry-to-care intervention on diabetes distress in individuals with newly diagnosed type 2 diabetes: a study protocol for a cluster-randomized trial Trials (IF 2.5) Pub Date : 2024-04-04 Steffan Holst Hansen, Troels Mygind Jensen, Gitte Stentebjerg Petersen, Francois Pouwer, Anders Larrabee Sonderlund, Jens Søndergaard
Correction: Trials 25, 207 (2024) https://doi.org/10.1186/s13063-024-07949-6 Following publication of the original article [1], we have been notified that the name of the 5th author was incorrectly spelled. Additionally, his part of his last name was tagged as first name. Originally spelled name: Anders L. Sønderlund Correct spelling of the name: Anders Larrabee Sonderlund The original article has
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Efficacy of supervised immersive virtual reality-based training for the treatment of chronic fatigue in post-COVID syndrome: study protocol for a double-blind randomized controlled trial (IFATICO Trial) Trials (IF 2.5) Pub Date : 2024-04-03 Jonas Tesarz, Hannah Lange, Marietta Kirchner, Axel Görlach, Wolfgang Eich, Hans-Christoph Friederich
The treatment of persistent fatigue after COVID-19 infection is complex. On the one hand, it involves maintaining a sufficient level of physical and mental activity to counteract possible degenerative processes of the body and nervous system. On the other hand, physical and mental activities can also lead to worsening of symptoms. Therefore, the challenge in treating Post-COVID fatigue is to stimulate
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Effectiveness of WeChat-assisted preoperative education to reduce perioperative anxiety in breast cancer patients: a prospective randomized controlled study protocol Trials (IF 2.5) Pub Date : 2024-04-03 Xiao Xiao, Yi-Ding Zuo, Shu-Yu Kuang, Chun-Yuan Liu, Kun-Shao, Heng Wang, Si-Yu Yan, Feng Yu, Yan Xu, Li Zhou, Chun-Ling Jiang
Breast cancer is the most prevalent cancer among women globally, and surgical procedures continue to be the primary treatment. However, over 50% of patients experience preoperative anxiety due to the unknown and fear associated with surgery. Although drug therapy is commonly used to address this anxiety, its side effects have led to a heated debate regarding its effectiveness. Consequently, non-pharmacological
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5-EPIFAT trial protocol: a multi-center, randomized, placebo-controlled trial of the efficacy of pharmacotherapy for fatigue using methylphenidate, bupropion, ginseng, and amantadine in advanced cancer patients on active treatment Trials (IF 2.5) Pub Date : 2024-04-03 Mojtaba Miladinia, Mina Jahangiri, Sharon Jackson White, Hossein Karimpourian, Alessandro Inno, Sally Wai-Chi Chan, Reza Ganji, Mahmood Maniati, Kourosh Zarea, Marziyeh Ghalamkari, Ali Farahat, Cecilia Fagerström
Cancer-related fatigue (CRF) is still undertreated in most patients, as evidence for pharmacological treatments is limited and conflicting. Also, the efficacy of the pharmacological agents relative to each other is still unclear. Therefore, medications that may potentially contribute to improving CRF will be investigated in this head-to-head trial. Our main objective is to compare the efficacy of methylphenidate
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Prednisolone Versus Colchicine for Acute Gout in Primary Care: statistical analysis plan for the pragmatic, multicenter, randomized, and double-blinded COPAGO non-inferiority trial Trials (IF 2.5) Pub Date : 2024-04-03 Adrian Richter, Julia Truthmann, Eva Hummers, Julia Freyer Martins Pereira, Ildikó Gágyor, Franziska Schuster, Amelie Witte, Susanne Böhm, Alexandra Greser, Petra Kamin, Sylvia Stracke, Marcus Dörr, Robin Bülow, Stefan Engeli, Jean François Chenot, Till Ittermann
To date, colchicine and prednisolone are two effective therapies for the treatment of acute gout but have never been compared directly in a randomized clinical trial. In addition, in previous trials of treating acute gout patients with concomitant comorbidities were often excluded due to contraindications to naproxen. This pragmatic, prospective, double-blind, double-dummy, parallel-group, randomized
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Study protocol for a pragmatic randomised controlled trial of comparing enhanced acceptance and commitment therapy plus (+) added to usual aftercare versus usual aftercare only, in patients living with or beyond cancer: SUrvivors’ Rehabilitation Evaluation after CANcer (SURECAN) trial Trials (IF 2.5) Pub Date : 2024-04-02 Imran Khan, Stephanie J. C. Taylor, Clare Robinson, Elisavet Moschopoulou, Paul McCrone, Liam Bourke, Mohamed Thaha, Kamaldeep Bhui, Derek Rosario, Damien Ridge, Sheila Donovan, Ania Korszun, Paul Little, Adrienne Morgan, Olivier Quentin, Rebecca Roylance, Peter White, Trudie Chalder
Two million people in the UK are living with or beyond cancer and a third of them report poor quality of life (QoL) due to problems such as fatigue, fear of cancer recurrence, and concerns about returning to work. We aimed to develop and evaluate an intervention based on acceptance and commitment therapy (ACT), suited to address the concerns of cancer survivors and in improving their QoL. We also recognise
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A pragmatic randomized controlled trial to evaluate the efficacy and safety of an oral short-course regimen including bedaquiline for the treatment of patients with multidrug-resistant tuberculosis in China: study protocol for PROSPECT Trials (IF 2.5) Pub Date : 2024-04-01 Jingtao Gao, Mengqiu Gao, Jian Du, Yu Pang, Gary Mao, Nacer Lounis, Nyasha Bakare, Yanxin Jiang, Ying Zhan, Yuhong Liu, Liang Li
The lack of safe, effective, and simple short-course regimens (SCRs) for multidrug-resistant/rifampicin-resistant tuberculosis (MDR/RR-TB) treatment has significantly impeded TB control efforts in China. This phase 4, randomized, open-label, controlled, non-inferiority trial aims to assess the efficacy and safety of a 9-month all-oral SCR containing bedaquiline (BDQ) versus an all-oral SCR without
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A single-center, open-labeled, randomized, 6-month, parallel-group study to assess the safety and efficacy of allogeneic cultured keratinocyte sheet transplantation for deep second-degree burn wounds: rationale and design of phase I/II clinical trial Trials (IF 2.5) Pub Date : 2024-04-01 Shayan Farzanbakhsh, Mohammad Amin Shahrbaf, Hoda Madani, Mostafa Dahmardei, Bahareh Sadri, Massoud Vosough
Burn-related injuries are a major global health issue, causing 180,000 deaths per year. Early debridement of necrotic tissue in association with a split-thickness skin graft is usually administered for some of the 2nd- and 3rd-degree injuries. However, this approach can be complicated by factors such as a lack of proper donor sites. Artificial skin substitutes have attracted much attention for burn-related
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Design and evaluation of mobile application for adolescents’ self-care: protocol for a randomized controlled field trial Trials (IF 2.5) Pub Date : 2024-03-28 Razieh Rezaee, Mohtasham Ghaffari, Reza Rabiei, Amir Kavousi, Sakineh Rakhshanderou
Adolescence is a critical stage for the development of self-care. Many adolescents use mobile apps to monitor and improve their health. Health information technology plays a significant role in the field of self-care. This article provides a protocol for a study to design and evaluate mobile applications for adolescent self-care. The present research is a combination of applied development study, methodological
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Current usage of explainer animations in trials: a survey of the UKCRC registered clinical trial units in the UK Trials (IF 2.5) Pub Date : 2024-03-28 Vicki S. Barber, Clare Calvert, Duncan Appelbe, Kirsty Sprange, Claire Nollett, Samantha Tanner, Duncan B. Richards
Explainer animations are a means to communicate aspects of clinical trials to participants in a more engaging and accessible way. Delivered well these have the potential to enhance recruitment and retention. The range of media technology used to deliver this material is expanding rapidly but is highly fragmented. Usage of explainer animations across the UK is unknown, the aim of this research was to
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Study protocol for a prospective, randomized, multicenter trial to investigate the influence of peripheral nerve stimulation on patients with chronic sacroiliac joint syndrome (SILENCING) Trials (IF 2.5) Pub Date : 2024-03-28 Tarik Alp Sargut, Dimitri Tkatschenko, Anton Früh, Jochen Tüttenberg, Alexander Heckert, Steffen Fleck, Anja Kuckuck, Simon Heinrich Bayerl
The prevalence of sacroiliac joint pain (SIJP) is estimated to be 10–30% in patients with chronic low back pain. Numerous conservative and surgical treatment modalities for SIJP have been described with limited evidence regarding long-term pain relief. Spinal cord stimulation (SCS) is a well-established technique to treat patients with chronic low back pain. However, the effect on patients with SIJP
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Individual Placement and Support for persons with alcohol and drug addiction in a Swedish context (IPS-ADAS): study protocol for a randomised controlled trial Trials (IF 2.5) Pub Date : 2024-03-27 Ulrika Bejerholm, Anders Håkansson, Marcus Knutagård, Helene Hillborg
Employment is a vital source for experiencing well-being and lowering the risk of long-term social marginalisation and poverty. For persons with alcohol and drug addiction, it may also improve sobriety. However, the unemployment situation for this group reflects the knowledge gap in effective interventions to support employment. While Individual Placement and Support (IPS) is recognised as evidence-based
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The REPAIR study: oral antibiotics to prevent infection and wound dehiscence after obstetric perineal tear—a double-blinded placebo controlled randomized trial Trials (IF 2.5) Pub Date : 2024-03-27 Kathrine Perslev, Niels Klarskov, Thomas Bergholt, Hanna Jangö
Approximately 85% of women experience an obstetric tear at delivery and up to 25% subsequently experience wound dehiscence and/or infection. Previous publications suggest that intravenous antibiotics administrated during delivery reduces this risk. We do not know if oral antibiotics given after delivery can reduce the risk of wound dehiscence or infection. Our aim is to investigate whether three doses
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Cost-effectiveness and cost-utility of the ball-and-socket trapeziometacarpal prosthesis compared to trapeziectomy and ligament reconstruction: study protocol for a randomized controlled clinical trial Trials (IF 2.5) Pub Date : 2024-03-27 Serafín Lirola-Palmero, Guillem Salva-Coll, Aina María Yáñez-Juan, Eduardo Sánchez-Iriso
Trapeziometacarpal (TMC) osteoarthritis (OA) is a common cause of pain and weakness during thumb pinch leading to disability. There is no consensus about the best surgical treatment in unresponsive cases. The treatment is associated with costs and the recovery may take up to 1 year after surgery depending on the procedure. No randomized controlled trials have been conducted comparing ball and socket
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Optimization of cardiopulmonary bypass prime fluid to preserve microcirculatory perfusion during on-pump coronary artery bypass graft surgery: PRIME study protocol for a double-blind randomized trial Trials (IF 2.5) Pub Date : 2024-03-26 Anne M. Beukers, Carolien S. E. Bulte, Ruben J. Bosch, Susanne Eberl, Charissa E. van den Brom, Stephan A. Loer, Alexander B. A. Vonk
Acute microcirculatory perfusion disturbances and organ edema are important factors leading to organ dysfunction during cardiac surgery with cardiopulmonary bypass (CPB). Priming of the CPB system with crystalloid or colloid fluids, which inevitably leads to hemodilution, could contribute to this effect. However, there is yet no optimal evidence-based strategy for this type of priming. Hence, we will
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Clinical statistical analysis plan for the ACCURE trial: the effect of appendectomy on the clinical course of ulcerative colitis, a randomised international multicentre trial Trials (IF 2.5) Pub Date : 2024-03-26 Eva Visser, Lianne Heuthorst, Shri Pathmakanthan, Willem A. Bemelman, Geert R. D’Haens, Kelly Handley, Apostolos Fakis, Thomas D. Pinkney, Christianne J. Buskens, Marcel G. W. Dijkgraaf
The primary treatment of ulcerative colitis (UC) is medical therapy using a standard step-up approach. An appendectomy might modulate the clinical course of UC, decreasing the incidence of relapses and reducing need for medication. The objective of the ACCURE trial is to assess the efficacy of laparoscopic appendectomy in addition to standard medical treatment in maintaining remission in UC patients