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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Investigating a caregiver-assisted social skills group programme for primary and early high school-aged children with acquired brain injury or cerebral palsy: protocol for a pilot... by Koa Whittingham, Roslyn N Boyd, Rose Gilmore, Leanne Sakzewski, Nicola Hilton, Afroz Keramat, Bianca Thompson, Jacqui Barfoot, Christine T Moody

“…Recruitment and participant informed consent process will be completed in accordance with institutional ethic procedures. …”
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Evaluation of outcome relevance of quality indicators in the emergency department (ENQuIRE): study protocol for a prospective multicentre cohort study by Anna Slagman, Felix Greiner, Martin Möckel, Rainer Röhrig, Susanne Drynda, Wencke Schindler, Johannes Pollmanns, Dirk Horenkamp-Sonntag, Wiebke Schirrmeister, Ronny Otto, Jonas Bienzeisler, Saskia Drösler, Rolf Lefering, Jennifer Hitzek, Enno Swart, Felix Walcher

“…Included are all patients in 2019, who were ≥18 years of age, insured at the Techniker Krankenkasse (statutory health insurance (SHI)) and gave their written informed consent to the study.The primary objective of the study is to assess the effect of selected quality measures on patient outcome. …”
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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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Do continuous glucose monitoring (CGM) metrics predict macrovascular and microvascular complications in diabetes? The FACULTY protocol of a retrospective real-world cohort study by Eric Vicaut, Ramzi A Ajjan, J Seufert, Gérard de Pouvourville, Emmanuel Cosson, Laure Carcaillon-Bentata, Tadej Battelino, Patrick Blin, Fleur Levrat-Guillen, Michael Joubert

“…This study uses pseudonymous information, not requiring informed consent. Dissemination plans include full publication of the study outcomes in peer-reviewed journal(s) with open access and presentations at national and international diabetes and cardiovascular conferences.…”
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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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Anaemia prevalence in children newly registered at UNRWA schools: a cross-sectional study by Yassir Turki, Wafaa Zeidan, Akihiro Seita, Majed Hababeh, Nada AbuKishk, Suha Saleh, Shatha Albaik, Zoheir el-Khatib, Nimer Kassim, Hasan Arab, Khawalah Abu-Diab

“…Boys and girls living inside or outside Palestine refugee camps were included. Verbal consent was obtained from their parents.Primary and secondary outcome measures Sociodemographic and anthropometric data on each child were collected. …”
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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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Developing an adaptive paediatric intensive care unit platform trial with key stakeholders: a qualitative study by Kerry Woolfall, Mark J Peters, Padmanabhan Ramnarayan, Elizabeth Deja, Jennifer Preston, Paul R Mouncey, Julie C Menzies, Doug William Gould, Tracy Karen Mitchell, Shelley Marsh, Jennifer Ainsworth, Hannah Sedgwick, Carly Tibbins

“…Participants viewed the proposed PICU platform trial and use of research without prior consent to be acceptable. Findings provide insight into how the PICU platform trial should be designed and operationalised, including having a broad and inclusive population eligible for inclusion onto the platform trial, with different inclusion and exclusion criteria for each domain; starting the trial with no more than three domains and prioritising the outcomes of Child quality of life and Survival (all participants). …”
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Sex, Knowledge, and Attitude of Stroke Survivors Attending Bebe Herbal Center on Risk Factors before and after Stroke by Polycarp U. Nwoha, Florence O. Okoro, Emmanuel C. Nwoha, Fidelia N. Chukwu, Chidinma O. Nwoha, Nkeiru C. Ogoko, Peace N. Nwoha, Chika A. Idaguko, Augustine U. Obi, Ezenna M. Agwu, Iyanu O. Ayoola, Sunday O. Osonwa, Ifeoma H. Okpara

“…This was a cross-sectional study conducted from January to June 2018 at Bebe Herbal Center, and it involved two well-trained assistants who interviewed 149 first-time stroke survivors after consent and ethical approval were obtained. The survivors self-reported their knowledge, attitude, and beliefs on risk factors before and after stroke. …”
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Genetic-epigenetic aspects of infertility in women with long-COVID-19 by O.G. Boichuk, I.S. Golovchak, T.V. Kolomiichenko

“…The research protocol was approved by the Local Ethics Committee of the institution mentioned in the work. Informed consent of the women was obtained for the research. …”
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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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