mHealth intervention (mTB-Tobacco) for smoking cessation in people with drug-sensitive pulmonary tuberculosis in Bangladesh and Pakistan: protocol for an adaptive design, cluster r... by Rumana Huque, John Norrie, Kamran Siddiqi, Melanie Boeckmann, Mahmoud Danaee, Ai Keow Lim, Steve Parrott, Amina Khan, Saeed Ansaari, Maham Zahid, Fahmidur Rahman, Asiful Chowdhury, Shakhawat Hossain Rana

“…Cost-effectiveness analysis will be done to estimate the cost per quitter and cost per quality-adjusted life year gained, calculate the incremental cost-effectiveness ratios to establish the value for money for mTB-Tobacco.Ethics and dissemination This trial will be conducted in compliance with International Council on Harmonisation - Good Clinical Practice guidelines and the Declaration of Helsinki. …”
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Phase I/II trial of intracerebral transplantation of autologous bone marrow stem cells combined with recombinant peptide scaffold for patients with chronic intracerebral haemorrhag... by Arisa Miura, Yoichi M Ito, Masahito Kawabori, Miki Fujimura, Kaoru Kahata, Hideo Shichinohe, Kenichiro Maeda, Masahiko Mukaino, Ryo Kogawa, Kentaro Nakamura, Shuho Gotoh, Kota Kurisu

“…Neurological assessments, MRI, 18F-fluorodeoxyglucose positron emission tomography and 123I-Iomazenil single-photon emission CT will be performed for 1 year after administration.Ethics and dissemination The trial protocols were reviewed and approved by the Institutional Review Board of the Hokkaido University Hospital (R5-11), and this study is conducted according to Good Clinical Practice guidelines and the principles of the Declaration of Helsinki. …”
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Radiomics in the differential diagnosis of glioblastoma under the primary neurooncoimaging conditions by Nikita E. Maslov, Daria A. Valenkova, Alexander M. Sinitсa, Gennadiy E. Trufanov, Vladimir M. Moiseenko, Alexander Yu. Efimtsev, Vera V. Chernobrivtseva

“…According to the 2021 WHO Classification of Tumors of the Central Nervous System (CNS) and the 2023 Clinical Practice Guidelines on the Drug Management of Primary CNS Cancers, the first step of molecular genetic testing to identify the morphological type and malignancy of adult-type diffuse gliomas is the detection of isocitrate dehydrogenase (IDH) mutation status. …”
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Novel Versus Conventional Sequencing of β-Blockers, Sodium/Glucose Cotransportor 2 Inhibitors, Angiotensin Receptor-Neprilysin Inhibitors, and Mineralocorticoid Receptor Antagonist... by Sumanth Karamchand, Tsungai Chipamaunga, Poobalan Naidoo, Kiolan Naidoo, Virendra Rambiritch, Kevin Ho, Robert Chilton, Kyle McMahon, Rory Leisegang, Hellmuth Weich, Karim Hassan

“…ConclusionsWe envisage that this study will help support evidence-based medicine and inform clinical practice guidelines on the optimal rate of sequencing of anti–heart failure therapies. …”
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Progestogens in women with threatened miscarriage or recurrent miscarriage: A meta‐analysis by Yunli Zhao, Rohan D'Souza, Ya Gao, Qiukui Hao, Lucas Kallas‐Silva, Jeremy P. Steen, Gordon Guyatt

“…Abstract Introduction Clinical practice guidelines provide inconsistent recommendations regarding progestogen supplementation for threatened and recurrent miscarriage. …”
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Correlation of polymorphous variants (ApaI, TagI, BsmI) of the VDR receptor gene with the vitamin D level and liver fibrosis in children with autoimmune hepatitis by V. S. Berezenko, Kh. Z. Mykhailiuk, Z. I. Rossokha, S. P. Kyriachenko

“…In all children, the diagnosis was confirmed in accordance with the International Guidelines for the study of liver diseases (European Association for the Study of Liver (EASL) Clinical Practice Guidelines: Autoimmune Hepatitis, 2015). In the examined children, the elastography of the liver parenchyma was performed by the shear wave method. …”
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Evaluation of the Glucose-Lowering Effect of Bloodletting Therapy in Type 2 Diabetes Mellitus by Tserentogtokh Baasantogtokh, Sainbileg Sonomtseren, Tsolmon Unurjargal, Rinchyenkhand Myagmardorj, Vaanchigsuren Seesregdorj, Bayarmagnai Lkhagvasuren, Vankhuu Enkhtuya, Seesregdorj Surenjid

“…Both groups received medicine according to the Mongolian Clinical Practice Guidelines for T2DM treatment. The experimental group additionally underwent bloodletting therapy on Day 6 of the study, following a 5-day preparation period during which they consumed 2.0 grams of a “3-seed decoction” (twice daily). …”
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A pharmacist-led educational and audit & feedback strategy to reduce antibiotic prescription in primary care: the AFA study by A. Soler, A. Huguet, A. Leiva, C. Vicens, F. Bejarano-Romero, E. Sempere, T. Izquierdo, M. M. Parera, R. Seco, M. Fages, A. Medina, L. Castillo-Palomares, E. López-Guerrero, B. A. Ferrer, L. Ugarriza, M. Llarena, L. Gallardo-Alfaro, AFA study investigators

“…Ethics and dissemination The study was approved by the Balearic island, Valencia and IDIAP Jordi Gol Ethical Committee, follows the Declaration of Helsinki, Good Clinical Practice guidelines, and applicable national and European regulations concerning clinical trials and data protection. …”
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Analysis of the Consumption of Medicinal Products Associated with a High Risk of Drug-Induced Liver Injury in Patients with COVID-19 by V. I. Petrov, A. Yu. Ryazanova, N. S. Tokareva

“…The authors identified medicines capable of causing clinically apparent liver damage (according to the LiverTox database and Russian clinical practice guidelines) and/or elevated liver enzymes in ≥1% of patients (according to safety reports).RESULTS. …”
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Prospects for the Use of NGAL and KIM-1 for the Diagnosis of Acute Kidney Injury in Patients Receiving Antibacterial Therapy by E. Yu. Nikitin, V. N. Drozdov, M. A. Vyzhigina, O. A. Vorobieva, A. A. Astapovskiy, K. N. Khalaidzheva, E. V. Shikh

“…The developers of Clinical Practice Guidelines for Acute Kidney Injury titled The Initiative to Improve Global Kidney Disease Outcomes (KDIGO) point at the need of new biomarkers for diagnosis acute kidney injury (AKI).The objective: to study and evaluate the diagnostic significance of the levels of neutrophil gelatinase-associated lipocalin (NGAL) and kidney injury molecule-1 (KIM-1) in patients with AKI in the early postoperative period when antibiotic therapy is used.Subjects and Methods. …”
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Osteonecrosis of the jaw in patients with clear cell renal cell carcinoma treated with targeted agents: a case series and large-scale pharmacovigilance analysis by Shuyun Wang, Shuyun Wang, Rui Zhang, Song Wang, Qian Guo, Qian Guo, Donghong Yin, Yan Song, Xianhua She, Xuyan Wang, Jinju Duan

“…TKIs and ICIs are limited to drugs that treat renal cancer recommended by the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology for Kidney Cancer.MethodsWe described a case series of patients experiencing ONJ while on TKIs or ICIs. …”
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Proportion and clinical characteristics of metabolic-associated fatty liver disease and associated liver fibrosis in an urban Chinese population by Mengmeng Hou, Qi Gu, Jiawei Cui, Yao Dou, Xiuhong Huang, Jie Li, Liang Qiao, Yuemin Nan, Yuanyuan Ji

“…The diagnosis of MAFLD was based on the established clinical practice guidelines. The fibrosis-4 index score (FIB-4) was employed to evaluate hepatic fibrosis, with a FIB-4 score of ≥1.3 indicating significant fibrosis. …”
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‘Effects of a home-based bimodal lifestyle intervention in frail patients with end-stage liver disease awaiting orthotopic liver transplantation’: study protocol of a non-randomise... by Hans Blokzijl, Vincent E de Meijer, Rienk Dekker, Joost M Klaase, Coby Annema, Bart C Bongers, Allard G Wijma, Job AM van der Palen, Frans JC Cuperus

“…Finally, feasibility of the programme will be assessed by monitoring the participation rate and reasons for non-participation, number and severity of adverse events, and dropout rate and reasons for dropout.Ethics and dissemination This study was approved by the Medical Research Ethics Committee of the UMCG (registration number NL83612.042.23, August 2023) and is registered in the Clinicaltrials.gov register (NCT05853484). Good Clinical Practice guidelines and the principles of the Declaration of Helsinki will be applied. …”
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Protocol for a multicentre, randomised, parallel-control, superiority trial comparing administration of clotting factor concentrates with a standard massive haemorrhage protocol in... by Neil Parry, Andrew Beckett, Jo Carroll, Homer Tien, Jeannie Callum, Andrew Petrosoniak, Damon Scales, Luis Teodoro da Luz, Keyvan Karkouti, Paul T Engels, Hans-Peter Hucke, Deep Grewal, Bruce Schwartz, Henry Peng

“…After enrolment of 120 patients, a preplanned adaptive interim analysis will be conducted to reassess assumptions, check for early superiority demonstration or reassess the sample size for remainder of the study.Ethics and dissemination The study has been approved by local and provincial research ethics boards and will be conducted according to the Declaration of Helsinki, Good Clinical Practice guidelines and regulatory requirements. As per the Tri-Council Policy Statement, patient consent will be deferred due to the emergency nature of the interventions. …”
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The Role of Cardiac Computed Tomography Angiography in Risk Stratification for Coronary Artery Disease by Sophie E. van Rosendael, MD, PhD, Arthur Shiyovich, MD, Rhanderson N. Cardoso, MD, Camila Veronica Souza Freire, MD, Alexander R. van Rosendael, MD, PhD, Fay Y. Lin, MD, Gina Larocca, MD, Solomon W. Bienstock, MD, Ron Blankstein, MD, Leslee J. Shaw, PhD

“…Along with these technological advancements, there has been additional high-quality evidence for CCTA including large randomized clinical trials supporting high-level recommendations from many international clinical practice guidelines. Current trials largely compare a CCTA vs functional testing strategy, yet there is minimal evidence on CCTA plaque-guided therapeutic trials to measure regression of atherosclerosis and prevention of major coronary artery disease events. …”
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Validation of a questionnaire to assess complexity of palliative care needs in primary care in Malaga, Spain: a study protocol by Jose Miguel Morales-Asencio, Rafael Gomez-Garcia, Pilar Barnestein-Fonseca, Francisca Leiva-Fernandez, Auxiliadora Fernández-López, Maria Luisa Martín-Roselló, Virginia Patricia Aguiar-Leiva

“…This protocol was conducted without patient or public participation.Ethics and dissemination This study evaluates a novel, co-designed tool to diagnose PC complexity to inform practice recommendations for a more efficient allocation of resources that may be included in future clinical practice guidelines. The study has been approved by the Provincial Research Ethics Committee of Málaga as of July 2023 and will be conducted in accordance with the principles established in the Declaration of Helsinki, the Council of Europe Convention on Human Rights and Biomedicine, and the requirements established in Spanish legislation. …”
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Evidence gaps in conservative non-pharmacological interventions and guideline implementation for high-burden non-communicable diseases: protocol for an overview of reviews by Tobias Braun, Patrick J Owen, Daniel L Belavy, Christian Kopkow, Toni Lange, Tobias Saueressig, Rilind Shala, Jochen Zebisch, Kerstin Lüdtke, Andres Jung, Katja Ehrenbrusthoff, Rebekka Döding, Bernhard Elsner, Clint Miller, Axel Schäfer, Robin Schäfer, Tim Schleimer, Tibor Szikszay

“…Eligible interventions will encompass conservative non-pharmacological approaches recommended by clinical practice guidelines (ie, physical, psychological and education/advice). …”
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Web-Based Human Papillomavirus Education and Professional Skills Intervention for Health Care Providers: Protocol for a Randomized Controlled Trial by Jacob Martinez, Jacquelin I Cordero, Meagan Whitney, Katie L LaRoche, Gabriel Frietze, Eva M Moya, Kristin Gosselink

“…Tailored web-based educational programs for health care professionals, designed to address regional and patient population characteristics, may be a promising approach to enhancing the real-world implementation of clinical practice guidelines. Trial RegistrationClinicalTrials.gov NCT05120869; http://clinicaltrials.gov/ct2/show/NCT05120869 International Registered Report Identifier (IRRID)PRR1-10.2196/60790…”
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Seizure prophylaxis following aneurysmal subarachnoid haemorrhage (SPSAH): study protocol for a multicentre randomised placebo-controlled trial of short-term sodium valproate proph... by Qiaowei Wu, Yuqi Chen, Chao You, Yuchen Li, Bowen Sun, Jianmin Zhang, Xin Hu, Pei Wu, Mei Fang, Zhiyi Xie, Honggang Wu, Shancai Xu, Bo Pang, Niandong Zheng

“…All analyses are by intention-to-treat.Ethics and dissemination This study will be conducted according to the principles of Declaration of Helsinki and good clinical practice guidelines. This trial involves human participants and has been approved by the ethics committee of West China Hospital. …”
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Recommendations for the management of functional dyspepsia from the SEGHNP working group on motility and functional gastrointestinal disorders by Miguel Ángel Carro Rodríguez, Inmaculada Hidalgo Montes, Carmen Jovani Casano, Aránzazu Recio Linares, Etna Masip Simó, Gloria Rodrigo Garcia, Andrés Bodas Pinedo

“…As a result, there is evidence of substantial heterogeneity in the management of these patients due, in part, to the absence of clinical practice guidelines on this disease. Material and methods: A group was formed that consisted of 19 members of the working group on motility and functional gastrointestinal disorders (FGIDS) of the SEGHNP. …”
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