Safety and Immunogenicity of the Tetravalent Recombinant COVID-19 Protein Vaccine SCTV01E in Children and Adolescents Aged 3 to 17 Years: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial by Fengcai Zhu, Ting Huang, Pengfei Jin, Linglin Zhang, Zhongqiang Jin, Wenli Zhang, Dongya Yuan, Zhong Wang, Yusong Deng, Jiaxin Li, Xiao Shen, Yongpan Fu, Jian Li, Xinjie Yang, Jing Li, Liangzhi Xie

“…<b>Objective</b>: This Phase 2 trial assessed the safety and immunogenicity of SCTV01E in healthy children and adolescents aged 3 to 17 years, to establish immunobridging with that observed in adults from the efficacy pivotal trial (NCT05308576). …”
Get full text

Post-kala-azar dermal leishmaniasis (PKDL) drug efficacy study landscape: A systematic scoping review of clinical trials and observational studies to assess the feasibility of establishing an individual participant-level data (IPD) platform. by Sauman Singh-Phulgenda, Rishikesh Kumar, Prabin Dahal, Abdalla Munir, Sumayyah Rashan, Rutuja Chhajed, Caitlin Naylor, Brittany J Maguire, Niyamat Ali Siddiqui, Eli Harriss, Manju Rahi, Fabiana Alves, Shyam Sundar, Kasia Stepniewska, Ahmed Musa, Philippe J Guerin, Krishna Pandey

“…Eight (14.3%) were randomised clinical trials, and 48 (85.7%) were non-randomised studies. …”
Get full text

Adherence and efficacy outcomes in young Australians with suicidal ideation using a self-management app and digital engagement strategy compared with a sham app: a three-arm randomised controlled trialResearch in context by Michelle Torok, Lauren McGillivray, Daniel Z.Q. Gan, Jin Han, Sarah Hetrick, Quincy J.J. Wong

“…All data was analysed using intention-to-treat. This trial was registered at anzctr.org.au, trial number: ACTRN12621001247864. …”
Get full text

A pilot randomized controlled study of integrated kidney palliative care and chronic kidney disease care implemented in a safety-net hospital: Protocol for a pilot study of feasibility of a randomized controlled trial by Jennifer S. Scherer, Wenbo Wu, Chen Lyu, Keith S. Goldfeld, Abraham A. Brody, Joshua Chodosh, David Charytan

“…Contemporary Clinical Trials Communications…”
Get full text

Efficacy and safety of NeoAdjuvant chemotherapy with or without tIslelizumab followed by debulking surgery for oVarian cancEr (NAIVE study) in China: study protocol of an open-label, phase II, randomised controlled trial by Ying Zhu, Jianwei Zhou, Zhigang Zhang, Jiaojiao Zhang, Jing Fei, Xiaoqing Zhu

“…Presentations at scientific and professional meetings and publication in peer-reviewed journals will disseminate the results of the study.Trial registration number NCT04815408.…”
Get full text

The effectiveness of exercise-based interventions on muscle mass, muscle strength, functional performance, aerobic capacity, and health-related quality of life in adults with malignant lymphoma undergoing chemotherapy: a systematic review of randomized controlled trials by Charlotte Groenset, Magnus N. Bech, Mary Jarden, Nina Høgdal, Martin Hutchings, Charlotte Suetta, Jan Christensen

“…Methods: A systematic search was conducted in six electronic databases and trials registers on November 15, 2023. Peer-reviewed randomized controlled trials (RCTs) comparing exercise intervention with controls/usual care in adults (≥18 years) diagnosed with Hodgkin’s lymphoma and non-Hodgkin’s lymphoma undergoing chemotherapy were considered for inclusion. …”
Get full text

Assessing the effectiveness and the feasibility of a group-based treatment for self-stigma in people with mental disorders in routine mental health services in North-East Italy: study protocol for a pragmatic multisite randomized controlled trial by Antonio Lasalvia, Luca Bodini, Doriana Cristofalo, Veronica Fin, Philip T. Yanos, Chiara Bonetto

“…Trials…”
Get full text

Comparison of Chest-to-Back Skin-to-Skin Contact and Chest-to-Chest Skin-to-Skin Contact on the Risk of Oxygen Desaturation and Change in Heart Rate in Low Birth Weight and/or Premature Babies: A Randomized Controlled Clinical Trial by Sisay Gere, Yemane Berhane, Alemayehu Worku

“…We used a parallel-group randomized controlled clinical trial. Peripheral arterial blood oxygen saturation (SpO2) and heart rate (HR) were measured using an OxiMaxN-600X Pulse Oximeter. …”
Get full text

To Dissect or Not to Dissect? The Surgeon’s Perspective on the Prediction of Greater Than or Equal to 4 Axillary Lymph Node Metastasis in Early-Stage Breast Cancer: A Comparative Analysis of the Per-Protocol Population of the SINODAR-ONE Clinical Trial by Corrado Tinterri, MD, Giuseppe Canavese, MD, Damiano Gentile, MD

Get full text

Emergency Medicine Palliative Care Access (EMPallA): protocol for a multicentre randomised controlled trial comparing the effectiveness of specialty outpatient versus nurse-led telephonic palliative care of older adults with advanced illness by Jeanne Cho, Michael Hill, Corita R Grudzen, Deborah J Shim, Abigail M Schmucker, Keith S Goldfeld, Lauren Southerland, Jeffrey M Caterino, Marie-Carmelle Elie, Robert Swor, Susan E Cohen, Arum Kim, Joseph Lowy, Jennifer S Scherer, Nancy E Bael, Ellin Gafford, Joshua Lakin, Paige Barker, Angela Chmielewski, Jennifer Kapo, Audrey Tan, Rebecca Yamarik, Susan Salz, Stephen Ryan, Anne Kim, Isabel Castro, Amelia Hargrove, Laura Stuecher, Nora Daut, Juanita Booker-Vaughns, Garrett K Chan, J Nicholas Dionne-odom, Patrick Dunn, Robert Galvin, Ernest A Hopkins III, Margaret M Maguire, Neha Reddy Pidatala, Dawn Rosini, Sally Welsh, Karen Jubanyik, Ada L Rubin, Kei Ouchi, Rebecca Murray, Nicole Tang, Marie Bakitas, Abraham Brody, Caroline Blaum, Mara Flannery, Richard Tamirian, Pamela Marsack, Jennifer Bonito, Romilla Batra, Donna C Sadasivan, Eric David Isaacs, Constance L Kizzie-Gillett, William K Vaughan, Pluscedia G Williams, Angela Young-Brinn

“…The primary outcome will measure change in patient quality of life.Ethics and dissemination Institutional Review Board approval was obtained at all study sites. Trial results will be submitted for publication in a peer-reviewed journal.Trial registration number NCT03325985; Pre-results.…”
Get full text

FERN: is it possible to conduct a randomised controlled trial of intervention or expectant management for early-onset selective fetal growth restriction in monochorionic twin pregnancy – protocol for a prospective multicentre mixed-methods feasibility study by Kerry Woolfall, Jamie J Kirkham, Jane Sandall, Mariana Popa, Enrico Lopriore, Mark Turner, Shakila Thangaratinam, Aris T Papageorghiou, Andrew Sharp, Lawrence Impey, Andy Healey, Jessica Mendoza, Asma Khalil, Dharmintra Pasupathy, Brigitte Vollmer, Zarko Alfirevic, Rajeswari Parasuraman, Jan Deprest, Richard Edmund Ashcroft, Kurt Hecher, Smriti Prasad, Baskaran Thilaganathan, Richard J Jackson, Tracy Karen Mitchell, Natasha Fenwick, Monique C Haak, Liesbeth Lewi, Shauna Leven, Fabricio Da Silva Costa, Odai Yaghi, Tracey Ricketts, George Attilakos, Carolyn Bailie, Christine Cornforth, Mark Denbow, Louise Hardman, Jane Harrold, Joel Marsden, Tommy Mousa, Surabhi Nanda, Michelle Watson, Karen Wilding, Dilly Anumba, Edward D Johnstone, Yoav Yinon, Ahmet Baschat

“…These management options have never been investigated in a randomised controlled trial (RCT). The best management option is unknown, and there are many challenges for a potential RCT. …”
Get full text

The combination of kidney function variables with cell cycle arrest biomarkers identifies distinct subphenotypes of sepsis-associated acute kidney injury: a post-hoc analysis (the... by Dimitri Titeca-Beauport, Momar Diouf, Delphine Daubin, Ly Van Vong, Guillaume Belliard, Cédric Bruel, Yoann Zerbib, Christophe Vinsonneau, Kada Klouche, Julien Maizel

Subjects: “…The AKI-CHECK study was registered at ClinicalTrials.gov (NCT02812784)…”
Get full text

Web Destekli Bilgi Okuryazarlığı Eğitiminin Etkinliğinin Belirlenmesi: Hemşirelik Öğrencileri Üzerinde Randomize Olmayan Kontrollü Çalışma by Sibel Küçükoğlu, Ayşe Gedikçi Öndoğan

Subjects: “…non-randomized controlled trial…”
Get full text

Legality of bringing to administrative responsibility for an offense under Art. 130 Code of Ukraine on Administrative Offenses: retrospective analysis by K. O. Chyshko

Subjects: Get full text

Effect of intermittent urethral catheter clamping combined with active urination training (ICCAUT) strategy on postoperative urinary dysfunction after radical rectal cancer surgery: single-centre randomised controlled trial (ICCAUT -1) study protocol by Yuchen Guo, Quan Wang, Tingting He, Sen Liang, Yunan Guan, Jianan Sun, Haiyan Hu

“…All primary and secondary outcomes will be reported in peer-reviewed publications and at conference presentations.Trial registration number The trial was registered at ClinicalTrials.gov website, NCT06241703.…”
Get full text

HIV self-testing alone or with additional interventions, including financial incentives, and linkage to care or prevention among male partners of antenatal care clinic attendees in Malawi: An adaptive multi-arm, multi-stage cluster randomised trial. by Augustine T Choko, Elizabeth L Corbett, Nigel Stallard, Hendramoorthy Maheswaran, Aurelia Lepine, Cheryl C Johnson, Doreen Sakala, Thokozani Kalua, Moses Kumwenda, Richard Hayes, Katherine Fielding

“…We investigated the impact of HIVST alone or with additional interventions on the uptake of testing and linkage to care or prevention among male partners of antenatal care clinic attendees in a novel adaptive trial.<h4>Methods and findings</h4>An adaptive multi-arm, 2-stage cluster randomised trial was conducted between 8 August 2016 and 30 June 2017, with antenatal care clinic (ANC) days (i.e., clusters of women attending on a single day) as the unit of randomisation. …”
Get full text

Efficacy and safety of perioperative sintilimab plus platinum-based chemotherapy for potentially resectable stage IIIB non-small cell lung cancer (periSCOPE): an open-label, single-arm, phase II trialResearch in context by Xiangyang Yu, Chujian Huang, Longde Du, Chunguang Wang, Yikun Yang, Xin Yu, Shengcheng Lin, Chenglin Yang, Hongbo Zhao, Songhua Cai, Zhe Wang, Lixu Wang, Xiaotong Guo, Baihua Zhang, Zhentao Yu, Jie He, Kai Ma

“…The key secondary endpoints included the objective response rate (ORR), radical resection (R0) rate, pathological complete response (pCR) rate, event-free survival (EFS), disease-free survival (DFS), OS, treatment-related adverse events (TRAEs), surgical complications, and surgery delay rate. This trial is registered with the Chinese Clinical Trial Registry (ChiCTR2000040673). …”
Get full text

Acute effects of virtual reality exercise bike games on psychophysiological outcomes in college North-African adolescents with cerebral palsy: A randomized clinical trial [version 2; peer review: 1 approved, 2 approved with reservations] by Mehdi Chlif, Amine Ghram, Makrem Soudani, Faical Farhat, Helmi Ben Saad

“…The trial was reported in accordance with the CONSORT reporting guidelines.…”
Get full text

Transcutaneous spinal cord stimulation combined with robotic-assisted body weight-supported treadmill training enhances motor score and gait recovery in incomplete spinal cord injury: a double-blind randomized controlled clinical trial 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. …”
Get full text

Comparison of the impact of intermittent fasting diet alone or in conjunction with probiotic supplementation versus calorie-restricted diet on inflammatory, oxidative stress, and antioxidant capacity biomarkers in women with polycystic ovary syndrome: A randomized placebo-controlled trial by Sepide Talebi, Sakineh Shab-Bidar, Gholamreza Askari, Hamed Mohammadi, Ashraf Moini, Kurosh Djafarian

“…The present study did not reveal significant improvements in BP, inflammatory markers, OS, or antioxidant capacity with either eTRE alone or eTRE combined with probiotics compared to a standard DCR among obese women diagnosed with PCOS. Trial Register no: IRCT20121110011421N5.…”
Get full text