Multicentre, 26-week, open-label phase 2 trial of the JAK inhibitor filgotinib in Behçet’s disease, idiopathic inflammatory myopathies and IgG4-related disease: DRIMID study protoc... by Sander W Tas, Joost Raaphorst, Paco M J Welsing, Jacob M van Laar, Rogier M Thurlings, Robbert J Goekoop, César Magro Checa, Jan A M van Laar, Bettina C Geertsema-Hoeve, Nicolle H Rekers, Erik Present

“…An interim analysis is conducted between these stages, where the trial will proceed only in diseases showing potential effectiveness. …”
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An automatic fermentation nutrition system compared to a traditional one: fermentation performances and composition of white wines by Matteo, Clara Vitaggio, Fabrizio Ghinolfi, Filippo Amato, Luciano Cinquanta, Onofrio Corona

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A Comparative Study between Conventional Diaphragmatic Breathing Exercise and Virtual Reality-based Diaphragmatic Breathing Exercise on Quality of Life in Chronic Obstructive Pulmo... by Sridhar Shirodkar, Medha Deo

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Patients’ acceptability and implementation outcomes of a case management approach to encourage participation in colorectal cancer screening for people with schizophrenia: a qualita... by Tempei Miyaji, Yosuke Uchitomi, Hiroyuki Okada, Masatoshi Inagaki, Maiko Fujimori, Taichi Shimazu, Masaki Fujiwara, Masafumi Kodama, Ryuhei So, Takanori Matsushita, Yusaku Yoshimura, Shigeo Horii, Hirokazu Takahashi, Naoki Nakaya, Shiro Hinotsu, Keita Harada, Norihito Yamada, Yuto Yamada, Tsuyoshi Etoh

“…However, providing the intervention to all patients simultaneously was considered difficult with the current human resources.Conclusions This study showed that the CM intervention was perceived as acceptable by patients and acceptable and appropriate by psychiatric care providers.Trial registration number UMIN000036017.…”
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Effectiveness of a Web-Based Self-Guided Intervention (MINDxYOU) for Reducing Stress and Promoting Mental Health Among Health Professionals: Results From a Stepped-Wedge Cluster Ra... by Yolanda López-del-Hoyo, Selene Fernández-Martínez, Adrian Perez-Aranda, Alicia Monreal-Bartolomé, Alberto Barceló-Soler, Loreto Camarero-Grados, Carilene Armas-Landaeta, José Guzmán-Parra, Vera Carbonell, Daniel Campos, Xinyuan Chen, Javier García-Campayo

“…Finding ways to promote adherence to the intervention would contribute to increasing the effectiveness of this program. Trial RegistrationClinicalTrials.gov NCT05436717; https://clinicaltrials.gov/study/NCT05436717 International Registered Report Identifier (IRRID)RR2-10.1186/s12912-022-01089-5…”
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Efficacy and safety of an algorithm using C-reactive protein to guide antibiotic therapy applied through a digital clinical decision support system: a study protocol for a randomis... by Vandack Nobre, Pedro R Povoa, Vitoria Moura Leite Rabelo Rezende, Isabela Nascimento Borges, Cecilia Gomez Ravetti, Renan Pedra De Souza, Paula Frizera Vassalo, Ana Clara de Paula Caldas, Felipe Rodrigues Gatto, Getulio Hideyoshi Okamura, Raquel Lopes de Brito Lacerda

“…Access will be controlled via credentials, with privacy protections and anonymisation prior to sharing, which will occur during scientific publications.Trial registration number This trial was registered on ClinicalTrials.gov (NCT05841875) and was last updated on 5 December 2024 at 12:49.…”
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Economic evaluation of encorafenib with cetuximab in patients with BRAF V600E-mutant metastatic colorectal cancer in France: a cost-effectiveness analysis using data from the BEACO... by David Malka, Philippe Laramée, Mondher Toumi, Jean-Baptiste Trouiller, Bérengère Macabeo, Andrew Poll, Dan Howard, Andy Buckland, Marine Sivignon, Emilie Clay, Emmanuelle Samalin

“…Objective The BEACON CRC randomised controlled trial (NCT02928224) in BRAF-mutant metastatic colorectal cancer (mCRC) patients showed improved overall survival for the combination treatment of encorafenib (BRAF inhibitor) with cetuximab (EGFR inhibitor) compared with cetuximab with chemotherapy (FOLFIRI (folinic acid, fluorouracil and irinotecan) or irinotecan). …”
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Cardio-renal effect of dapagliflozin and dapagliflozin- saxagliptin combination on CD34 + ve hematopoietic stem cells (HSCs) and podocyte specific markers in type 2 diabetes (T2DM)... by Seshagiri Rao Nandula, Arad Jain, Sabyasachi Sen

“…Trial Registration The trial was registered with Clinical Trials.gov number NCT03660683, last updated 06052023.…”
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Acceptability, feasibility, and effectiveness of internet-based cognitive behavior therapy for obsessive–compulsive disorder (OCD-NET): a naturalistic pilot trial during the COVID-... by Elisabeth Kohls, Sabrina Baldofski, Julia Scholl, Oskar Flygare, Lina Lundström, Ursula Beyrich-Kolbus, Marc Steinbrecher, Christian Rück, Christine Rummel-Kluge

“…Methods In an open, naturalistic pilot trial, N = 57 patients with OCD received a 10-week ICBT program (called “OCD-NET”). …”
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Can the Onset of Type 2 Diabetes Be Delayed by a Group-Based Lifestyle Intervention in Women with Prediabetes following Gestational Diabetes Mellitus (GDM)? Findings from a Randomi... by Angela O’Dea, Marie Tierney, Brian E. McGuire, John Newell, Liam G. Glynn, Irene Gibson, Eoin Noctor, Andrii Danyliv, Susan B. Connolly, Fidelma P. Dunne

“…At one-year follow-up, the intervention group showed significant improvements over the wait control group on stress, diet self-efficacy, and quality of life. …”
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Anaesthetic Efficacy of 4% Articaine in Comparison with 2% Lidocaine as Intraligamentary Injections after an Ineffective Inferior Alveolar Nerve Block in Mandibular Molars with Irr... by Nazanin Zargar, Elnaz Shooshtari, Leila Pourmusavi, Alireza Akbarzadeh Baghban, Hengameh Ashraf, Ardavan Parhizkar

“…Statistical analysis was performed using repeated measures ANOVA, chi-square, and independent-sample and paired-sample t-tests. The results showed that there was no significant difference in the success rates of supplemental IL and IANB injections between articaine and lidocaine. …”
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Effectiveness and safety profile of mesenchymal stem cell secretome as a treatment for severe cases of COVID-19: a randomized controlled trial [version 2; peer review: 1 approved,... by Hary Sakti Muliawan, Erlina Burhan, Mia Elhidsi, Heri Wibowo, Triya Damayanti, Jeanne Adiwinata Pawitan, Isabella Kurnia Liem, Ismail Hadisoebroto Dilogo, Mira Yulianti, Adityo Susilo, Irandi Putra Pratomo, Raden Rara Diah Handayani, Rahyussalim -, Murdani Abdullah, Cosphiadi Irawan, Robert Sinto, Dita Aditianingsih

“…Methods: A double-blind, multicenter, randomized, placebo-controlled trial was conducted between February 2021 and July 2021 in three top COVID-19 referral hospitals in the Greater Jakarta area, Indonesia. …”
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Effectiveness of a universal film intervention in reducing violence against children and increasing positive parenting among migrant and displaced caregivers from Myanmar: a commun... by Amanda Sim, Khaing Zar Lwin, Stephanie Eagling-Peche, G.J. Melendez-Torres, Seema Vyas, Francisco Calderon, Tawanchai Jirapramukpitak, Jamie Lachman, Sureeporn Punpuing, Andrea Gonzalez, Mary Soan, Nway Nway Oo, Ivet Castello Mitjans, Greg Tyrosvoutis, Eve Puffer

“…Due to the nature of the intervention, participants and assessors were not masked. The trial was prospectively registered with Thai Clinical Trials Registry TCTR20230222005. …”
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Left Ventricular End-Diastolic Pressure and B-Type Natriuretic Peptide Levels Guidance of Low-Dose Furosemide Treatment to Prevent Contrast-Induced Nephropathy in Patients with Per... by Guoqiang Gu, Demin Liu, Rui Lu, Wei Cui

“…This parallel randomized clinical trial was conducted at a tertiary hospital in China. …”
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Comparison of surgical wound infection and dehiscence following the use of two methods of nylon sutures and skin staples in staples in diabetic mellitus patients undergoing total k... by Haadiyeh Rahbari, Mohammadamin Ahmadi, Mina Amiri Doreh, Samira Mahmoudi, Parvin Ghaemmaghami, Armin Fereidouni

“…IRCT20230928059543N1, Trial Id:74754, approved on 12/01/2024, https://irct.behdasht.gov.ir/user/trial/74754/view ) and conducted according to Consolidated Standards of Reporting Trials (CONSORT) guidelines.…”
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Comparison of the impact of intermittent fasting diet alone or in conjunction with probiotic supplementation versus calorie-restricted diet on inflammatory, oxidative stress, and a... by Sepide Talebi, Sakineh Shab-Bidar, Gholamreza Askari, Hamed Mohammadi, Ashraf Moini, Kurosh Djafarian

“…Total antioxidant capacity (TAC) also showed notable improvement in both the eTRE + probiotic group (P = 0.012) and the DCR group (P = 0.032). …”
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Cost-utility of behavioural activation for mitigating psychological impacts of COVID-19 on socially isolated older adults with depression and multiple long-term conditions compared... by Simon Gilbody, Caroline Fairhurst, Catherine Hewitt, Dean McMillan, Carolyn Chew-Graham, Della Bailey, David Ekers, Steve Parrott, Elizabeth Littlewood, Peter Coventry, Han-I Wang, Kalpita Baird

“…Behavioural activation (BA) shows promise as a remote intervention for depression during isolation, but its cost-effectiveness for depressed, socially isolated older adults remains uncertain.Objective This study aimed to assess the cost-utility of BA versus usual care for older adults with depression and MLTCs during COVID-19 restrictions.Methods A randomised controlled trial recruited and randomised individuals aged 65 and over with depressive symptoms and MLTC (n=435) to either the BA intervention or usual care. …”
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Transcutaneous spinal cord stimulation combined with robotic-assisted body weight-supported treadmill training enhances motor score and gait recovery in incomplete spinal cord inju... by Natalia Comino-Suárez, Juan C. Moreno, Álvaro Megía-García, Antonio J. del-Ama, Diego Serrano-Muñoz, Juan Avendaño-Coy, Ángel Gil-Agudo, Mónica Alcobendas-Maestro, Esther López-López, Julio Gómez-Soriano

“…Methods A randomized, double-blind, sham-controlled clinical trial was conducted. Twenty-seven subacute iSCI participants were randomly allocated to tSCS or sham-tSCS group. …”
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Comparing the Efficacy and Safety of Glucagon-Like Peptide 1 Receptor Agonists with Sodium-Glucose Cotransporter 2 Inhibitors for Obese Type 2 Diabetes Patients Uncontrolled on Met... by Lu Ding, Bang Sun, Xinhua Xiao

“…To conduct the first meta-analysis of randomized controlled trials (RCTs) comparing glucagon-like peptide 1 receptor agonists (GLP-1RAs) with sodium-glucose cotransporter 2 inhibitors (SGLT-2is) for obese type 2 diabetes (T2D) patients uncontrolled on metformin. …”
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Phase II randomised, double-blind, placebo-controlled trial to assess the efficacy and safety of MLC1501 in patients with stroke: the MLC1501 study Assessing Efficacy in post-STrOk... by Narayanaswamy Venketasubramanian, Deidre Anne De Silva, Christopher P L H Chen, Cyrus G Escabillas, John Harold Hiyadan, Johnny K Lokin, Romulo U Esagunde, Joel M Advincula, Christian Oliver C Co, Maria Epifania V Collantes, Annabelle Y Lao, Yeow-Hoay Koh, Carol Huilian Tham

“…The results of this study will provide objective level B evidence on the efficacy of MLC1501 on long-term recovery and safety of 24 weeks of treatment among patients with IS.Trial registration number NCT05289947.…”
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