Validation of new diagnostic indices to simplify hyponatremia therapy assessment in patients on thiazide diuretics: study protocol of a randomized, controlled, parallel-group trial... by Karin Vogt, David Widmer, Mark Kirsch, Mirjam Christ-Crain, Laura Potasso

“…Methods This is a randomized (1:1 ratio) controlled, superiority, parallel-group single-center trial. In total, 136 participants with TAH < 130 mmol/l will be enrolled and randomly assigned to undergo either aSID/ChU-guided therapy of TAH or standard of care during hospitalization. …”
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Influenza vaccination in patients with acute heart failure (PANDA II): study protocol for a hospital-based, parallel-group, cluster randomized controlled trial in China by Yiqun Zhang, Rong Liu, Yangyang Zhao, Zhiyan Wang, Chi Wang, Qiang Li, Dorothy Han, Craig S. Anderson, Xin Du, Jianzeng Dong

“…Methods The second Population Assessment of Influenza and Disease Activity (PANDA II) study is a two-arm, parallel-group, county-level hospital-based, cluster randomized controlled trial to determine the benefits and risks of full access to routine free influenza vaccination before hospital discharge, compared to routine limited use of influenza vaccination, on the primary endpoint of death or hospital readmission. …”
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Effectiveness of photobiomodulation therapy on pain intensity in postpartum women with nipple or perineal trauma: protocol for a multicentre, double-blinded, parallel-group, random... by Fernanda G Surita, Edna Jéssica Lima Gondim, Simony Lira Nascimento, Maria Victória Candida Gaitero, Ticiana Aparecida Alves de Mira, Andrea de Vasconcelos Gonçalves

“…Results will be disseminated to the health science community.Trial registration number Brazilian Registry of Clinical Trials (RBR-2qm8jrp).…”
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Intraoperative low-dose esketamine on postoperative quality of recovery in patients undergoing open gynecologic surgery: a double-blinded, parallel-group, placebo- controlled trial by Zhi-Yu Geng, Yan Zhang, Xin Yan, Jun Hu, Ran Cui, Lin-Lin Song, Hui-Cheng Song

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Effects of passive blood-flow-restriction and electromyostimulation on ICU-acquired weakness (ICUAW): a study protocol for a randomized-controlled, parallel-group clinical trial by Alexander Franz, Katharina Friederike Wolf, Julika Behrens, Björn Koos, Michael Adamzik, Stefan Felix Ehrentraut

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Utility of a personalised Bronchiectasis Action Management Plan (BAMP) for children with bronchiectasis: protocol for a multicentre, double-blind parallel, superiority randomised c... by Anne B Chang, Peter S Morris, Stephanie T Yerkovich, Julie M Marchant, Anne Cook, Kobi L Schutz, Lesley Versteegh, Jack Roberts

“…The results of the trial will be submitted for publication and the BAMP made available free online.Trial registration number Australia and New Zealand Clinical Trials Register ACTRN12618000604202.…”
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Canakinumab for the treatment of postprandial hypoglycaemia: study protocol for a randomised, placebo-controlled, parallel-group, double-blind, multicentric, superiority trial—the... by António Ferreira, Lia Bally, Marco Cattaneo, David Herzig, Matthias Hepprich, Justus Fischer, Marc Donath

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Efficacy and Safety of Electroacupuncture Through Nerve Stimulation in Patients With Anxiety Disorders: Protocol for a Randomized, Assessor-Blind, Three-Arm, Parallel-Group Clinica... by In Chul Jung, Dong-Hoon Kang, Sunyoung Choi, Yujin Choi, Ojin Kwon, Hye Jeong Kook, Daeun Lee, Yang-Chun Park, Jieun Kim

“…MethodsThis study is a randomized, assessor-blind, three-arm, parallel-group clinical trial comprising the PC6 electroacupuncture group, TF4 electroacupuncture group, and a control group. …”
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Multicentre, randomised, double-blind, parallel controlled trial to investigate timing of platelet inhibition after coronary artery bypass grafting: TOP-CABG trial study by Yang Wang, Lihua Zhang, Shengshou Hu, Kai Chen, Xin Yuan, Qing Chu, Yingli Zheng

“…The results of the trial will be submitted for publication in a peer-reviewed journal.Trial registration number NCT05380063.…”
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Efficacy of a Personalized mHealth App in Improving Micronutrient Supplement Use Among Pregnant Women in Karachi, Pakistan: Parallel-Group Randomized Controlled Trial by Khadija Vadsaria, Rozina Nuruddin, Nuruddin Mohammed, Iqbal Azam, Saleem Sayani

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Multicentre, randomised, single-blind, parallel group trial to compare the effectiveness of a Holter for Parkinson’s symptoms against other clinical monitoring methods: study proto... by Juan Carlos Martinez-Castrillo, Maria Alvarez, Dolores Vilas, Ernest Balaguer, Ignacio Alvarez, Jon Infante, Silvia Jesús, Marina Mata, Pablo Mir, Pau Pastor, María Sierra, Lydia Vela, Isabel Gonzalez, Ana Rita Santos, Daniel Lopez, Antonio Hernández, Francisco Perez, Nuria Caballol, Antonio Salvador, Judith Jimenez, Alejandro Rodríguez-Molinero, Jorge Hernández-Vara, Antonio Miñarro, Carlos Pérez-López, Àngels Bayes-Rusiñol, David A Pérez-Martínez, Anna Planas-Ballvé, Mariateresa Buongiorno, Núria López, Mª Isabel Morales, Gema Sánchez, María Asunción Ávila, Anna Prats, Alexandre Gironell, Álvaro Sánchez-Ferro, Antonio Méndez, Elisabet Franquet, Sonia Escalante, Laura Muñoz-Delgado, Daniel Macías-García, Astrid Adarmes-Gómez, José Mª Salom, Silvia Martí, Carlos Leiva, Victor M. Puente, Irene Navalpotro, Sara Lucas, Antonio Koukoulis, Mª Gema Alonso, Mª Esther Cubo, Mª Victoria Sánchez, Carmen Borrúe, Mª Concepción Jimeno, Mª José Gómez, Lina Carazo, Alfredo López, Mª Pilar Solís, Rubén Alonso, Jessica González, Javier Ruiz, Ana Vinagre, Ioana Croitoru, Pilar Sánchez, Elisa Gamo, Sabela Novo, Esteban Peña, Esther Blanco, Rafael García, José López, Teresa Muñoz, Lucía Flores, Rocío García-Ramos, Eva López, Lourdes Ispierto, Ramiro Álvarez, Esther Catena, Berta Solano, Anna Cots, Lydia López Manzanares, Marta Recio-Bermejo

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Genicular nerve radiofrequency ablation, phenol neurolysis or conservative medical management in patients with knee osteoarthritis: protocol for the RADIOPHENOL randomised controll... by Markus W Hollmann, Johan Haumann, Bram Thiel, Marc B Godfried, Jan-Willem Kallewaard, Paul R de Wit, Rienk van Beek, Monique Schokker, Carin Wensing, Gezina Oei, Derk A van Kampen, Lars Elzinga, Gijs Hendriks, Jeroen van de Heiden, Jan Willem Coumou

“…We aim to publish our results in international peer-reviewed journals.Trial registration details ClinicalTrials.gov NCT06094660, including the WHO Trial Registration data set items. …”
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Evaluation of a transdiagnostic mental health intervention in German primary care: study protocol for a parallel-group, two-arm, cluster randomised controlled pilot study by Christopher Ebert, Marie Vogel, Jochen Gensichen, Hanna Reif, Lena Grögor, Lukas Junker, Thomas Ehring, Alkomiet Hasan, Stefan Leucht, Kirsten Lochbühler, for the POKAL-Group

“…Findings may inform the design of a main trial by identifying barriers to the transdiagnostic intervention’s feasibility and acceptability, whilst advancing treatment delivery protocols to support effectiveness. Trial registration The protocol for this study has been registered with the German Clinical Trials Register: DRKS00033386, Date of registration: 18th of March 2024, https://drks.de/search/en/trial/DRKS00033386 .…”
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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 tri... by Philip J Schluter, Laurie McLay, Jenna van Deurs, Lauren van Noorden, Ashley E Hinten

“…Results will be shared regardless of magnitude or direction of effect.Trial registration number ACTRN12622001139763.…”
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Effects of pericapsular nerve group (PENG) block on postoperative recovery in elderly patients with hip fracture: study protocol for a randomised, parallel controlled, double-blind... by Yuhui Li, Wuhua Ma, Wei Luo, Huiyi Wu, Quehua Luo, Jianhui Liang, Jieting Wu, Yanhua Ou

“…The results of this study will be published in peer-reviewed international journals.Trial registration number ChiCTR2100042341.…”
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Efficacy and safety of herbal medicine (Dangguijagyag-san) for primary dysmenorrhea: study protocol for a randomized, double-blind, placebo-controlled, parallel-group, multi-center... by Hye Lin Woo, Hae Ri Ji, Siin Kim, Hae Sun Suh, Kwan-Il Kim, Jin Moo Lee, Kyoung Sun Park

“…Methods: This protocol details a randomized, double-blind, parallel-group, multi-center, investigator-initiated, controlled trial evaluating treatment of primary dysmenorrhea. …”
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Effects of body weight-supported Tai Chi Yunshou training on upper limb motor function in stroke patients: A three-arm parallel randomized controlled trial. by Liying Zhang, Xiaoming Yu, Wangsheng Liao, Jiening Wang, Yan Lu, Naizhen Wang, Zhou Huanxia

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Clinical benefits of modifying the evening light environment in an acute psychiatric unit: A single-centre, two-arm, parallel-group, pragmatic effectiveness randomised controlled t... by Håvard Kallestad, Knut Langsrud, Melanie Rae Simpson, Cecilie Lund Vestergaard, Daniel Vethe, Kaia Kjørstad, Patrick Faaland, Stian Lydersen, Gunnar Morken, Ingvild Ulsaker-Janke, Simen Berg Saksvik, Jan Scott

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Thiamine dose response in human milk with supplementation among lactating women in Cambodia: study protocol for a double-blind, four-parallel arm randomised controlled trial by Kyly C Whitfield, Hou Kroeun, Tim Green, Frank T Wieringa, Mam Borath, Prak Sophonneary, Jeffrey R Measelle, Dare Baldwin, Lisa N Yelland, Shalem Leemaqz, Kathleen Chan, Jelisa Gallant

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Evaluating the Efficacy and Safety of 48-Week Low-Dose Dienogest Administration in Patients With Dysmenorrhea Caused by Endometriosis: Protocol for a Randomized, Open-Label, Parall... by Kyoko Kikuno, Ryuta Asada, Takuma Ishihara, Yoshimasa Bomoto, Saki Murase, Yoko Ueda, Tomomi Shiga, Yoh Hayasaki, Tatsuro Furui, Satoko Matsuzaki, Masahiko Takemura, Kazutoshi Matsunami, Makoto Kubo, Naoki Ito, Masanori Isobe, Ken-ichirou Morishige

“…MethodsThis randomized, open-label, parallel-group, dose-comparison, multicenter trial follows the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 guidelines and is conducted at 6 centers in Japan. …”
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