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For: Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin JA, Doré CJ, Parulekar WR, Summerskill WSM, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med 2013;158:200-7. [PMID: 23295957 PMCID: PMC5114123 DOI: 10.7326/0003-4819-158-3-201302050-00583] [Citation(s) in RCA: 4558] [Impact Index Per Article: 379.8] [Reference Citation Analysis] [What about the content of this article? (0)] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/24/2022]  Open
Number Cited by Other Article(s)
1
Luker S, Doveton A, Manuel K, Adey-Wakeling Z, Jaggard D, Crotty M, Cameron ID, Karnon J, McNaughton H, Ullah S, Laver K. Take charge after long COVID: a mixed methods randomised controlled pilot study protocol. Ann Med 2025;57:2516694. [PMID: 40492405 DOI: 10.1080/07853890.2025.2516694] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/23/2024] [Revised: 04/28/2025] [Accepted: 05/13/2025] [Indexed: 06/12/2025]  Open
2
Albrecht M, Hunfeld M, Arkesteijn-Muit A, Dulfer K, de Hoog M, de Jong G, de Jonge R, Lamoré A, Nadkarni V, Buysse C. A Dutch nationwide pediatric cardiac arrest registry with long-term follow-up - towards an international prognostication guideline. Resusc Plus 2025;24:100976. [PMID: 40491775 PMCID: PMC12148594 DOI: 10.1016/j.resplu.2025.100976] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Collaborators] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/17/2025] [Revised: 04/14/2025] [Accepted: 04/30/2025] [Indexed: 06/11/2025]  Open
3
Hopewell S, Chan AW, Collins GS, Hróbjartsson A, Moher D, Schulz KF, Tunn R, Aggarwal R, Berkwits M, Berlin JA, Bhandari N, Butcher NJ, Campbell MK, Chidebe RCW, Elbourne D, Farmer A, Fergusson DA, Golub RM, Goodman SN, Hoffmann TC, Ioannidis JPA, Kahan BC, Knowles RL, Lamb SE, Lewis S, Loder E, Offringa M, Ravaud P, Richards DP, Rockhold FW, Schriger DL, Siegfried NL, Staniszewska S, Taylor RS, Thabane L, Torgerson D, Vohra S, White IR, Boutron I. CONSORT 2025 Statement: Updated Guideline for Reporting Randomized Trials. JAMA 2025;333:1998-2005. [PMID: 40228499 DOI: 10.1001/jama.2025.4347] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 04/16/2025]
4
Tersa-Miralles C, Bravo C, Bellon F, Masbernat-Almenara M, Rubí-Carnacea F, Arnaldo ER. A web-based workplace exercise intervention among office workers with spinal pain: Protocol of a mixed methods study. PLoS One 2025;20:e0325376. [PMID: 40489458 DOI: 10.1371/journal.pone.0325376] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/08/2024] [Accepted: 05/08/2025] [Indexed: 06/11/2025]  Open
5
Wang YR, Liu CZ, Cong Y, Xi YW, Xu YY, Li B, Zhou Y, Tu JF, Fu YM, Chen W, Wang LQ, Shi GX. Acupuncture as an Adjunctive Therapy to Etoricoxib for Patients with Acute Gouty Arthritis: Protocol for a Multicenter Randomized Controlled Trial. J Pain Res 2025;18:2889-2900. [PMID: 40520812 PMCID: PMC12165196 DOI: 10.2147/jpr.s523657] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/19/2025] [Accepted: 05/22/2025] [Indexed: 06/18/2025]  Open
6
Zilcha-Mano S, Bouknik Y, Malka M, Krasovsky T. An individual-specific understanding of how synchrony becomes curative: study protocol. BMC Psychiatry 2025;25:587. [PMID: 40481468 PMCID: PMC12142965 DOI: 10.1186/s12888-025-06539-3] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/12/2024] [Accepted: 01/26/2025] [Indexed: 06/11/2025]  Open
7
Kunas B, Jung O, Schranz C, Schmoigl-Tonis M, Ploessnig M, Laireiter AR. Personalizing mHealth Interventions for Occupational Stress: Protocol for a Randomized Pilot Study. JMIR Res Protoc 2025;14:e68012. [PMID: 40460419 DOI: 10.2196/68012] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/25/2024] [Revised: 03/25/2025] [Accepted: 03/26/2025] [Indexed: 06/11/2025]  Open
8
Sposato LA, Ayan D, Ahmed M, Fridman S, Mandzia JL, Elrayes M, Lodol F, Khaw AV, Mai LM, Bogiatzi C, Casserly C, Fraser JA, Chan R, Florendo Cumbermack A, Markovic N, Yu Y, Debicki D, Fleming L, Beauchamp B, Lambourn L, Mayich M, Milroy L, Sharma M, Pandey S, Bagur R. Extended CT angiography versus standard CT angiography for the detection of cardioaortic thrombus in patients with ischaemic stroke and transient ischaemic attack (DAYLIGHT): a prospective, randomised, open-label, blinded end-point trial. Lancet Neurol 2025;24:489-499. [PMID: 40409313 DOI: 10.1016/s1474-4422(25)00111-5] [Citation(s) in RCA: 1] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/16/2025] [Revised: 03/17/2025] [Accepted: 03/21/2025] [Indexed: 05/25/2025]
9
Kearney N, Connolly D, Bahramian K, Sheill G, Coghlan-Lynch K, O'Sullivan J, Coleman N, O'Hanlon Brown C, Gallagher D, O'Gorman C, O'Brien C, Tierney A, Rankin K, O'Neill L, Guinan E. A Flexible Individualised ExeRcise programme for cancer patients during ChEmotherapy (FIERCE): Protocol for a randomised controlled feasibility trial. Contemp Clin Trials 2025;153:107923. [PMID: 40268238 DOI: 10.1016/j.cct.2025.107923] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/11/2024] [Revised: 04/04/2025] [Accepted: 04/19/2025] [Indexed: 04/25/2025]
10
Hammersley ML, Dekker GA, Gurrin LC, Hoon EA, Schurer S, Lynch JW, Aldred M, Dalton J, Fletcher CJ, Smithers LG. The use of financial incentives for smoking cessation in pregnant women: A parallel-group randomised controlled trial protocol. Addiction 2025;120:1260-1270. [PMID: 39916446 PMCID: PMC12046475 DOI: 10.1111/add.70004] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/24/2024] [Accepted: 01/08/2025] [Indexed: 05/03/2025]
11
Sadigh G, Duan F, Gareen IF, Hancock J, Sicks JD, Hawley S, Shankaran V, Torres M, Wagner LI, Carlos RC. Effectiveness of out-of-pocket cost COMmunication and financial navigation (CostCOM) in cancer patients: Study protocol for ECOG-ACRIN EAQ222CD. Contemp Clin Trials 2025;153:107889. [PMID: 40147544 DOI: 10.1016/j.cct.2025.107889] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/20/2024] [Revised: 02/14/2025] [Accepted: 03/23/2025] [Indexed: 03/29/2025]
12
Harada T, Shirasaka T, Baba T, Mizusawa A, Villaroman A, Noguera-Caoile R, Mercado MA, Peralta J, Hatto K, Kanamori S. Residential cognitive-behavioral therapy versus therapeutic community for patients with methamphetamine use disorders in the Philippines: A randomized controlled trial. Addict Behav Rep 2025;21:100605. [PMID: 40290633 PMCID: PMC12032182 DOI: 10.1016/j.abrep.2025.100605] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/01/2024] [Revised: 03/17/2025] [Accepted: 04/10/2025] [Indexed: 04/30/2025]  Open
13
Pirie K, Traer E, Winter N, Brown W, Riedel B, Myles PS. Analgesia using intrathecal morphine to improve quality of recovery after minimally invasive major abdominal surgery (AIM Trial): study protocol for a multicentre randomised controlled trial. BJA OPEN 2025;14:100386. [PMID: 40201333 PMCID: PMC11978349 DOI: 10.1016/j.bjao.2025.100386] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 11/06/2024] [Accepted: 02/07/2025] [Indexed: 04/10/2025]
14
Spampinato S, Tanderup K, Barcellini A, Burchardt E, Eminowicz G, Šegedin B, Stankiewicz M, Valgma M, Kirchheiner K. Impact of the Common Terminology Criteria for Adverse Events (CTCAE) evolution on toxicity scoring in gynaecological radiotherapy. Radiother Oncol 2025;207:110881. [PMID: 40220903 DOI: 10.1016/j.radonc.2025.110881] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/11/2024] [Revised: 03/31/2025] [Accepted: 04/01/2025] [Indexed: 04/14/2025]
15
Agostinho PAG, Bedoya ÉAP, Cota AR, Chaves SFN, Oliveira CEP, Carneiro-Júnior MA, Moreira OC. Flywheel resistance training: Functionality and strength in older women - A randomized controlled trial. J Bodyw Mov Ther 2025;42:573-582. [PMID: 40325725 DOI: 10.1016/j.jbmt.2025.01.023] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/05/2024] [Revised: 12/23/2024] [Accepted: 01/17/2025] [Indexed: 05/07/2025]
16
Tang VFY, Jiang D, Kahlon M, Chow EOW, Yeung DYL, Aubrey R, Chou KL. A three-arm randomized controlled trial protocol: Effects of telephone-based, layperson-delivered wisdom-enhancement narrative therapy and empathy-focused interventions on loneliness, social, and mental health in older adults. Contemp Clin Trials Commun 2025;45:101479. [PMID: 40235625 PMCID: PMC11999345 DOI: 10.1016/j.conctc.2025.101479] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/12/2024] [Revised: 03/03/2025] [Accepted: 03/28/2025] [Indexed: 04/17/2025]  Open
17
Wayne PM, Vining R, Long CR, Burton WM, Litrownik D, Guzman J, Kilgore K, Hagan TJ, Rist PM, Kowalski MH. Combined chiropractic care and Tai Chi for chronic neck pain: A protocol for a pilot randomized trial. Contemp Clin Trials Commun 2025;45:101482. [PMID: 40321971 PMCID: PMC12049832 DOI: 10.1016/j.conctc.2025.101482] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/15/2024] [Revised: 02/13/2025] [Accepted: 04/04/2025] [Indexed: 05/08/2025]  Open
18
Aghajani R, Dehghani E, Khonji MS, Naghdi S, Nakhostin Ansari N, Dommerholt J, Nakhostin-Ansari A. Effect of dry needling on quadriceps muscles fatigue in taekwondo players: A protocol for a triple-blinded randomized controlled trial. Contemp Clin Trials Commun 2025;45:101476. [PMID: 40235623 PMCID: PMC11997412 DOI: 10.1016/j.conctc.2025.101476] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/02/2024] [Revised: 03/22/2025] [Accepted: 03/28/2025] [Indexed: 04/17/2025]  Open
19
Losina E, Collins JE, Kumara M, Ehrlich-Jones L, Opare-Addo M, Safran-Norton C, Segal NA, Mitchell LM, Kopp PT, Selzer F, Mass H, Paskewicz M, Chang RW, Dunlop D, Chen AF, Lerner S, Chin S, Pellegrini C, Katz JN. KArAT (Knee Arthroplasty Activity Trial): Rationale and design features of a multicenter randomized controlled trial. OSTEOARTHRITIS AND CARTILAGE OPEN 2025;7:100512. [PMID: 40276263 PMCID: PMC12019487 DOI: 10.1016/j.ocarto.2024.100512] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/28/2024] [Accepted: 08/12/2024] [Indexed: 04/26/2025]  Open
20
Liang F, Young J, Koutsidis G, Lara Gallegos J. The effects of extra virgin olive oil or butter on cardiovascular biomarkers in European and Chinese males in the UK: A pilot randomised crossover trial. Nutr Health 2025;31:485-498. [PMID: 37461824 DOI: 10.1177/02601060231187516] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 06/18/2025]
21
Ponting C, Baer RJ, Blackman K, Blebu B, Felder JN, Oltman S, Tabb KM, Jelliffe Pawlowski L. Transforming Health and Reducing Perinatal Anxiety Through Virtual Engagement: Protocol for a Randomized Controlled Trial. JMIR Res Protoc 2025;14:e70627. [PMID: 40446294 PMCID: PMC12166326 DOI: 10.2196/70627] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/27/2024] [Revised: 05/02/2025] [Accepted: 05/05/2025] [Indexed: 06/18/2025]  Open
22
Linde DS, Le HM, Vu DTK, Dang NAT, Nguyen AT, Vu TP, Nguyen XB, Nguyen CD, Meyrowitsch DW, Søndergaard J, Vinter CA, Bygbjerg IC, Rasch V, Nguyen TD, Gammeltoft TM, Nguyen DK. A co-created self-care and informal support intervention targeting women with gestational diabetes mellitus in northern Vietnam (VALID-II): a protocol for a two-arm non-randomised feasibility study. Pilot Feasibility Stud 2025;11:73. [PMID: 40442746 PMCID: PMC12121233 DOI: 10.1186/s40814-025-01657-x] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/04/2023] [Accepted: 05/09/2025] [Indexed: 06/02/2025]  Open
23
Kroese T, Andratschke N, Belka C, Corradini S, Marschner S, Liermann J, Hörner-Rieber J, Fink C, Debus J, Silvia F, Tanadini-Lang S, Pouymayou B, Mencarelli A, Fesslmeier D, Schiess A, Guckenberger M, Mayinger M. Online adaptive stereotactic body radiotherapy for localized prostate cancer in patients with lower urinary tract symptoms and/or prostate hyperplasia (X-SMILE). Radiat Oncol 2025;20:90. [PMID: 40437508 PMCID: PMC12117833 DOI: 10.1186/s13014-025-02653-4] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/04/2024] [Accepted: 04/29/2025] [Indexed: 06/01/2025]  Open
24
Hackett SS, Foscarini-Craggs P, Aafjes-van Doorn K, Franklin M, Riaz M, Zubala A, Condie J, McKinnon I, Iranpour A, Leigh Harrison T, Rose S, Randell E, McNamara R. Secure care (forensic) hospital evaluation of manualised interpersonal art-psychotherapy (SCHEMA): A randomised controlled trial protocol. NIHR OPEN RESEARCH 2025;5:21. [PMID: 40242277 PMCID: PMC12000804 DOI: 10.3310/nihropenres.13801.1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Accepted: 05/13/2025] [Indexed: 04/18/2025]
25
Taylor RS, Burrell E, O'Hare C, Thomson EA, Placzek A, Bollen JC, Cleland JGF, Cowie A, Dalal HM, Deaton C, Doherty PJ, Dudman K, Fraser H, Frost J, Greaves C, Hartshorne-Evans N, Hillsdon M, Ibbotson T, Jarallah M, Jolly K, McConnachie A, McIntosh E, Smith V, Squire I, Taylor L, van Beurden S, Lang CC, REACH-HFpEF Investigators. Clinical effectiveness and cost-effectiveness of the rehabilitation enablement in chronic heart failure facilitated self-care rehabilitation intervention for people with heart failure with preserved ejection fraction and their caregivers: rationale and protocol for a multicentre randomised controlled trial - REACH-HFpEF trial. BMJ Open 2025;15:e094254. [PMID: 40436450 PMCID: PMC12121609 DOI: 10.1136/bmjopen-2024-094254] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/26/2024] [Accepted: 03/13/2025] [Indexed: 06/01/2025]  Open
26
Moors JJE, Xu Z, Xie K, Rashad A, Vladu O, Egger J, Röhrig R, Hölzle F, Puladi B. Full-thickness skin graft versus split-thickness skin graft for fasciocutaneous radial forearm free flap donor site closure: a systematic review and meta-analysis. Syst Rev 2025;14:118. [PMID: 40426263 PMCID: PMC12108030 DOI: 10.1186/s13643-025-02863-7] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/21/2024] [Accepted: 05/11/2025] [Indexed: 05/29/2025]  Open
27
Gray L, Coppack RJ, Barker-Davies R, Cassidy RP, Bennett AN, Caplan N, Atkinson G, Bradshaw L, Chauhan J, Lunt KM, Hughes L, Ladlow P. Efficacy and acceptability of different blood flow restriction training interventions during the rehabilitation of military personnel with lower limb musculoskeletal injuries: protocol for a two-phase randomised controlled trial. BMJ Open 2025;15:e096643. [PMID: 40425246 PMCID: PMC12107567 DOI: 10.1136/bmjopen-2024-096643] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/15/2024] [Accepted: 05/09/2025] [Indexed: 05/29/2025]  Open
28
Diaz KM, Murdock ME, Clark AW, Kumar S, Jerez V, Serafini MA, Xu C, Boudreaux BD, Romero EK, Aguirre J, Seid H, Nandakumar R, Ginsberg H, Shimbo D, Cheung YK. Breaking up prolonged sedentary behavior to improve cardiometabolic health (BREAK2): protocol for a dose-finding adaptive randomization trial. BMC Public Health 2025;25:1929. [PMID: 40414835 DOI: 10.1186/s12889-025-22250-0] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/30/2024] [Accepted: 03/07/2025] [Indexed: 05/27/2025]  Open
29
Vellingiri K, Acharya AM, Bhat AK. A protocol for randomized controlled trial on early active flexion versus passive flexion mobilization therapy for Spaghetti wrist injuries. J Orthop Surg Res 2025;20:506. [PMID: 40410794 PMCID: PMC12102783 DOI: 10.1186/s13018-025-05884-z] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/10/2025] [Accepted: 05/02/2025] [Indexed: 05/25/2025]  Open
30
Aebi PS, Adam L, Haller M, Bardoczi JB, Gencer B, Bonnet F, Beer JH, Carballo S, Christ-Crain M, Feller M, Gabutti L, Haynes AG, Moutzouri E, Chocano-Bedoya PO, Bassetti S, Escher R, Egger M, Poortvliet RKE, Schuetz P, Trelle S, Wertli MM, Zekry D, Méan M, Aujesky D, Bauer D, Blum MR, Rodondi N. Rationale and design of 'discontinuing statins in multimorbid older adults without cardiovascular disease (STREAM)': study protocol of a randomised non-inferiority clinical trial. BMJ Open 2025;15:e093833. [PMID: 40409969 PMCID: PMC12104904 DOI: 10.1136/bmjopen-2024-093833] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/17/2024] [Accepted: 05/09/2025] [Indexed: 05/25/2025]  Open
31
Zhou X, Li X, Chen N, Chen Z, Yu H, Liang J, Fan Q, Zhu X, Zhang T, Zhou X, Du Q. Efficacy of sensorimotor training combined with core strength training for low back pain in adult idiopathic scoliosis: a study protocol for a randomized controlled trial. BMJ Open 2025;15:e091476. [PMID: 40409968 PMCID: PMC12104929 DOI: 10.1136/bmjopen-2024-091476] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/22/2024] [Accepted: 04/29/2025] [Indexed: 05/25/2025]  Open
32
Langa JC, Sidat M, Sacarlal J, Moon TD. Re-introduction of India ink testing as a low-cost laboratory diagnostic for cryptococcosis among HIV infected patients in Southern Mozambique: An implementation research protocol. PLoS One 2025;20:e0324792. [PMID: 40408629 PMCID: PMC12101839 DOI: 10.1371/journal.pone.0324792] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/13/2025] [Accepted: 04/28/2025] [Indexed: 05/25/2025]  Open
33
Nielsen CP, Samsøe E, Offersen BV, Lorenzen EL, Persson G, Mortensen HR, Nissen HD, Vogelius IR, Kallehauge JF, Muren LP, Brincker M, Felter MVO, Dahlrot RH, Hokland SB, Schytte T, Havelund BM, Weber B, Møller DS, Serup-Hansen E, Jensen K, Jakobsen KL, Josipovic M, Krogh SL, Lukacova S, Hoffmann L, Hansen CR. Recommendations for radiotherapy quality assurance in clinical trials. Radiother Oncol 2025:110950. [PMID: 40412533 DOI: 10.1016/j.radonc.2025.110950] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/18/2024] [Revised: 04/30/2025] [Accepted: 05/19/2025] [Indexed: 05/27/2025]
34
Baharudin MH, Mokhtar SA, Azman AZF, Mohd Nazan AIN. Utilizing Theory of Planned Behaviour to increase intention to participate in hepatitis C treatment therapy among Methadone maintenance therapy clients (MMT) in Malaysia: A cluster randomised control trial. PLoS One 2025;20:e0324718. [PMID: 40403097 PMCID: PMC12097622 DOI: 10.1371/journal.pone.0324718] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/04/2024] [Accepted: 04/29/2025] [Indexed: 05/24/2025]  Open
35
Nagai M, Noma H, Sakata M, Oi H, Shigematsu J, Matsumura K, Furukawa TA, Nakajima S. Reasonable access to brief behavioural insomnia treatment among medical and psychiatric outpatients (RABBIT): a multicentre randomised controlled trial protocol. BMJ Open 2025;15:e094602. [PMID: 40404326 PMCID: PMC12096993 DOI: 10.1136/bmjopen-2024-094602] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/04/2024] [Accepted: 04/27/2025] [Indexed: 05/24/2025]  Open
36
Elazaly H, Dimitriou IM, Maleitzke T, Dahne M, Jaecker V, Maerdian S, Tafelski S, Diekhoff T, Lindner T, Akgün D, Mielke AM, Paksoy A, Amini DA, Planatscher EM, Leopold V, González-Khatib S, Köhli PC, Niemann M, Hildebrandt A, Oehme S, Palmowski Y, Paraskevaidis M, Schönnagel L, Braun SB, Pumberger M, Hardt S, Stricker S, Akyüz L, Grütz G, Schaller S, Lauterbach L, Volcksdorff M, Mödl L, Textor M, Ort M, Reinke S, Stöckle U, Perka C, Duda GN, Schmidt-Bleek K, Geissler S, Winkler T. ILOBONE: A phase I/IIa randomized controlled trial to assess the safety and feasibility of local iloprost therapy for enhancing proximal humerus fracture healing- a pilot study design. J Orthop Surg Res 2025;20:498. [PMID: 40405317 PMCID: PMC12096472 DOI: 10.1186/s13018-025-05865-2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/18/2025] [Accepted: 04/27/2025] [Indexed: 05/24/2025]  Open
37
Paraj D, Bhat AK, Acharya A, Kunder MA. Comparison of the clinical and functional outcomes of two immobilisation protocols after arthroscopic peripheral triangular fibrocartilage complex (TFCC) repair in adults: a single-centre, double-blinded randomised controlled trial protocol. BMJ Open 2025;15:e095855. [PMID: 40398936 PMCID: PMC12096963 DOI: 10.1136/bmjopen-2024-095855] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/30/2024] [Accepted: 05/09/2025] [Indexed: 05/23/2025]  Open
38
Ruiz MT, da Conceição Rodrigues E, Christoffel MM, de Resende CV, Cavalcanti MC, Ferreira MG, da Silva JA, da Silva KEPO, Wernet M, Gomes ALM, Raponi MBG, de Oliveira JF, Contim D, Linares AM. Effectiveness of individualized breastfeeding counseling during the dyad's stay in rooming-in: a randomized, multicenter, open and parallel study. Int Breastfeed J 2025;20:41. [PMID: 40400003 PMCID: PMC12093738 DOI: 10.1186/s13006-025-00710-y] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/15/2024] [Accepted: 03/11/2025] [Indexed: 05/23/2025]  Open
39
Tomaskovic A, Weber V, Ochmann DT, Neuberger EW, Lachtermann E, Brahmer A, Haller N, Hillen B, Enders K, Eggert V, Zeier P, Lieb K, Simon P. Multimodal Web-Based Telerehabilitation for Patients With Post-COVID-19 Condition: Protocol for a Randomized Controlled Trial. JMIR Res Protoc 2025;14:e65044. [PMID: 40397936 DOI: 10.2196/65044] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/02/2024] [Revised: 03/22/2025] [Accepted: 03/26/2025] [Indexed: 05/23/2025]  Open
40
Lavoie A, Dubé V. Web-Based Nursing Intervention to Promote Physical Activity Among Older Adults After Coronary Revascularization: Protocol for Mixed Method Pilot Study. JMIR Res Protoc 2025;14:e67678. [PMID: 40397502 DOI: 10.2196/67678] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/17/2024] [Revised: 02/24/2025] [Accepted: 03/21/2025] [Indexed: 05/22/2025]  Open
41
Rocke M, Knochenhauer E, Thams F, Antonenko D, Fromm AE, Jansen N, Aziziaram S, Grittner U, Schmidt S, Vogelgesang A, Brakemeier EL, Flöel A. Neuromodulation through brain stimulation-assisted cognitive training in patients with post-chemotherapy subjective cognitive impairment (Neuromod-PCSCI) after breast cancer: study protocol for a double-blinded randomised controlled trial. BMJ Open 2025;15:e096162. [PMID: 40398955 PMCID: PMC12096976 DOI: 10.1136/bmjopen-2024-096162] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/05/2024] [Accepted: 04/24/2025] [Indexed: 05/23/2025]  Open
42
Baumel A, Aderka IM. The Impact of Mechanisms of Action on Adherence and Outcomes in Self-Guided Digital Mental Health Interventions: Protocol for a Randomized Controlled Trial With Mediation Analysis. JMIR Res Protoc 2025;14:e71238. [PMID: 40397492 DOI: 10.2196/71238] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/14/2025] [Revised: 03/12/2025] [Accepted: 04/21/2025] [Indexed: 05/22/2025]  Open
43
Ombasa L, Miller J, Ware L, Abbotts-Holmes H, Tang J, Gasser O, Fraser K, Bayer S, Kemp R, Costello R, Highton A, Evans J, Merry T, Schultz M, Frampton C, Gearry R, McNabb W, Roy N. Impact of Mānuka Honey on Symptoms and Quality of Life in Individuals With Functional Dyspepsia: Protocol for a Feasibility Randomized Controlled Trial. JMIR Res Protoc 2025;14:e66417. [PMID: 40397937 DOI: 10.2196/66417] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/14/2024] [Revised: 03/28/2025] [Accepted: 04/04/2025] [Indexed: 05/23/2025]  Open
44
Peralta-Gámez MS, Gómez de Quero Córdoba M, Reverté-Villarroya S, Cuesta-Martínez R. Comparison of Traditional and Ultrasound-Guided Techniques for Vascular Access in Patients with Difficult Venous Access in Emergency Departments: Randomized Clinical Trial Protocol. NURSING REPORTS 2025;15:177. [PMID: 40423208 DOI: 10.3390/nursrep15050177] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/18/2025] [Revised: 05/11/2025] [Accepted: 05/16/2025] [Indexed: 05/28/2025]  Open
45
Mueller M, Visini M, Mueller SA, Stadler T, Rajan GP, Morand GB, Hool SL, Schanne DH, Balermpas P, Limacher A, Chan S, Trelle S, Elicin O, Giger R. DeintensiF: Standard versus individualized deintensified follow-up after curative treatment in head and neck cancer: protocol of a randomized pilot study. Pilot Feasibility Stud 2025;11:69. [PMID: 40380278 DOI: 10.1186/s40814-025-01651-3] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/08/2024] [Accepted: 04/28/2025] [Indexed: 05/19/2025]  Open
46
Everhart KC, Wirth MD, Iskersky VN, Dail RB. Evaluating a blood warming device for packed red blood cell transfusions to decrease hypothermia in very preterm infants: A randomised control trial protocol. Transfus Med 2025. [PMID: 40371767 DOI: 10.1111/tme.13143] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/18/2024] [Revised: 04/16/2025] [Accepted: 04/29/2025] [Indexed: 05/16/2025]
47
Wzorek-Łyczko K, Piwowarczyk A, Woźniak W, Kuchar E, Szymański H. A randomised trial of pleuran in paediatric acute gastroenteritis. Sci Rep 2025;15:16912. [PMID: 40374943 PMCID: PMC12081596 DOI: 10.1038/s41598-025-94893-3] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/25/2024] [Accepted: 03/17/2025] [Indexed: 05/18/2025]  Open
48
Yuan Y, Wang YJ, Guo A, Wang WG, Wang W, Liu PL, Shen ZX, Xie JR, Liu KL, Zhao M, Zuo JL, Liu K, Shi ZY, Liu ZL, Weng XS, Liu JP. Tibetan medicine pain relieving plaster for treatment of knee osteoarthritis: protocol for a multi-center, randomized, and positive drug controlled trial. Front Med (Lausanne) 2025;12:1597183. [PMID: 40443514 PMCID: PMC12119513 DOI: 10.3389/fmed.2025.1597183] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/20/2025] [Accepted: 05/01/2025] [Indexed: 06/02/2025]  Open
49
Smyth E, Politi L, Guinan E, Mockler D, O'Neill L. Dissemination planning in exercise oncology trials-a systematic review of trial protocols. Support Care Cancer 2025;33:473. [PMID: 40369320 PMCID: PMC12078369 DOI: 10.1007/s00520-025-09532-4] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/08/2024] [Accepted: 05/07/2025] [Indexed: 05/16/2025]
50
Hinten AE, Schluter PJ, van Deurs J, van Noorden L, McLay L. Outcomes of participating in the Let's Play programme on 0-5-year-old autistic children's engagement and caregivers' stress: study protocol for a parallel randomised controlled trial. BMJ Open 2025;15:e081030. [PMID: 40379306 PMCID: PMC12083321 DOI: 10.1136/bmjopen-2023-081030] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/16/2023] [Accepted: 04/11/2025] [Indexed: 05/19/2025]  Open
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