Persistence of gastrointestinal symptoms in irritable bowel syndrome and ulcerative colitis: study protocol for a three-arm randomised controlled trial (SOMA.GUT-RCT) by Ansgar W Lohse, Bernd Löwe, Kerstin Maehder, Yvonne Nestoriuc, Antonia Zapf, Eik Vettorazzi, Viola Andresen, Sina Hübener, Luisa Peters

“…Our primary hypothesis is that persistent gastrointestinal symptoms in UC and IBS can be improved by modifying dysfunctional symptom expectations and illness-related anxiety using expectation management strategies.Methods and analysis To assess the extent to which persistent somatic symptoms are modifiable in adult patients with UC and IBS, we will conduct an observer-blinded, three-arm randomised controlled trial. A total of 117 patients with UC and 117 patients with IBS will be randomised into three groups of equal size: targeted expectation management aiming to reduce illness-related anxiety and dysfunctional symptom expectations in addition to standard care (SC, intervention 1), non-specific supportive treatment in addition to SC (intervention 2) or SC only (control). …”
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Two Transcutaneous Stimulation Techniques in Shoulder Pain: Transcutaneous Pulsed Radiofrequency (TPRF) versus Transcutaneous Electrical Nerve Stimulation (TENS): A Comparative Pil... by Mu-Lien Lin, Hung-Wei Chiu, Zao-Ming Shih, Po-Ying Lee, Pei-Zhi Li, Chin-Hong Guo, Yuan-Jie Luo, Shen-Chieh Lin, Kwan-Yu Lin, Yu-Ming Hsu, Angela Pang, Weiwu Pang

“…A prospective, randomized, and double-blind clinical trial. Setting. Academic pain service of a city hospital. …”
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WALLABY Pilot Survey: Star Formation Enhancement and Suppression in Gas-rich Galaxy Pairs by Qifeng Huang, Jing Wang, Xuchen Lin, Se-Heon Oh, Xinkai Chen, B. Catinella, N. Deg, H. Dénes, B. -Q. For, B. S. Koribalski, K. Lee-Waddell, J. Rhee, A. X. Shen, Li Shao, K. Spekkens, L. Staveley-Smith, T. Westmeier, O. I. Wong, A. Bosma

“…Here, we investigate the SFR enhancement of gas-rich galaxy pairs detected by the Widefield ASKAP L -band Legacy All-sky Blind surveY. We construct a sample of 278 paired galaxies spanning a stellar mass ( M _* ) range from 10 ^7.6 to 10 ^11.2 M _⊙ . …”
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Low-Frequency Repetitive Transcranial Magnetic Stimulation over Right Dorsolateral Prefrontal Cortex in Parkinson’s Disease by Sheng Zhuang, Fu-Yu Wang, Xin Gu, Jia-Jing Wu, Cheng-Jie Mao, Hao Gui, Jing Chen, Chun-Feng Liu

“…We conducted a randomized, single-blind, sham-controlled parallel trial to compare the effect of 10 consecutive daily sessions of 1 Hz rTMS over right DLPFC on individuals with idiopathic PD between active and sham rTMS group. …”
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A legume-enriched diet improves metabolic health in prediabetes mediated through gut microbiome: a randomized controlled trial by Xiaorong Wu, Alvin Surya Tjahyo, Vera Sergeyevna Brok Volchanskaya, Long Hui Wong, Xianning Lai, Yi Ning Yong, Farhana Osman, Shia Lyn Tay, Priya Govindharajulu, Shalini Ponnalagu, Rachel Tso, Hwee Sze Teo, Kaijie Khoo, Huan Fan, Chew Chan Goh, Clara Poh Lian Yap, Melvin Khee-Shing Leow, Christiani Jeyakumar Henry, Sumanto Haldar, Kevin Junliang Lim

“…The study was a 16-week, single-blind, parallel-design, randomized controlled trial (n = 63 intervention group (IG), n = 64 control group (CG); mean ± SD age 62.2 ± 6.3 years, BMI 23.8 ± 2.6 kg/m2). …”
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Assessing patient risk, benefit and outcomes in drug development: an observational study of regorafenib clinical trials by Matt Vassar, Vinay Prasad, Ryan McIntire, Alyson Haslam, Brody Dennis, Chance Bratten, Griffin K Hughes, Andriana M Peña, Chase Ladd, Brooke Gardner, William Nowlin, Reagan Livingston, Jordan Tuia

“…Most studies (44 of 56; 78.75%) were non-blinded, and a majority were non-randomised (41 of 56; 73.21%). …”
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Auricular acupressure for minimizing adverse reactions to colonoscopic bowel preparation in hospitalized patients: A randomized controlled trial by Jiahui Zhang, Chang Liu, Guodong Ruan, Haiyan Zhang, Beiping Zhang, Xuejun Hu, Cailing Zhong

“…Methods: This was a prospective, assessor-blinded, randomized controlled clinical trial implemented at Guangdong Provincial Hospital of Chinese Medicine. …”
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Effects of biophilic virtual reality on cognitive function of patients undergoing laparoscopic surgery: study protocol for a sham randomised controlled trial by Bin Gao, Yanling Zhou, Jianhua Wang, Binbin Zhu, Qiuyan Weng, Wenjun Luo, Xiuchao He, Lufei Jin, Qinwen Wang, Ahmad Khaled Ahmad Harb

“…Due to the lack of an effective postoperative follow-up system, the incidence of POCD in China is not clear, and although many drugs have been proposed to improve POCD in the animal study, their clinical applications are limited, while VR provides an innovative method to provide non-pharmacological management.Methods and design This is a single-centre, randomised, double-blind, sham-controlled clinical trial. In this study, 600 patients over 55 years old undergoing laparoscopic surgery will be recruited. …”
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Lysozyme-based spray for treatment of radiotherapy-induced oral mucositis by Zdenka Gojković, Jelena Rožić, Nataša Gašpar, Aziz Šukalo, Meliha Mehić, Amna Tanović Avdić, Una Glamočlija

“…However, a larger randomized, blinded study is needed to confirm our results [the study was registered at the Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina (https://klinicka.almbih.gov.ba/pages/klinicka-registar-javni) under the protocol number LCS-OM-01].…”
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Multicentre, prospective, randomised controlled trial to evaluate hexaminolevulinate photodynamic therapy (Cevira) as a novel treatment in patients with high-grade squamous intraep... by Fei Chen, Jinghe Lang, Peter Hillemanns, Youzhong Zhang, Zoltán Novák, Long Sui, Ling Han, Christian Dannecker, Ctirad Mokráš, Zhixue You

“…APRICITY is a multicentre, prospective, double-blind, randomised controlled phase 3 study further evaluating the efficacy and safety of Cevira, an integrated drug-delivery and light-delivery device for hexaminolevulinate photodynamic therapy, which shows promise as a novel, non-invasive outpatient therapy for women with HSIL.Methods and analysis Patients with biopsy-confirmed HSIL histology are invited to participate in the study planned to be conducted at 47 sites in China and 25 sites in Ukraine, Russia and the European Union. …”
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Acute Severe Anaphylaxis in Nepali Patients with Neurotoxic Snakebite Envenoming Treated with the VINS Polyvalent Antivenom by Sanjib Kumar Sharma, Emilie Alirol, Anup Ghimire, Suman Shrestha, Rupesh Jha, Surya B. Parajuli, Deekshya Shrestha, Surya Jyoti Shrestha, Amir Bista, David Warrell, Ulrich Kuch, Francois Chappuis, Walter Robert John Taylor

“…Patients were enrolled in a randomised, double-blind trial of high vs. low dose antivenom, given by intravenous (IV) push, followed by infusion. …”
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Alpha-2-adrenergic receptor agonists for the prevention of delirium and cognitive decline after open heart surgery (ALPHA2PREVENT): protocol for a multicentre randomised controlled... by Eva Skovlund, Rune Haaverstad, Henrik Zetterberg, Jorunn L Helbostad, Rolf Busund, Johan Raeder, Theis Tønnessen, Torgeir Bruun Wyller, Melanie R Simpson, Nils Kristian Skjærvold, Bjørn Erik Neerland, Svein Aslak Landsverk, Ieva Martinaityte, Hilde Margrethe Norum, Geir Selbaek, Elisabeth Skaar, Arjen JC Slooter, Øyvind Sverre Svendsen, Alexander Wahba

“…We aim to study whether repurposing of clonidine can represent a novel treatment option for delirium, and the possible effects of dexmedetomidine and clonidine on long-term cognitive trajectories, motor activity patterns and biomarkers of neuronal injury, and whether these effects are associated with frailty status.Methods and analysis This five-centre, double-blind randomised controlled trial will include 900 cardiac surgery patients aged 70+ years. …”
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Electrocardiographic Changes in Pregnant Patients With Congenital Heart Disease by Maria A. Pabon, Amrit Misra, Kimberlee Gauvreau, Madeline E. Duncan, Ava Conklin, Katherine E. Economy, Fred M. Wu, Thomas Tadros, Anne Marie Valente, For the STORCC Investigators

“…EKG parameters were measured in all available EKGs by two investigators, blinded to diagnosis and time of gestation. Results One hundred and seventy pregnant patients were included. …”
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OMERACT GCA phantom project: validation of a 3D-printed ultrasound training phantom for diagnosis of giant cell arteritis by Annamaria Iagnocco, Christian Dejaco, Richard J Wakefield, Stavros Chrysidis, Sara Monti, Thomas Daikeler, Esperanza Naredo, Lene Terslev, Wolfgang A Schmidt, Alojzija Hočevar, Christina Duftner, Chetan Mukhtyar, Valentin Sebastian Schäfer, Kate Smith, Eugenio De Miguel, Marcin Milchert, Andreas P Diamantopoulos, Pierluigi Macchioni, Uffe Møller Døhn, George A Bruyn, Verena Tischler, Wolfgang Hartung, Markus Aschwanden, Giuseppe Germanò, Aaron Juche, Rositsa Karalilova, Dennis Boumans, Kresten Krarup Keller, Luca Seitz, Berit Nielsen, Tobias Schremmer, Florian Recker, Cees Haagsma, Pantelis Karakostas, Borsha Sarker

“…This study tested the reliability of ultrasonography findings and measurements of the intima-media thickness (IMT) among ultrasonography experts by using phantoms of the axillary (AA) and temporal arteries (TA) created with high-resolution 3D printing.Methods Twenty-eight participants from 12 European countries received eight sets of phantoms of the AA and the superficial TA (including common, frontal and parietal branches), which were examined in a blinded fashion according to a predefined protocol and evaluated based on Outcome Measures in Rheumatology (OMERACT) GCA ultrasound definitions. …”
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Phase 1 study of safety, tolerability, and efficacy of intradermal DNA vaccine ASP2390 in adults allergic to house dust mites by Thomas Kayser, MD, BS, Ronald Smulders, MD, PhD, Tomohiro Kusawake, PhD, Erik Wambre, PhD, Gurunadh R. Chichili, PhD, Mary B. Blauwet, DrPH, Anna Spence, MS, Melanie Patton, BS, Rima Tabash, PhD, Hannah A. DeBerg, PhD, Sugandhika Khosa, MS, Philipp Badorrek, MD, Jens M. Hohlfeld, MD, Brian C. Ferslew, PharmD, PhD

“…Methods: A randomized, double-blind, placebo-controlled phase 1 trial was conducted in adults with HDM-induced allergic rhinitis. …”
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Short-term effects of empagliflozin on preventing contrast induced acute kidney injury in patients undergoing percutaneous coronary intervention, a randomised trial by Zeinab Sadat Hosseini, Mohammad Javad Jamili, Behzad Ensan, Ghazaleh Donyadideh, Bahram Shahri, Hamid Eshraghi, Susan Darroudi, Mohsen Moohebati

“…This research conducted a double-blind randomized clinical trial involving 121 patients undergoing PCI referred to Ghaem Hospital, Mashhad, Iran from 2022 to 2023. …”
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mHealth Intervention for Dementia Prevention through lifestyle Optimisation (MIND-PRO) in a primary care setting: protocol for a randomised controlled trial in people with low SES... by Edo Richard, Esther Van den Berg, Ron Handels, Henrike Galenkamp, Eric P Moll van Charante, Marieke P Hoevenaar-blom, Anne Roos van der Endt, Martien J H Kas

“…The study aims to evaluate the effectiveness and implementation of an mHealth intervention designed for self-managing lifestyle modifications with remote coaching to reduce dementia risk factors.Methods and analysis This prospective randomised open-label blinded end point (PROBE) trial follows a type 2 hybrid effectiveness-implementation design with a 12-month intervention period. …”
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Accelerated symptom improvement in Parkinson’s disease via remote internet-based optimization of deep brain stimulation therapy: a randomized controlled multicenter trial by Alireza Gharabaghi, Sergiu Groppa, Marta Navas-Garcia, Alfons Schnitzler, Laura Muñoz-Delgado, Vicky L. Marshall, Jessica Karl, Lin Zhang, Ramiro Alvarez, Mary S. Feldman, Michael J. Soileau, Lan Luo, S. Elizabeth Zauber, Benjamin L. Walter, Chengyuan Wu, Hong Lei, Damian M. Herz, Ming-Hua Chung, Yagna Pathak, Bram Blomme, Binith Cheeran, Corneliu Luca, Daniel Weiss

“…Patients, caregivers, and outcome assessors were not blinded to group assignment. Most of the data collection took place in the patient’s home environment. …”
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Cognitive improvement and prefrontal network interactions in individuals with remitted bipolar disorder after transcranial infrared laser stimulation by Douglas W. Barrett, Roger E. Davis, Jennifer E. Siegel-Ramsay, Amy Bichlmeier, Jorge R. C. Almeida, F. Gonzalez-Lima

“…To confirm TILS efficacy, a sham-controlled, double-blinded randomized trial is needed.Clinical trial registrationhttps://clinicaltrials.gov/, identifier NCT05354895.…”
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Oral cannabidiol did not impair learning and memory in healthy adults by Hanna H. Gebregzi, Joanna S. Zeiger, Jeffrey P. Smith, Libby Stuyt, Luann Cullen, Jim Carsella, Daniel C. Rogers, Jordan Lafebre, Jennah Knalfec, Alfredo Vargas, Moussa M. Diawara

“…Method A two-arm crossover, randomized, double-blind, placebo-controlled trial was conducted at Colorado State University Pueblo (CSU Pueblo) to evaluate the effects of 246 mg oral CBD on L&M in healthy adults. …”
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