Multilevel determinants of racial/ethnic disparities in severe maternal morbidity and mortality in the context of the COVID-19 pandemic in the USA: protocol for a concurrent triang... by Bankole Olatosi, Jiajia Zhang, Xiaoming Li, Chen Liang, Jihong Liu, Peiyin Hung, Shan Qiao, Berry A Campbell, Myriam E Torres, Neset Hikmet

“…We will use a convergent parallel design which includes a quantitative analysis of data from the 2018–2021 SC Pregnancy Risk Assessment and Monitoring System (unweighted n>2000) and in-depth interviews of 40 postpartum women and 10 maternal care providers to identify distinct mediating pathways.Ethics and dissemination The study was approved by institutional review boards at the University of SC (Pro00115169) and the SC Department of Health and Environmental Control (DHEC IRB.21-030). Informed consent will be provided by the participants in the in-depth interviews. …”
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Efficacy of Chinese traditional quadruple single pill combination versus valsartan/hydrochlorothiazide for the treatment of hypertension (COSPQ-BP): study protocol for randomised c... by Kai Liu, Yu Yan, Xin Zhang, Yanan Li, Yuanyuan Yao, Lu Liu, Runyu Ye, Si Wang, Xiangyu Yang, Xiaoping Chen, Shanshan Jia, Qingtao Meng, Xianghao Zuo

“…The secondary outcomes have been predetermined and will primarily encompass the following: (1) changes in other BP measures, as well as changes in blood lipids, blood glucose and uric acid at 12 weeks and (2) evaluation of the impact of starting antihypertensive therapy with compound reserpine and triamterene tablets or valsartan/hydrochlorothiazide on the depressive and anxiety statess of patients.Ethics and dissemination The study protocol (version number: V5.0, version date: 17 January 2023) has been approved by the ethics committee (Biomedical Ethics Committee of West China Hospital of Sichuan University, approval number: Review (51) in 2023). Written informed consent will be obtained from each participant by researchers. …”
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Assessment of awareness of keratoconus and its relation to eye rubbing among Saudi Arabia population by Nuwayyir Abdullah Alqasimi, Lujain Hatim Aljohani, Renato Ambrósio, Renato Ambrósio, Renato Ambrósio, Renato Ambrósio, Renato Ambrósio, Bader Saad AlQahtani, Bader Saad AlQahtani, Nasser Saleh Al Haydar, Bdour Raja Alanazi, Danah Tariq Alfurayhan, Lina Sami Hussain Saber, Fatemah Saleh Alsalem, Nawaf Abdullah Alqahtani, Jose Manuel Vargas

“…Prior to administering the questionnaire, informed consent was obtained, and the confidentiality of the collected data was ensured.ResultsThis survey had a total of 2,059 respondents. …”
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Comparison of analgesic efficacy of diclofenac suppository with intramuscular diclofenac sodium in post-operative pain relief after cesarean delivery in the first 24 hours by Sidra Khan, Noreen Majeed, Ruqya, Mehreen Mehdi, Faiza Safdar, Saana Bibj

“…Total of 100  antenatal women already planned for elective caesarean section ,who fulfilled inclusion criteria were selected after taking  informed consent & ethical approval by employing non probability consecutive sampling . …”
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Weekend-Based Parent-Group Intervention to Reduce Stress in Parents of Children and Adolescents with Type 1 Diabetes: A Pilot Study by Lucia Ferrito, Barbara Predieri, Dorina Pjetraj, Maria Cristina Alessandrelli, Manuela Pagnini, Antonio Iannilli, Monica Marino, Stefano Tombolini, Basilio Pintaudi, Giuseppe Lucisano, Fabiana Zani, Lorenzo Iughetti, Antonio Nicolucci, Valentino Cherubini

“…The study was approved by EC and participants filled a consent form. At baseline and after intervention, parents filled in a questionnaire including Diabetes-Related Distress (DRD), Parent Health Locus of Control Scale (PHLOC), Parent Stress Index Short Form (PSI-SF), Hypoglycemia Fear Survey-Parents (HFS-P) and Hypoglycemia Fear Survey-Parents of Young Children (HFS-P-YC), and Health Survey Short Form-36 (SF-36). …”
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Země Koruny české a Svatá říše římská v raném novověku by Petr Vorel

“…The exclusion of the Bohemia Crown from the empire took place under mutual consent and as a purely diplomatic event; therefore, it did not stir up any conflict of power (unlike in Switzerland). …”
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Evaluation of musculoskeletal complaints, treatment approaches, and patient perceptions in family medicine clinics in a tertiary center in Jordan: a cross-sectional study by Moh’d S. Dawod, Mohammad N. Alswerki, Ahmad F. Alelaumi, Jehad Feras AlSamhori, Rana J. Rahhal, Lina Khraisat, Eman Mohammad Arabas, Hussein M. Bdair, Reem M. Alhyari, Mohammad Shahin, Mohammad Abu Hilal, Alaa Y. Akel, Aws Khanfar

“…Ethical approval and informed consent were obtained. Analysis was conducted in SPSS with p < 0.05 as the significance threshold. …”
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An observational, multigenerational platform for health systems and population health interventions to minimise intergenerational transmission of non-communicable diseases in India... by Vaman Khadilkar, Tarun Reddy Katapally, Jasmin Bhawra, Neha Kajale, Rubina Mandlik, Vivek Patwardhan, Demi Miriam, Dipali Ladkat, Chidvilas More, Ketan Gondhalekar, Anuradha Vaman Khadilkar

“…After obtaining informed consent from participants (parents and their children), comprehensive data are being collected from both children and parents, including clinical, behavioural, healthcare access and utilisation, as well as socioeconomic determinants of health. …”
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CHI study: protocol for an observational cohort study on ageing and mental health in community-dwelling older adults by Lei Feng, Lieng Hsi Ling, Qiushi Feng, Rachael Zhi Yi Lee, Junhong Yu, Iris Rawtaer, Patrick Finbarr Allen, Zhiming Bao, Jeong Kyu Lee, Chin Tat Lim, Leng Leng Thang, Thet Naing, D Y Wang, Kai Zhen Yap, EH Kua, Rathi Mahendran

“…Results from the cohort will enable future studies to identify at-risk groups and develop interventions to improve the physical and mental health and quality of life of older adults.Ethics and dissemination Approval of the cohort study by the National University of Singapore Institutional Review Board (NUS-IRB Reference code: H-17-047) was obtained on 12 October 2017. Written consent will be obtained from all participants. Findings from the cohort study will be disseminated by publication of peer-reviewed manuscripts, presentations at scientific meetings and conferences with local stakeholders.…”
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Prevalence and Risk Factors of Helicobacter pylori Infection among Children Aged 1 to 15 Years at Holy Innocents Children’s Hospital, Mbarara, South Western Uganda by Phoebe Aitila, Michael Mutyaba, Simon Okeny, Maurice Ndawula Kasule, Rashid Kasule, Frank Ssedyabane, Benson Okongo, Richard Onyuthi Apecu, Enoch Muwanguzi, Caesar Oyet

“…After obtaining informed consent from parents/legal guardians, illegible children who presented with gastrointestinal complaints at Holy Innocents Children’s Hospital were recruited; structured questionnaires were administered to the parents/guardians to collect information on sociodemographic data and risk factors of H. pylori infection. …”
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Genetic counselling in the era of next generation sequencing by Diego Espada-Musitu, África Manero-Azua, Yerai Vado, Guiomar Perez de Nanclares

“…The ethical implications of parents giving consent to genetic testing in their offspring and the potential disclosure of genetic diseases for which there are limited therapeutic options are still under debate. …”
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The Public Health Service “Increased Risk” 2020 Policy Change Has not Improved Organ Utilization in the United States: A Nationwide Cohort Study by Dane C. Paneitz, MD, MPH, Stanley B. Wolfe, MD, MPH, Duc Giao, BA, Shannon N. Tessier, PhD, Leigh Anne Dageforde, MD, MPH, Nahel Elias, MD, Seyed Alireza Rabi, MD, PHD, Eriberto Michel, MD, David A. D’Alessandro, MD, Asishana A. Osho, MD, MPH

“…Recently, the PHS provided an updated guideline focused on “Increased Risk” organ donors, which included the removal of the “Increased Risk” label and the elimination of the separate informed consent form, although the actual increased risk status of donors is still ultimately transmitted to transplant physicians. …”
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Resurgence of Mumps among Lower Socioeconomic Class of Children in Ahmedabad: A Cross-sectional Study of 115 Cases in a Tertiary Care Center by Dipti V Patel, Zeel Patel, Snehal V Patel, Pooja Gandhi, Gayatri Parmar, Param S Patel

“…All patients belonged to the lower socioeconomic class of Ahmedabad. Informed consent was obtained from patients' relatives. Detailed history in the form of demographic data, clinical presentation, vaccination status for measles–rubella (MR)/measles–mumps–rubella (MMR), reasons for nonvaccination, and history related to complications. …”
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Challenges and Opportunities for Data Sharing Related to Artificial Intelligence Tools in Health Care in Low- and Middle-Income Countries: Systematic Review and Case Study From Tha... by Aprajita Kaushik, Capucine Barcellona, Nikita Kanumoory Mandyam, Si Ying Tan, Jasper Tromp

“…Key solutions included building a conducive digital ecosystem—having shared data input platforms for health facilities to ensure data uniformity and to develop easy-to-understand consent forms, having standardized guidelines for data sharing, and having compensation policies for data breach victims. …”
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Uptake and 4-week outcomes of an ‘opt-out’ smoking cessation referral strategy in a London-based lung cancer screening setting by Anthony Edey, Neal Navani, Kitty Chan, Graham Robinson, Janine Zylstra, Paul Robinson, Laura Green, Anand Devaraj, Jane Rowlands, Allan Hackshaw, Carolyn Horst, Arjun Nair, Sam M Janes, Kate Davies, Jeannie Eng, Mamta Ruparel, Samantha L Quaife, Jennifer L Dickson, Magali Taylor, Angshu Bhowmik, Hasti Robbie, Joseph Jacob, Laura Farrelly, Sophie Tisi, Tanya Patrick, Andrew Creamer, Helen Hall, Samanjit Hare, Jon Teague, Samuel M Janes, Esther Arthur-Darkwa, Thea Buchan, Stephen Ellis, Thomas Callender, Rachael Sarpong, John McCabe, Zaheer Mangera, Ethaar El-Emir, Terry O'Shaughnessy, Geoff Bellingan, Nick Screaton, Priyam Verghese, William M Ricketts, Vicky Bowyer, Kylie Gyertson, Fanta Bojang, Claire Levermore, Tania Anastasiadis, Ruth Prendecki, Amyn Bhamani, Malavika Suresh, Judy Airebamen, Alice Cotton, Kaylene Phua, Elodie Murali, Simranjit Mehta, Karen Parry-Billings, Columbus Ife, April Neville, Zahra Hanif, Helen Kiconco, Ricardo McEwen, Dominique Arancon, Nicholas Beech, Derya Ovayolu, Christine Hosein, Sylvia Patricia Enes, Qin April Neville, Aashna Samson, Urja Patel, Fahmida Hoque, Hina Pervez, Sofia Nnorom, Moksud Miah, Julian McKee, Mark Clark, Anant Patel, Sara Lock, Rajesh Banka, Ugo Ekeowa, Charlotte Cash, Tunku Aziz, Alberto Villanueva, Elena Stefan, Charlie Sayer, Navinah Nundlall, Andrew Crossingham, Tanita Limani, Kate Gowers, Andrew Perugia, James Rusius, Anne-Marie Hacker, Monica L Mullin, Evangelos Katsampouris, Chuen R Khaw, Chuen Khaw, Sheetal Karavadra, Alan Shaw, Chris Valerio, Ali Mohammed, Lynsey Gallagher, Mehran Azimbagirad, Burcu Ozaltin, Maureen Browne, Eleanor Hellier, Catherine Nestor

“…Aggregate data on referral outcomes were obtained from each SSS individually.Results 33.7% (n=2090/6203) of individuals currently smoking tobacco consented to a practitioner-made ‘opt-out’ smoking cessation referral. 42.7% (n=893/2090) of these individuals resided in boroughs where SSS were not present or required self-referral. …”
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Preliminary effectiveness of social prescription and virtual patient information in increasing tertiary prevention among cancer patients (ESPRIT): protocol for a single-centre, ran... by Karen Steindorf, Michael Koller, Michael Leitzmann, Wolfgang Herr, Daniel Heudobler, Lisa Boyer, Anne Herrmann, Tobias Pukrop, Christine Bernardi, Sabine Einhell

“…Signed written informed consent is required from all study participants. The results of the study will be used to inform the power calculation for future confirmatory trials and will be submitted for publication.Trial registration number DRKS00033771.…”
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Asymptomatic Malaria Infection and Hidden Parasitic Burden in Gabonese Schoolchildren: Unveiling Silent Co-Infections in Rural and Urban Settings by Patrice Makouloutou-Nzassi, Lady Charlene Kouna, Chérone Nancy Mbani Mpega Ntigui, Neil Michel Longo-Pendy, Judy Armel Bourobou Bourobou, Felicien Bangueboussa, Nick Chenis Atiga, Jean Bernard Lekana-Douki, Larson Boundenga, Sandrine Lydie Oyegue-Liabagui

“…Blood and stool samples were collected from participants whose parents or legal guardians provided informed consent to participate in the study. Hemoglobin concentration (Hb) was measured using a HemoCue photometer (HemoCue 201, HemoCue, Angelholm, Sweden). …”
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Smart phone-based transcutaneous electrical acupoint stimulation as adjunctive therapy for hypertension (STAT-H trial): protocol for a cluster randomised controlled trial by Yu Wang, Xiao Wang, Ying Lin, Chao-Qun Yan, Guang-Xia Shi, Cun-Zhi Liu, Jing-Wen Yang, Jian-Feng Tu, Shi-Yan Yan, Xin-Tong Su, Li-Qiong Wang, Si-Bo Kang, Bao-Hong Mi, He-Wen Li, Xue-Zhou Wang

“…Safety outcomes will be any serious adverse events and clinical events.Ethics and dissemination This study has been approved by ethics committee of Beijing University of Chinese Medicine (No. 2020BZHYLL0104). Written informed consent will be obtained from all patients before randomisation. …”
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Prospective study of factors associated with asthma attack recurrence (ATTACK) in children from three Ecuadorian cities during COVID-19: a study protocol by Cristina Ardura-Garcia, Max Bachmann, Alejandro Rodriguez, Philip Cooper, Michael Richard Perkin, Irina Chis Ster, Natalia Cristina Romero, Martha E Chico, Alvaro Cruz, Diana Morillo, Santiago Mena-Bucheli, Angélica Ochoa, Claudia Rodas, Augusto Maldonado, Karen Arteaga, Jessica Alchundia, Karla Solorzano, Camila Figueiredo

“…Participants gave informed consent to participate in the study before taking part.…”
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Mesotherapy: From Historical Notes to Scientific Evidence and Future Prospects by Massimo Mammucari, Enrica Maggiori, Domenico Russo, Chiara Giorgio, Gianpaolo Ronconi, Paola E Ferrara, Flora Canzona, Luciano Antonaci, Bartolomeo Violo, Renato Vellucci, Domenico Rocco Mediati, Alberto Migliore, Umberto Massafra, Barbara Bifarini, Fabio Gori, Massimo di Carlo, Stefano Brauneis, Teresa Paolucci, Piergiovanni Rocchi, Anna Cuguttu, Raffaele Di Marzo, Alessandro Bomprezzi, Stefania Santini, Manuela Giardini, Anna Rosa Catizzone, Fiammetta Troili, Dario Dorato, Alessandra Gallo, Costanza Guglielmo, Silvia Natoli

“…Despite the lack of randomized clinical trials in some fields of application, a general consensus is also reached in nonpharmacological mechanism of action, the technique execution modalities, the scientific rationale to apply it in some indications, and the usefulness of the informed consent. The Italian Mesotherapy Society proposes this position paper to apply intradermal therapy based on scientific evidence and no longer on personal bias.…”
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