Comparison of two skin protection regimes for the Prevention of Incontinence-associated Dermatitis in geriatric care (PID): a study protocol for an exploratory randomised controlle... by Jan Kottner, Monira El Genedy-Kalyoncu, Alexandra Fastner, Bettina Völzer, Kathrin Raeder, Konrad Neumann, Nils Axel Lahmann

“…Results will be disseminated through peer-reviewed open-access journals and international conferences.Trial registration number ClinicalTrials.gov (NCT05403762) and German Clinical Trials Register (Deutsches Register Klinischer Studien, or DRKS) (DRKS00028954).…”
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Same-day versus rapid ART initiation in HIV-positive individuals presenting with symptoms of tuberculosis: Protocol for an open-label randomized non-inferiority trial in Lesotho an... by Felix Gerber, Robina Semphere, Blaise Lukau, Palesa Mahlatsi, Timeo Mtenga, Tristan Lee, Maurus Kohler, Tracy Renée Glass, Alain Amstutz, Mamello Molatelle, Peter MacPherson, Nthuseng Bridgett Marake, Marriot Nliwasa, Irene Ayakaka, Rachael Burke, Niklaus Labhardt

“…<h4>Design and methods</h4>SaDAPT is an open-label, pragmatic, parallel, 1:1 individually randomized, non-inferiority trial comparing two strategies for the timing of ART initiation in PWH with presumptive TB ("ART first" versus "TB results first"). …”
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A mobile-based randomized controlled trial on the feasibility and effectiveness of screening for major depressive disorder: study protocol by M. M. E. Zandbergen, E. E. L. Jansen, L. J. Jabbarian, H. J. de Koning, I. M. C. M. de Kok

“…Methods This study will be a three-arm, parallel randomized control trial (RCT) performed in a multi-ethnic population within the municipality of Rotterdam (the Netherlands). …”
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Japi 2.0, a gaming platform to stimulate cognitive and non-cognitive skills in early childhood: protocol for a pilot randomized controlled trial by Jorge Gaete, Saray Ramírez, Cristian A. Rojas-Barahona, Valentina Romo, Natalia Ríos, Ricardo Araya

“…Methods This is a pilot randomized controlled trial, parallel-group type, where the school-based implementation of “Japi 2.0” training is compared to standard school curricula in control schools. …”
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Efficacy and Safety of Murivenna Anal Infiltration Compared to Diltiazem Topical Application in Chronic Anal Fissure: Protocol for a Prospective, Randomized, Open-Label Clinical Tr... by Pratap Shankar KM, Indu Puthan Purayil, Palengara Binitha, Amit Kumar Rai, Sophia Jameela, Azeem Ahmad, Chandra Sekhara Rao Bhogavalli, Narayanam Srikanth, Rabinarayan Acharya

“…MethodsThis is an open-labeled, randomized, controlled parallel group clinical trial with a sample size of 66 participants to be randomized and allocated in a 1:1 ratio to 2 groups. …”
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Effects of a structured, family-supported, and patient-centred advance care planning on end-of-life decision making among palliative care patients and their family members: protoco... by Doris Y. P. Leung, Joyce O. K. Chung, Helen Y. L. Chan, Raymond S. K. Lo, Kevin Li, Po Tin Lam, Nancy H. Y. Ng

“…Methods This is a 2-arm parallel group randomized controlled trial with follow-ups at 6 and 12 months. …”
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The MAR method versus the visual estimation method in predicting external blood loss: a randomized controlled study by Betul Akbuga Ozel, Gurkan Ozel, Elmas Burcu Mamak Ekinci, Ahmet Eren Demirtola, Gizem Sahin, Gokcen Aksoy, Ilke Yanikyurek, Mehmet Ufuk Karaaslan

“…A randomized, double-blind, parallel-group, controlled, and educational study was conducted involving 140 medical and paramedic students. …”
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Effect of high-flow nasal oxygen therapy on cardiac cycle efficiency in coronary artery disease patients undergoing endoscopy: study protocol for randomised controlled trial by Sheng Wang, Tingting Ma, Fang Xie, Mu Jin, Xiaorui Zhou

“…The results will be submitted to a peer-reviewed journal for publication.Trial registration number ChiCTR2400086887.…”
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Does routine spirometry impact on clinical decisions and patient-related outcome measures of children seen in respiratory clinics: an open-label randomised controlled trial by Anne B Chang, Stephanie T Yerkovich, Julie M Marchant, Ian B Masters, Wicharn Boonjindasup, Margaret S McElrea

“…Introduction There is limited evidence on the efficacy of using spirometry routinely in paediatric practice for improving outcomes.Objective To determine whether the routine use of spirometry alters clinical decisions and patient-related outcome measures for children managed by respiratory paediatricians.Methods We undertook a parallel open-label randomised controlled trial involving children (aged 4–18 years) able to perform spirometry in a specialist children’s hospital in Australia. …”
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Comparing physiological and psychological effects of virtual reality vs. traditional high-intensity interval training in healthy individuals: results from a preliminary pilot rando... by Jonathan Robinson, Mohammad Haziq Bin Abdul Razak

“…Objectives The study aimed to explore the feasibility, efficacy, and potential effects of VR compared to traditional HIIT in terms of physiological and psychological outcomes in physically active adults. Methods Using a parallel-design pilot randomised controlled trial, 10 participants completed the study and were randomly allocated to either the VR group (n = 5) or non-VR group (n = 5). …”
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Effectiveness of Yijinjing exercise in the treatment of early-stage knee osteoarthritis: a randomized controlled trial protocol by Yihang Wang, Fei Yao, Min Fang, Guangxin Guo, Xiruo Xu, Kaiqiu Lu, Xuanying Zhu, Yijia Gu, Guangpu Yang

“…Therefore, we designed a randomised controlled trial to evaluate the effectiveness of Yijinjing exercise on patients with early-stage KOA.Methods and analysis This is a parallel-design, two-arm, analyst assessor-blinded, randomised controlled trial. …”
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Treatment outcomes of pulpotomy versus pulpectomy in vital primary molars diagnosed with symptomatic irreversible pulpitis: protocol for a non-inferiority randomised controlled tri... by Nebu Philip, Joe Mathew Cherian, Mebin George Mathew, Abi M. Thomas, Sunaina Jodhka, Nino John, Bharat Suneja, Mandeep Duggal

“…Methods/design This clinical study is a parallel, two-armed, open label, non-inferiority RCT with a 1:1 allocation ratio between the experimental intervention arm (pulpotomy) and the active comparator arm (pulpectomy). …”
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tREatment of trIaNgular FibrOcaRtilage ComplEx Ruptures (REINFORCER): protocol for randomised, controlled, blinded, efficacy trial of triangular fibrocartilage complex tears by Teemu Karjalainen, Jarkko Jokihaara, Ville M Mattila, Aleksi Reito, Antti Kaivorinne, Toni Luokkala, Mikko Petteri Räisänen, Robert Gvozdenovic, Maria Wilcke, Turkka Anttila, Annele Pönkkö, Carsten Lauridsen, Tuukka Tanskanen, Matti Juntunen, Olli-Pekka Kangasniemi, Morten Kjaer, Heli Lähdeniemi, Panu Nordback, Shabir Rashidi, Janne Soikkeli, Jerzy Stiasny, Elin Sward, Lars Vadstrup, Johanna Vonkieseritzky

“…Each stratum consists of two parallel 1:1 arms, comparing the efficacy of (1) debridement of central or radial tear with placebo surgery and (2) repair of peripheral tear with physiotherapy. …”
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Efficacy and safety of a house dust mites allergoid in patients with allergic rhinitis—PROACAROS study: protocol for a randomized controlled trial by Inmaculada Buendía-Jiménez, María Matas-Ros, Teresa Garriga-Baraut, Albert Roger-Reig, Ana Tabar-Purroy, on behalf of the PROACAROS investigator group

“…Methods We will perform a double-blind, placebo-controlled, randomized parallel group phase III clinical trial to assess the clinical efficacy and safety of a polymerized Dermatophagoides pteronyssinus and Dermatophagoides farinae allergen extract mixture (Beltavac®) to treat perennial AR in children and adults. …”
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Evaluating the necessity of booster sessions in relapse prevention for depression: a longitudinal study by Jón Ingi Hlynsson, Jón Ingi Hlynsson, Tómas Kristjánsson, Gerhard Andersson, Gerhard Andersson, Gerhard Andersson, Per Carlbring, Per Carlbring, the ACTUA research group

“…Our findings indicate that the efficacy of behavioral activation and physical activity may be even greater than previously reported, a testament to the lasting effects of internet-based psychotherapy.Clinical trail registrationClinicalTrials.gov, identifier NCT01619930.…”
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Evaluation of the Clinical Nursing Effects of a Traditional Chinese Medicine Nursing Program Based on Care Pathways for Patients With Type 2 Diabetes: Protocol for a Randomized Con... by Yanchun Zhao, Ting Huang, Yanli Chen, Songmei Li, Juan Zhao, Xu Han, Qing Ni, Ning Su

“…MethodsThis study uses a prospective, randomized, single-blind, parallel-controlled design. Based on sample size calculations, the study will include 594 patients with diabetes, with 2 groups of 297 patients: an observation group will receive a TCM nursing program based on clinical pathways, while a control group will receive routine care. …”
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Efficacy of clindamycin and LACTIN-V for in vitro fertilization patients with vaginal dysbiosis: a randomised double-blind, placebo-controlled multicentre trial by Thor Haahr, Nina la Cour Freiesleben, Mette Brix Jensen, Helle Olesen Elbaek, Birgit Alsbjerg, Rita Laursen, Lisbeth Prætorius, Henriette Svarre Nielsen, Anja Pinborg, Vibeke Hartvig Boujida, Thomas Roland Pedersen, Axel Skafte-Holm, Jørgen Skov Jensen, Peter Humaidan

“…IVF patients were randomised prior to embryo transfer into three parallel groups 1:1:1. Group one (CLLA) received clindamycin 300 mg ×2 daily for 7 days followed by vaginal LACTIN-V until the day of pregnancy scan. …”
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Efficacy and Safety of Pafuramidine versus Pentamidine Maleate for Treatment of First Stage Sleeping Sickness in a Randomized, Comparator-Controlled, International Phase 3 Clinical... by Gabriele Pohlig, Sonja C Bernhard, Johannes Blum, Christian Burri, Alain Mpanya, Jean-Pierre Fina Lubaki, Alfred Mpoo Mpoto, Blaise Fungula Munungu, Patrick Mangoni N'tombe, Gratias Kambau Manesa Deo, Pierre Nsele Mutantu, Florent Mbo Kuikumbi, Alain Fukinsia Mintwo, Augustin Kayeye Munungi, Amadeu Dala, Stephen Macharia, Constantin Miaka Mia Bilenge, Victor Kande Betu Ku Mesu, Jose Ramon Franco, Ndinga Dieyi Dituvanga, Richard R Tidwell, Carol A Olson

“…<h4>Methods</h4>This was a Phase 3, multi-center, randomized, open-label, parallel-group, active control study where 273 male and female patients with first stage Trypanosoma brucei gambiense HAT were treated at six sites: one trypanosomiasis reference center in Angola, one hospital in South Sudan, and four hospitals in the Democratic Republic of the Congo between August 2005 and September 2009 to support the registration of pafuramidine for treatment of first stage HAT in collaboration with the United States Food and Drug Administration. …”
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Effectiveness of interactive voice response-call for life mHealth tool on adherence to anti-retroviral therapy among young people living with HIV: A randomized trial in Uganda. by Agnes Bwanika Naggirinya, David B Meya, Maria Sarah Nabaggala, Grace Banturaki, Agnes Kiragga, Joseph Rujumba, Peter Waiswa, Rosalind Parkes-Ratanshi

“…<h4>Methods</h4>This was a randomized parallel trial. Young people aged between15-24 living with HIV, initiating ART, or on ART for not more than 6 months at three ART clinics were recruited and randomized to a ratio of 1:1 to either standard of care or the intervention "Call for Life-Interactive Voice Response" with standard of care, between 12th August 2020 and 1st June 2022. …”
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Self-aligning prosthetic device for older patients with vascular-related amputations: protocol for a randomised feasibility study (the STEPFORWARD study) by Elizabeth Coleman, Catriona McDaid, Natasha Mitchell, Judith Watson, Kerry Bell, Cleveland Barnett, Martin Twiste, Fergus Jepson, Abayomi Salawu, Dennis Harrison, Natalie Vanicek

“…The findings will be disseminated via peer-reviewed research publications, articles in relevant newsletters, presentations at relevant conferences and the patient advisory group.Trial registration number ISRCTN15043643.…”
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