An individualized physical function improvement program for frailty elderly using goal attainment scaling (GAS) as evaluation method: protocol for a randomized controlled trial by Yu Kang, Zi-Cheng Qi, Meng-Tian Guo, Xiao-Juan Wang

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Study protocol for a multicentre randomised controlled trial using music prehabilitation to reduce preoperative anxiety before oncological colorectal surgery: the MU-PRIOR trial by Erwin Birnie, Markus Klimek, Johannes Jeekel, Jorrit Gustav Verhoeven, Roos Geensen, Thomas Lodewijk Adriaan Dirven, Willem Jaap Rogier Rietdijk

“…The trial will be carried out following the updated Declaration of Helsinki principles and Good Clinical Practice guidelines. …”
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Influence of combined vitamin D3 supplementation and resistance exercise training on musculoskeletal health in older men and women (EXVITD): protocol for a randomised controlled tr... by Carolyn A Greig, Neil Gittoes, Janet Lord, Susan Lanham-New, Alison Doyle, Anneka Elizabeth Welford, Julie Robinson

“…The study is being conducted according to the principles of the Declaration of Helsinki.Trial registration numberNCT02467153; Post-results.…”
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Home-based Intervention with Semaglutide Treatment of Neuroleptic-Related Prediabetes (HISTORI): protocol describing a prospective, randomised, placebo controlled and double-blinde... by Peter Haulund Gæde, Jan Frystyk, Niels Bilenberg, Ashok Ainkaran Ganeshalingam, Nicolai Gundtoft Uhrenholt, Sidse Arnfred

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Lifestyle Intervention in Chronic Ischaemic Heart Disease and Type 2 Diabetes (the LeIKD study): study protocol of a prospective, multicentre, randomised, controlled trial by Julia Schoenfeld, Martin Halle, Pia von Korn, Hanna Sydow, Sarah Neubauer, André Duvinage, Anja Mocek, Sophia Dinges, Bjoern Hackenberg, Mario Weichenberger, Volker Amelung, Stephan Mueller

“…The study will be conducted according to the World Medical Association Declaration of Helsinki, and results will be published in articles and reports. …”
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Examining Romosozumab Adherence and Side Effects in Osteoporotic Patients After Surgical Fracture Fixation: A Comparative, Descriptive, and Hypothesis-Generating Study with Non-Fra... by Amarildo Smakaj, Umberto Tarantino, Riccardo Iundusi, Angela Chiavoghilefu, Lorenzo Abbondante, Chiara Salvati, Chiara Greggi, Elena Gasbarra

“…Objectives: The study aims to evaluate adherence to Romosozumab treatment in osteoporotic patients after surgical fracture fixation and compare side effects with non-fractured controls on the same therapy. Methods: This retrospective case–control study was conducted at the Orthopaedic Department of Policlinico Universitario di Roma “Tor Vergata”, following the principles of the Declaration of Helsinki. …”
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Transforming Households with Refraction and Innovative Financial Technology (THRIFT): study protocol for a randomised controlled trial of vision interventions and online banking am... by Nathan Congdon, Malabika Sarker, Mike Clarke, Rohit C Khanna, Lynne Lohfeld, Prabhath Piyasena, Ving Fai Chan, Graeme Mackenzie, Sridevi Rayasam, Atonu Rabbani, Asha Latha Mettla, Achyuta Adhvaryu, Enam Haque, Mrittika Barua, Sharmin Akter Shitol, Ishrat Binte Aftab, Nagamani Challa, Payal Sangani, Lovemore Nyasha Sigwadhi, H M Masudur Rahman, Sonia Pant, Anant Nyshadham, Sadiq Alam, Ella Gudwin, Abu Shonchoy

“…The trial is conducted in accordance with the Declaration of Helsinki and national regulations in Bangladesh, and results will be published in open-access, peer-reviewed journals.Trial registration number NCT05510687; ClinicalTrials.gov.…”
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Comparing non-ischaemic heart preservation (NIHP) with ischaemic static cold storage of donor hearts in adult cardiac transplantation: study protocol for a randomised controlled tr... by Johan Nilsson, Henry Pigot, Stig Steen

“…It will be conducted according to the Declaration of Helsinki and relevant local and international regulations. …”
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Combined cold-water immersion and breathwork may be associated with improved mental health and reduction in the duration of upper respiratory tract infection - a case–control study... by Jan Czarnecki, Katarzyna Nowakowska-Domagała, Łukasz Mokros

“…Two groups were matched based on a case–control principle: the first one (the control group) comprised participants who did not declare nor CWI practice, nor STP practice. …”
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Effects of 6 weeks of cryotherapy plus compression therapy after total or unicompartmental knee arthroplasty: protocol for a single-centre, single-blind randomised controlled trial by Reinoud W Brouwer, Astrid J de Vries, Haci K Aksakal

“…The study will be conducted in accordance with the Declaration of Helsinki and Good Clinical Practice regulations, and personal data will be handled in agreement with the Dutch Personal Data Protection Act (AGV). …”
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Determinants of uncontrolled blood pressure among adult hypertensive patients on follow-up at Negelle and Adola General Hospital, Guji Zone, Southern Ethiopia: facility-based case... by Azmach Habtegiorgis, Alo Edin, Kebebew Lemma, Takala Utura, Dereje Girma, Dawit Getachew, Teshome Bekele

“…Finally, at p < 0.05, statistical significance was declared. Results A sample of 384 respondents (128 cases and 256 controls) were included, for a response rate of 100%. …”
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Review of Uganda’s high-risk Ebola preparedness activities enabling prompt control of imported Ebola Virus Outbreak from the Democratic Republic of Congo, June 2019 by Sandra Nabatanzi, Allan Niyonzima Muruta, Issa Makumbi, Alex Riolexus Ario, Benon Kwesiga, Atek Atwiine Kagirita, Lilian Bulage, Bernard Lubwama, Doreen Nsiimire Gonahasa, Paul Mbaka, Innocent Komakech, Maureen Nabatanzi, Felix Ocom, Jaco Homsy, Vance Brown, Joseph Ojwang, David Matseketse, Ida Marie Ameda, Simon Kyazze, Allan Mpairwe, Julie Harris, Henry Gatyanga Mwebesa, Miriam Nanyunja

“…Introduction: On 1 August 2018, the Democratic Republic of Congo declared its tenth Ebola Virus Disease (EVD) outbreak in North-Kivu province, 100 km from the Uganda border. …”
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A pleiotropy-informed Bayesian false discovery rate adapted to a shared control design finds new disease associations from GWAS summary statistics. by James Liley, Chris Wallace

“…However, existing methods require distinct control samples between studies. Here, we extend the technique to allow for some or all controls to be shared, increasing applicability. …”
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Glimepiride monotherapy versus combination of glimepiride and linagliptin therapy in patients with HNF1A-diabetes: a protocol for a randomised, double-blinded, placebo-controlled t... by Torben Hansen, Tina Vilsbøll, Filip Krag Knop, Alexander Sidelmann Christensen, Heidi Storgaard, Sofie Hædersdal

“…Introduction Hepatocyte nuclear factor 1α (HNF1A)-diabetes is the most common monogenetic subtype of diabetes. Strict glycaemic control is crucial for a good prognosis for patients with HNF1A-diabetes. …”
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Perioperative treatment with tranexamic acid in melanoma (PRIME): protocol for a Danish multicentre randomised controlled trial investigating the prognostic and treatment-related i... by Henrik Schmidt, Lisbet Rosenkrantz Hölmich, Karoline Assifuah Kristjansen, Andreas Engel Krag, Marie Louise Bønnelykke-Behrndtz

“…The study will be conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice. …”
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Study protocol for a cluster randomised controlled trial testing the effectiveness of the ‘High schools High on life’ intervention on reducing excessive drinking in Danish high sch... by Veronica Sofie Clara Pisinger, Morten Grønbæk, Sofie Hoffmann, Johanne Aviaja Rosing, Janne Schurmann Tolstrup, Lau Thygesen, Rikke Krølner

“…The intervention includes a school environmental component to limit access to alcohol at school, a school-educational component to change social norms around alcohol among first year students and a parental component addressing parents’ knowledge and attitudes towards alcohol.Methods and design The study will employ a cluster randomised controlled study design and will include a random sample of 16 high schools randomly allocated 1:1 to either intervention or control group. …”
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Assessing the effectiveness of perioperative s-ketamine on new-onset headache after resective epilepsy surgery (ESPAIN-trial): protocol for a randomised, double-blind, placebo-cont... by Sander van Kuijk, Rob P W Rouhl, Jiske Cornelia Theresa Sloekers, Michael Bos, Govert Hoogland, Caroline Bastiaenen, Maurice Theunissen, Kim Rijkers, Jim Dings, Albert Colon, Olaf Elisabeth Maria Ghislaine Schijns

“…This study will be conducted in accordance with the Dutch Medical Research Involving Human Subjects Act and the Declaration of Helsinki. The results of this trial will be publicly disclosed and submitted for publication in an international peer-reviewed scientific journal.Trial registration number NTR6480.…”
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Robot-assisted versus video-assisted thoracoscopic thymectomy for stage I–II thymic epithelial tumour: a protocol for the first multicentre, randomised controlled clinical trial by Bin Wu, Jian Gao, Yu Qi, Xinyu Yang, Shuai Wang, Lijie Tan, Fei Liang, Yong-Qiang Ao, Junkan Zhu, Zhenguo Sun, Jiahao Jiang, Yuansheng Zheng, Xifei Jiang, Weiming Yue, Jianyong Ding

“…This phase II randomised controlled trial aims to provide the first direct comparative analysis of perioperative outcomes between RATT and VATT in stage I–II TETs.Methods and analysis This phase II clinical trial is a prospective, multicentre, randomised controlled study. …”
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Maternal and umbilical cord plasma purine concentrations after oral carbohydrate loading prior to elective Cesarean delivery under spinal anesthesia: a randomized controlled trial by Katarzyna Kotfis, Dominika Jamioł-Milc, Arleta Wojciechowska, Aleksandra Szylińska, Arleta Drozd, Małgorzata Zimny, Barbara Dołęgowska, Sebastian Kwiatkowski, Violetta Dziedziejko, Krzysztof Safranow

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Optimised transcranial direct current stimulation (tDCS) for fibromyalgia—targeting the endogenous pain control system: a randomised, double-blind, factorial clinical trial protoco... by Luis Castelo-Branco, Elif Uygur Kucukseymen, Dante Duarte, Mirret M El-Hagrassy, Camila Bonin Pinto, Muhammed Enes Gunduz, Alejandra Cardenas-Rojas, Kevin Pacheco-Barrios, Yiling Yang, Paola Gonzalez-Mego, Anayali Estudillo-Guerra, Ludmilla Candido-Santos, Ines Mesia-Toledo, Haley Rafferty, Wolnei Caumo, Felipe Fregni

“…Given that FM is associated with a defective endogenous pain control system and central sensitisation, combining interventions such as transcranial direct current stimulation (tDCS) and aerobic exercise (AE) to modulate pain-processing circuits may enhance pain control.Methods and analysis A prospective, randomised (1:1:1:1), placebo-controlled, double-blind, factorial clinical trial will test the hypothesis that optimised tDCS (16 anodal tDCS sessions combined with AE) can restore of the pain endogenous control system. …”
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