EXamining the feasibility of exerCisE to manage symptoms of Lupus (EXCEL): a protocol for a randomised controlled pilot study by John Reynolds, Katie Hesketh, Matthew Cocks, Megan Quickfall, Alex J Wadley, Scott Green, Jet Veldhuijzen Van Zanten

“…Blood and self-reported measures will be compared with a healthy control (HC) group (n=15, age and body mass index matched) at baseline only.Ethics and dissemination A favourable ethical opinion was given by South East Scotland Research Ethics Committee (22/SS/0082). …”
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Development of a core measurement set for research in degenerative cervical myelopathy: a study protocol (AO Spine RECODE-DCM CMS) by Robert Chen, Angus G K McNair, Vafa Rahimi-Movaghar, Julio C Furlan, Benjamin M Davies, Oliver D Mowforth, Iwan Sadler, Bizhan Aarabi, Brian K Kwon, Michael G Fehlings, James S Harrop, Armin Curt, Ellen Sarewitz, Carl Moritz Zipser, Timothy F Boerger, Mark R N Kotter, James Milligan, Lindsay Tetreault, Danyal Khan, Keng Siang Lee, Alvaro Yanez Touzet, Ricardo Rodrigues-Pinto, James D Guest, Sukhvinder Kalsi-Ryan, Shirley Widdop

“…A preliminary CMS review scheduled at 4 years from release.Ethics and dissemination Ethical approval was obtained from the University of Cambridge (HBREC2019.14). …”
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Study protocol for key interventions to improve the follow-up adherence postcervical precancerous lesion treatment in Ethiopia: a pragmatic randomised controlled trial by Adamu Addissie, Eva Johanna Kantelhardt, Eric Sven Kroeber, Sefonias Getachew, Muluken Gizaw, Abel Shita, Alemnew Destaw, Eyerusalem Getachew, Miresa Midaksa, Sophie Rossner

“…Study participants in the intervention group will receive the stated interventions plus the standard care, while the control group will receive only the standard care. …”
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A prospective, cross-sectional study to establish age-specific reference intervals for neonates and children in the setting of clinical biochemistry, immunology and haematology: th... by Susan M Donath, Monsurul Hoq, Vicky Karlaftis, Susan Mathews, Janet Burgess, John Carlin, Paul Monagle, Vera Ignjatovic

“…Analytical testing is performed according to the standard operating procedures used for clinical samples. …”
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Informatization of the processes of administration of the quality of medical services in surgical hospitals by Ya.S. Bereznytskyi, V.Ya. Bereznytskyi, O.V. Hudoshyna, N.D. Chuhrienko, G.V. Bereznytska, Ye.V. Zalyhina, Yu.B. Dianova, E.A. Rynska, L.N. Ksykevich

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Protocol for a first-in-human feasibility study of T regulatory cells (TR004) for inflammatory bowel disease using (ex vivo) Treg expansion (TRIBUTE) by Jennifer Clough, Peter Irving, A Toby Prevost, Graham M Lord, Joana Vasconcelos, James B Canavan, Beverley Rodger, D Macallan

“…The primary endpoint is defined as the occurrence of dose-limiting toxicity occurring within 5 weeks post-infusion.Ethics and dissemination The study protocol and related documents have been approved by a NHS Research Ethics Committee, the Health Research Authority and the Medicines and Healthcare products Regulatory Agency for Clinical Trial Authorisation. …”
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Diagnostic accuracy of CCTA-derived versus angiography-derived quantitative flow ratio (CAREER) study: a prospective study protocol by Liang Zhang, Yang Chen, Cheng Li, Ming Li, Shaofeng Guan, Xinkai Qu, Tingwen Weng, Qian Gan, Zehang Li, Wenzheng Han, Xinrong Zhai, Lin Qi, Xifeng Chang, Shengxian Tu

“…The primary endpoint is the diagnostic accuracy of CT-QFR in identifying haemodynamically significant coronary stenosis with FFR as the reference standard. The major secondary endpoint is the non-inferiority of CT-QFR compared with QFR in the patients without extensively calcified lesions.Ethics and dissemination The study was approved by the Ethics Committee of Huadong Hospital Affiliated to Fudan University (2020K192). …”
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Bedside hyperspectral imaging for the evaluation of microcirculatory alterations in perioperative intensive care medicine: a study protocol for an observational clinical pilot stud... by Thilo Hackert, Thomas Bruckner, Maximilian Dietrich, Sebastian Marx, Felix Nickel, Beat Peter Müller-Stich, Markus A Weigand, Florian Uhle, Thorsten Brenner, Karsten Schmidt

“…Study results will be submitted to peer-reviewed journals and medical conferences.Trial registration number DRKS00017313; Pre-results.…”
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Effects of community family doctors-led intervention for self-management and medication adherence in type 2 diabetes mellitus patients: study protocol of a cluster randomised contr... by Yue Chen, Biqi Ren, Ningsheng Wang, Shuang Lei, Shuzhi Lin, Lianye Liu, Yufang Xiang, Bianling Feng

“…The secondary outcome is the proportion of people whose blood sugar and glycosylated haemoglobin are under control in the 3rd and 6th months.Ethics and dissemination The study proposal was approved by the Biomedical Ethics Committee of the Medical Department of Xi’an Jiaotong University (no. 2021-1371). …”
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Melatonin supplementation for the treatment of infantile spasms: protocol for a randomised placebo-controlled triple-blind trial by Jing Wang, Tao Xu, Miao Liu, Jian Chen, Guang Yang, Weiwei Feng, Yulin Sun, Xiuyu Shi, Liping Zou

“…Sleep quality and safety will also be assessed.Ethics and dissemination The protocol for this study was approved by the Ethics Committee of Chinese PLA General Hospital (reference number S2020-337-01) and was reported according to the Standard Protocol Items: Recommendations for Interventional Trials statement. …”
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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

“…IAD incidence of the control and intervention groups will be compared to estimate effect sizes, and the procedural feasibility of the intervention will be tested to plan a possible subsequent confirmatory randomised controlled trial.Ethics and dissemination The study received the approval of the ethics committee of Charité–Universitätsmedizin Berlin (EA4/043/22). …”
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Comparison of glycosylated fibronectin versus soluble fms-like tyrosine kinase/placental growth factor ratio testing for the assessment of pre-eclampsia: protocol for a multicentre... by Marcus Green, Chao Wang, Sarah Fisher, Amarnath Bhide, Ramesh Ganapathy, Basky Thilaganathan, Nouran Elbarbary

“…Maternal and neonatal outcome data will be collected to compare the sensitivity and specificity of the tests, with the primary outcome being delivery for pre-eclampsia within 4 weeks.Ethics and dissemination Ethical approval has been obtained from the Health Research Authority and Health and Care Research Wales Ethics Committee. …”
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Effectiveness of a personal health coaching intervention (diabetescoach) in patients with type 2 diabetes: protocol for an open-label, pragmatic randomised controlled trial by Oliver Faude, Fiona Streckmann, Lukas Zahner, Markus Gerber, Vivien Hohberg, Jan-Niklas Kreppke, Jan Kohl, Eleonora Seelig, Daniel König

“…Linear mixed-effects models will be applied for each outcome variable to analyse the intervention effects.Ethics and dissemination This study was approved by the Ethics Committee North-western and Central Switzerland in February 2021 (ref: 2020-02755). …”
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Modular-based psychotherapy (MoBa) versus cognitive–behavioural therapy (CBT) for patients with depression, comorbidities and a history of childhood maltreatment: study protocol fo... by Elisabeth Schramm, Martin Hautzinger, Carolin Jenkner, Moritz Elsaesser, Sabine Herpertz, Hannah Piosczyk

“…Crucial feasibility aspects include targeted psychopathological mechanisms, selection (treatment algorithm), sequence and application of modules, as well as training and supervision of the study therapists.Ethics and dissemination This study obtained approval from the independent Ethics Committees of the University of Freiburg and the University of Heidelberg. …”
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Transformasi Layanan Pendidikan di MTs Swasta Batang Barat: Peran Komunikasi, Kompetensi, dan Etos Kerja Guru by Arif Slamet Saputro, Nurkholis Nurkholis, Ghufron Abdullah

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Spectrum of Cytopathological Causes of Cervical Lymphadenopathy- An Experience at Sahiwal Teaching Hospital by Raees Abbas Lail, Areeba Farooq, Qurrat-ul-Ain Tahir, Sadaf Shafique, Syeda Tooba Fatmi, Abdul Ghaffar

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Accuracy of the combined method (auscultation and pH measurement) and ultrasonography for confirmation of gastric tube placement: a study protocol for a prospective study by Fernanda Raphael Escobar Gimenes, Rosana Aparecida Pereira, Mayara Carvalho Godinho Rigobello, Jorge Elias Junior, Carlos Alberto Grespan Bonacim, Renata Cristina de Campos Pereira Silveira, Fernanda Caroline Bonardi, Roosevelt Santos Nunes

“…The combined method and the ultrasound will be the index tests and will be performed on all study participants for later comparison with an X-ray examination, considered the reference standard and the gold standard to distinguish between gastric and pulmonary placement. …”
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Comprehensive self-tracking of blood glucose and lifestyle with a mobile application in the management of gestational diabetes: a study protocol for a randomised controlled trial (... by Henri Vähä-Ypyä, Harri Sievänen, Seppo Heinonen, Sari Niinistö, Suvi M Virtanen, Ilkka Korhonen, Mikko Kytö, Lisa Torsdatter Markussen, Pekka Marttinen, Giulio Jacucci, Tuuli E Korhonen, Saila B Koivusalo

“…The intervention group receives standard antenatal care and the eMOM GDM app, while the control group will receive only standard care. …”
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Use of virtual reality in port implantation to reduce perioperative anxiety and pain: protocol for a randomised controlled pilot trial at a single German university hospital (VIP-t... by Christoph W Michalski, Felix J Hüttner, Colette Dörr-Harim, Sandra Graf, Hannah Feldmann, Lisa S Hunold, Kira C Steinkraus, Nadir Nasir

“…Further outcomes include patient satisfaction and tolerability, perioperative analgesia and sedation, occurrence of postoperative nausea, vomiting and VR sickness symptoms, surgeon’s satisfaction, procedure duration, postoperative complications until postoperative day 30 and patient willingness to hypothetically undergo port implantation again under the same conditions.Ethics and dissemination The VIP trial has been approved by the Ethics Committee of the Medical Faculty of Ulm University (reference number 03/22). …”
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Association of Breastfeeding with Non-Alcoholic Fatty Liver Disease and Non-Alcoholic Steatohepatitis in mothers: A cross sectional survey by Muhammad Zafar Majeed Babar, Ghulam Mustafa, Manzur Ahmad Manzur, Hafiz Haseeb Ahsan

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