title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
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Data Availability | The datasets generated and/or analysed during the current study are available from the corresponding author on reasonable request. | PMC10173559 | ||
Declarations | PMC10173559 | |||
Competing interests | The authors declare that they have no competing interests | PMC10173559 | ||
Ethics approval and consent to participate | This study was reviewed and approved by the Makerere University School of Public Health’s Research and Ethics Committee (Protocol #: 825) and cleared by the Uganda National Council for Science and Technology (UNCST). All participants provided written informed consent prior to participation in the study. All study proce... | PMC10173559 | ||
Consent for publication | Not applicable. | PMC10173559 | ||
References | PMC10173559 | |||
Subject terms | PD-L1-positive esophageal squamous cell carcinoma, ESCC | OESOPHAGEAL SQUAMOUS CELL CARCINOMA | First-line systemic therapeutic options for advanced esophageal squamous cell carcinoma (ESCC) are limited. In this multicenter, double-blind phase 3 trial, a total of 551 patients with previously untreated, locally advanced or metastatic ESCC and PD-L1 combined positive score of ≥1 were randomized (2:1) to receive ser... | PMC9941045 |
Main | esophageal cancer, death, ESCC | OESOPHAGEAL CANCER, ESOPHAGEAL SQUAMOUS CELL CARCINOMA | Esophageal squamous cell carcinoma (ESCC) is the predominant histological subtype of esophageal cancer and accounts for approximately 84% of all esophageal cancer casesSystemic chemotherapy remains the backbone of treatment of unresectable or metastatic ESCC. Although 5-fluorouracil (5-FU) or paclitaxel plus cisplatin ... | PMC9941045 |
Results | PMC9941045 | |||
Patients and treatment | A total of 976 patients were screened between 19 June 2019 and 17 December 2021, and 551 of them were randomly assigned to serplulimab plus chemotherapy ( | PMC9941045 | ||
Efficacy | DISEASE PROGRESSION | At the data cutoff date, 219 (60%) patients in the serplulimab plus chemotherapy group and 129 (70%) in the placebo plus chemotherapy group had disease progression or had died. At the time of this final PFS analysis, serplulimab plus chemotherapy met the criteria for superiority in prolonging PFS over placebo plus chem... | PMC9941045 | |
Discussion | esophageal cancer, tumor, death, ESCC, treatment-related adverse | TUMOR, OESOPHAGEAL CANCER, ADVERSE EVENTS, SOLID TUMORS, MICROSATELLITE INSTABILITY, SECONDARY, LUNG METASTASES, CPS, METASTASES | In this double-blind, placebo-controlled, randomized phase 3 study, we evaluated the efficacy and safety of first-line serplulimab plus chemotherapy versus placebo plus chemotherapy in patients with locally advanced or metastatic, PD-L1-positive (CPS ≥ 1) ESCC. In our prespecified final analysis for PFS and interim ana... | PMC9941045 |
Methods | PMC9941045 | |||
Ethics statement | Cancer Center/Cancer | The study was performed in accordance with the Declaration of Helsinki and the International Conference on Harmonisation Good Clinical Practice guidelines. The study protocol was approved by the institutional review boards or ethics committees of all participating centers (the ethics committee of the leading clinical c... | PMC9941045 | |
Study design and participants | ASTRUM-007 was a randomized, placebo-controlled, double-blind, phase 3 clinical study conducted at 70 hospitals in China (Supplementary Table | PMC9941045 | ||
Randomization and masking | CPS, DISEASE | Eligible patients were randomly assigned (2:1) using an integrated web response system to receive serplulimab plus chemotherapy or placebo plus chemotherapy. Randomization was stratified by PD-L1 expression level (CPS ≥ 10 versus CPS < 10), age (≥65 years versus <65 years) and disease status (locally advanced versus di... | PMC9941045 | |
Procedures | Cancer | ADVERSE EVENT, ADVERSE EVENT, CANCER | Patients received serplulimab or placebo (3 mg kgTumor imaging was scheduled once every 6 weeks for 48 weeks from randomization and every 12 weeks thereafter. Response was assessed according to RECIST v1.1 by the blinded IRRC and the investigators locally. During follow-up, patients were contacted every 12 weeks to ass... | PMC9941045 |
Outcomes | death | DISEASE PROGRESSION | The dual primary endpoints were PFS (time from randomization to first disease progression or death) assessed by the IRRC in accordance with RECIST v1.1 and OS (time from randomization to death due to any cause). Secondary endpoints included IRRC-assessed PFS using iRECIST | PMC9941045 |
Statistical analysis | REGRESSION, EVENTS | The planned sample size was 540 patients, with 339 PFS events and 388 OS events needed to achieve a power of 80% to show an HR of 0.68 for PFS at a one-sided α level of 0.005 and an HR of 0.73 for OS at a one-sided α level of 0.02 for comparison between the serplulimab plus chemotherapy group and the placebo plus chemo... | PMC9941045 | |
Reporting summary | Further information on research design is available in the | PMC9941045 | ||
Online content | Any methods, additional references, Nature Portfolio reporting summaries, source data, extended data, supplementary information, acknowledgements, peer review information; details of author contributions and competing interests; and statements of data and code availability are available at 10.1038/s41591-022-02179-2. | PMC9941045 | ||
Supplementary information |
Supplementary Table 1, study protocol and statistical analysis plan.Reporting Summary | PMC9941045 | ||
Extended data | PMC9941045 | |||
Extended data | is available for this paper at 10.1038/s41591-022-02179-2. | PMC9941045 | ||
Supplementary information | The online version contains supplementary material available at 10.1038/s41591-022-02179-2. | PMC9941045 | ||
Acknowledgements | This study was funded by Shanghai Henlius Biotech, Inc. We thank the patients, their families and the study personnel involved in this trial. We thank the clinical study team (clinical operations, Lu Luo, Guiyu Yang and Haoyu Yu; statistics, Xiao Qi and Jianchen Cheng) and Wenjie Zhang from Shanghai Henlius Biotech, In... | PMC9941045 | ||
Author contributions | J.H. and Q.W. contributed to the conception, design and planning of the study. All authors contributed to the acquisition of data. B.Z., J.H., Y.S. and Q.W. contributed to the writing of the manuscript, and all authors contributed to critical review and revision of the manuscript. J.H. had full access to all of the dat... | PMC9941045 | ||
Peer review | PMC9941045 | |||
Data availability | huangjingwg@163.com, Cancer | CANCER | All requests for data will be reviewed by the leading clinical site (National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College) and the sponsor (Shanghai Henlius Biotech, Inc) to verify whether the request is subject to any ... | PMC9941045 |
Code availability | No custom code was used for statistical analysis in this study. | PMC9941045 | ||
Competing interests | ONCOLOGY | Y.K., J.L., Q.W. and J.Z. are employees of Shanghai Henlius Biotech, Inc. J.H. has served a consulting or advisory role for Merck Sharp & Dohme Oncology and Roche. All other authors declare no competing interests. | PMC9941045 | |
References | PMC9941045 | |||
Introduction | Edited by: Mrinmoy Sanyal, Stanford University, United StatesReviewed by: Lei Li, Oracle, Australia; Larry Ellingsworth, Novavax, Inc., United States†These authors have contributed equally to this workThe SARS-CoV-2 Omicron variant has become the dominant SARS-CoV-2 variant and exhibits immune escape to current COVID-1... | PMC10585368 | ||
Methods | ADENOVIRUS | We have conducted a non-randomized, open-label and parallel-controlled phase 4 trial to evaluate the magnitude and longevity of immune responses to booster vaccination with intramuscular adenovirus vectored vaccine (Ad5-nCoV), aerosolized Ad5-nCoV, a recombinant protein subunit vaccine (ZF2001) or homologous inactivate... | PMC10585368 | |
Results | SARS-CoV-2-specific mucosal IgA | The aerosolized Ad5-nCoV induced the most robust and long-lasting neutralizing activity against Omicron variant and IFNg T-cell response among all the boosters, with a distinct mucosal immune response. SARS-CoV-2-specific mucosal IgA response was substantially generated in subjects boosted with the aerosolized Ad5-nCoV... | PMC10585368 | |
Discussion | Our findings suggest that aerosolized Ad5-nCoV may provide an efficient alternative in response to the spread of the Omicron BA.4/5 variant. | PMC10585368 | ||
Clinical trial registration | PMC10585368 | |||
Introduction | More than 6.8 million people have died from COVID-19 worldwide since the start of the pandemic (More than 100 countries worldwide have already issued recommendations on booster or additional vaccination (In China, seven COVID-19 vaccines have been authorized for use, including five inactivated vaccines, an adenovirus-v... | PMC10585368 | ||
Materials and methods | PMC10585368 | |||
Study design | This study was a non-randomized, open-label and parallel-controlled phase 4 trial (ChiCTR2200057278). 904 eligible participants were randomly assigned to four groups using computer-generated random numbers in SPSS, to receive one dose of Ad5-nCoV via intramuscular injection (Ad5-nCoV-IM, 5×10 | PMC10585368 | ||
Vaccines | All COVID-19 vaccines in this study were developed based on the SARS-CoV-2 wild-type strain (Wuhan-Hu-1 strain) isolated in December 2019. Ad5-nCoV (Convidecia) is a replication-defective human type 5 adenovirus-vectored vaccine, encoding the full-length Spike gene of the Wuhan-Hu-1 strain (YP_009724390) ( | PMC10585368 | ||
RBD-binding IgG assay | SECONDARY | RBD-binding IgG antibodies in the heat-inactivated human serum samples and the culture supernatant of PBMCs stimulated for 4 days with R848 + IL-2 were detected with an RBD-binding IgG ELISA kit (Beijing, Kewei). Briefly, diluted samples and a reference standard were added in duplicate to rSARS-CoV-2 RBD-precoated well... | PMC10585368 | |
Coronavirus-specific saliva IgA assay | IgA | CORONAVIRUS | Saliva samples were collected by centrifugation after having each subject spit about 2 mL of saliva into a disposable saliva sample collector (HUAXIA Medical Equipment). Coronavirus-specific IgA was tested with a SARS-CoV-2 specific (COVID-19 Coronavirus Panel 2) Mesoscale Discovery (MSD) immunoassay. According to the ... | PMC10585368 |
Pseudotype-based neutralization assays | The generation of SARS-CoV-2 Pseudoviruses was performed using the human immunodeficiency virus (HIV) pseudotyped virus production system (Neutralizing activity in each sample was measured with a serial dilution approach as Nie et al. reported ( | PMC10585368 | ||
RBD-ACE2 competitive binding assay | RBD | VIRUS | The RBD neutralizing antibody against the different SARS-CoV-2 variants was evaluated using a commercial ELISA kit (Vazyme) by a surrogate virus neutralization test (sVNT). Sera are serially diluted by 3-fold from 1:5 to 1:1215 or 1:10935 with horseradish peroxidase-labeled recombinant RBD (HRP-RBD) protein and incubat... | PMC10585368 |
Spike-specific IgG ELISpot assays | Spike-specific IgG ELISpot assays were performed on R848- and IL-2-activated PBMCs with a human IgG ELISpot Kit (Mabtech). Briefly, fresh PBMCs were activated with a mixture of R848 at 1 μg ml | PMC10585368 | ||
IFNγ ELISpot assays | STERILE | IFNγ ELISpot assays were performed with fresh PBMCs and a human IFNγ ELISpot Kit (Mabtech) following the manufacturer’s instructions. Tests were performed in duplicate. The precoated ELISpot plates were washed with sterile PBS and blocked with RPMI 1640 medium containing 10% fetal bovine serum and 1× penicillin–strepto... | PMC10585368 | |
Statistical analysis | All analyses of participant samples were conducted using GraphPad Prism 8.0.2 or SAS 9.4. Levels of antibodies against SARS-CoV-2 are presented as the median concentration or median titer with IQR. Spike-specific IgG spots and IFNγ responses are depicted as the median with IQR. Categorical data were analyzed by the χ | PMC10585368 | ||
Results | PMC10585368 | |||
Baseline characteristics of the participants | In this study, 904 subjects who received two doses of inactivated vaccine 6 months prior were assigned to 4 groups for booster vaccination (Trial profile.Baseline characteristics of the participants.Data are n (%) or median. Seropositivity for neutralizing antibody against SARS-CoV-2 from a subset of participants in ea... | PMC10585368 | ||
SARS-CoV-2-specific serum IgG and mucosal IgA responses | Concentrations of anti-SARS-CoV-2 IgG and IgA antibodies were assessed before and after the boost. (Wild-type SARS-CoV-2 RBD-specific binding antibody responses. The level of saliva IgA at day 0 and 14 after boost was also measured to evaluate the mucosal immune response induced by different vaccines. An obvious increa... | PMC10585368 | ||
Pseudotyped SARS-CoV-2 neutralizing antibody responses | Before booster vaccination, only 6.3%~11.8% of participants had a weak wild-type pseudovirus neutralizing antibody (PNAb) titer. Generation of PNAb against wild-type SARS-CoV-2 was significantly increased after booster vaccination in all groups (Pseudotyped SARS-CoV-2 neutralizing antibody responses. Similar kinetics w... | PMC10585368 | ||
SARS-COV-2 surrogate virus neutralization antibody response | The breadth and magnitude of neutralizing antibody responses to various SARS-CoV-2 variants were investigated via an SARS-CoV-2 Surrogate Virus Neutralization Test (sVNT) based on the RBD-ACE2 competitive binding assay. In all the groups, the better antibody responses were against wild-type strain, Alpha and Delta vari... | PMC10585368 | ||
Spike-specific IgG B-cell responses | To further investigate the ability of the boosters to induce antigen-specific B-cell responses, spike-specific IgG spots were detected at baseline and at 28 days and 6 months after booster vaccination in R848-activated peripheral blood mononuclear cells (PBMCs) (Wild-type SARS-CoV-2 spike-specific IgG B-cell responses.... | PMC10585368 | ||
Spike-specific IFNγ responses | Spike-specific IFNγ responses were detected at days 0, 14, 28 and month 6 after booster vaccination to determine the T-cell responses (SARS-CoV-2 spike-specific IFNγ ELISpot responses. | PMC10585368 | ||
Discussion | T-cell immunity, infection, dimer vaccine | INFECTION | In China, where more than 95% of individuals vaccinated against COVID-19 received inactivated vaccines, we evaluated the immunogenicity of homologous and heterologous boosters in adults who received prime vaccination with two doses of the inactivated COVID-19 vaccine approximately 6 months prior. Both homologous and he... | PMC10585368 |
Data availability statement | The original contributions presented in the study are included in the article/ | PMC10585368 | ||
Ethics statement | The studies involving humans were approved by the Ethics Committee of 305 Hospital of PLA. The studies were conducted in accordance with the local legislation and institutional requirements. The participants provided their written informed consent to participate in this study. | PMC10585368 | ||
Author contributions | MH, ZHZ | RECRUITMENT | YS is the principal investigator of this trial. WC, LH, YWL, and KL designed the trials and the study protocol. ZZ and SW drafted the manuscript. WC and LH contributed to critical review and revising of the report. ZZ, SW, YWL, and KL contributed to data interpretation and revising the manuscript. SW led laboratory ana... | PMC10585368 |
Conflict of interest | TZ is the employee of CanSino Biologics and has stock options in CanSino Biologics.The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. | PMC10585368 | ||
Publisher’s note | All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or ... | PMC10585368 | ||
Supplementary material | REGRESSION | The Supplementary Material for this article can be found online at: RBD-specific IgG reverse cumulative distribution curves. Reverse cumulative distribution curves denote the percentage of participants in each group that reach a different level of antibody concentration at days 0, 7, 14, 28 and months 3 and 6 after the... | PMC10585368 | |
References | PMC10585368 | |||
Background | SECONDARY, HOLIDAY | Emerging evidence suggests that children’s fatness increases and fitness declines at a greater rate during the summer holiday period, compared with the school year. The aim of this study was to compare rates of change in fitness and fatness over the in-term and summer holiday periods among Australian schoolchildren. A ... | PMC10601165 | |
Methods | HOLIDAY | Children (n = 381) initially in Grade 4 (age 9) were recruited for this 2-year longitudinal study. Fatness (% body fat, BMI z-score, waist-to-height ratio) and fitness (20-m shuttle run and standing broad jump) were measured at the start and end of two consecutive years. Rates of change were calculated for the two in-s... | PMC10601165 | |
Results | overweight | HOLIDAYS | During the holidays, percentage body fat increased at a greater rate (annualised rate of change [RoC]: +3.9 vs. Grade 4 and + 4.7 vs. Grade 5), and aerobic fitness declined at a greater rate (RoC − 4.7 vs. Grade 4 and − 4.4 vs. Grade 5), than during the in-school periods. There were no differences in rates of change fo... | PMC10601165 |
Conclusion | HOLIDAY | This study highlights that during the summer holiday period, children experience greater increases in fatness and declines in fitness, with children who live with low-SES families and are overweight being more affected. The findings suggest the need for targeted interventions during this period to address these negativ... | PMC10601165 | |
Trial registration | Australia New Zealand Clinical Trials Registry, identifier ACTRN12618002008202. Retrospectively registered on 14 December 2018. | PMC10601165 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12889-023-17009-4. | PMC10601165 | ||
Keywords | PMC10601165 | |||
Background | HOLIDAYS, SECONDARY, HOLIDAY | Physical fitness and body composition play a crucial role in the overall health and wellbeing of children [Recent research suggests that increases in fatness and declines in aerobic fitness in children occur at a greater rate during the school summer holiday period compared to the school year [The “Structured Days Hypo... | PMC10601165 | |
Materials and methods | PMC10601165 | |||
Participants | The participants in this study were drawn from the | PMC10601165 | ||
Measures | The dependent variables were measures of fatness (percentage body fat, Body Mass Index (BMI) z-score and waist-to-height ratio) and fitness (maximal aerobic power, standing broad jump). Each child’s height was measured using a Seca 213 stadiometer (Seca, Hamburg, Germany), and weight and percentage body fat (The Pubert... | PMC10601165 | ||
Bias | Numerous efforts were made to minimise study biases. In particular, a randomised stratified sampling methodology was used. Outcomes were gathered using high-quality tools and protocols with established reliability and validity. Research personnel were thoroughly trained, and participant retention was maximised through ... | PMC10601165 | ||
Sample size justification | Full details of the power calculation are provided in the study protocol [ | PMC10601165 | ||
Analysis | HOLIDAY | Figure
Schematic of data treatment to extrapolate the rates of change in fatness and fitness across Grade 4, Grade 5 and the holiday period. Outcomes (here, estimated VOMulti-level models were carried out in R [ | PMC10601165 | |
Results | overweight | HOLIDAYS, HOLIDAY | Participant characteristics are shown in Table
Participant characteristicsData are shown for the outcome with the largest sample size (n = 156 for SBJ)BMI = Body Mass Index; SES = socio-economic statusTable
Observed rates of change (means, SDs) for fatness and fitness outcomes across the study timepoints.%BF = percen... | PMC10601165 |
Sex | Sex did not moderate differences in rates of change for any outcome. | PMC10601165 | ||
Socio-economic status | HOLIDAYS | SES moderated differences in the rate of change in %BF and zBMI. Overall, children from lower SES families showed greater increases in fatness over the holidays compared to children from higher SES families. Every 1 SD increase in SES was associated with a 7.5%BF/year greater difference in the rate of change during the... | PMC10601165 | |
Pubertal status | HOLIDAYS, HOLIDAY | Pubertal status moderated differences in rates of change in all fatness measures. Children who were early pubertal in Grade 4 showed relatively lower increases in all fatness measures over the holidays compared to children who were mid-pubertal (p = 0.023–0.046). In Grade 5, these differences were similar but did not r... | PMC10601165 | |
Weight status | overweight | OBESE, HOLIDAY | Weight status moderated differences in rates of change in %BF. Compared to children of normal-weight, children who were overweight (but not obese) increased %BF relatively faster in the holiday periods than in both in-school periods (p = 0.020–0.027). The corresponding rate of decline in aerobic fitness for children wh... | PMC10601165 |
Discussion | PMC10601165 | |||
Main findings | weight gain, overweight, adiposity | HOLIDAYS, HOLIDAY, ADIPOSITY | The focus of this study was to compare rates of change in children’s fitness and fatness between in-school and summer holiday periods, and to explore whether differences in rates of change in these outcomes were moderated by sex, SES, pubertal status, or weight status. During the holiday period, there was a significant... | PMC10601165 |
Strengths and limitations | HOLIDAYS, HOLIDAY | Key strengths of the current study are its longitudinal design spanning two school years. Furthermore, it used the highest quality measures of fatness and fitness possible for collection in a school setting. Relatively few studies of children’s summer holiday fatness and fitness have been conducted outside the US, and ... | PMC10601165 | |
Implications | weight gain | HOLIDAYS, HOLIDAY | If the holiday environment leads to increases in fatness and decreases in aerobic fitness, there are potential policy implications. Interventions targeted at the holiday period (such as summer camps and programs which offer a mix of physical and learning activities), at the home environment, or at effectively extending... | PMC10601165 |
Conclusion | overweight | HOLIDAY | In summary, this study provides important insights into the differential rates of change in children’s fitness and fatness during in-school and summer holiday periods. Our findings suggest that during the holiday period, there is a significant increase in the rate of change of percentage body fat and a significant decl... | PMC10601165 |
Acknowledgements | Not applicable. | PMC10601165 | ||
Authors’ contributions | CM | HOLIDAYS | TO and CM developed the concept for this study. TO, CM, DD, FF, GT & RG obtained funding for the original Life on Holidays study. TO, CM, EE & AM drafted the manuscript. DD performed the analysis. All authors have read and approved the final version of the manuscript and agree with the order of presentation of the auth... | PMC10601165 |
Funding | CM | HOLIDAYS | The life on Holidays study was funded by the National Health and Medical Research Council [grant number APP1143379] (2018–2022). The funding body played no role in the design, collection, analysis and interpretation of data or in writing the manuscript. AW is supported by NHMRC Project Grant APP143379 (2018–2022). CM i... | PMC10601165 |
Data Availability | Data analysed during this study will be made available upon reasonable request to the corresponding author Carol Maher by emailing her at carol.maher@unisa.edu.au. | PMC10601165 | ||
Declarations | PMC10601165 | |||
Competing interests | The authors declare no competing interests. | PMC10601165 | ||
Ethics approval and consent to participate | Ethical approval was obtained from the University of South Australia Human Research Ethics Committee, Adelaide, Australia (200980), the South Australian Department of Education and Child Development (2008-0055) and the Adelaide Catholic Education Centre (201820). All methods were carried out in accordance with relevant... | PMC10601165 | ||
Consent for publication | Not applicable. | PMC10601165 | ||
References | PMC10601165 | |||
Keywords | ChiCTR2000039383, pain, fractures, diaphragmatic paralysis, hemidiaphragmatic paresis | The sensory innervation of the clavicle is complex, and the best regional block technology for clavicular surgery has yet to be determined. The purpose of this study was to compare the application of ultrasound-guided superficial cervical plexus block combined with clavipectoral fascial plane block verses interscalene ... | PMC10371927 | |
Introduction | upper limb muscle strength, fracture, clavicular fracture, Clavicular fracture, clavicle fracture, nausea, vomiting | ADVERSE REACTIONS, LARYNGEAL SPASM, COMPLICATIONS | Clavicular fracture is the most common injury in the shoulder, particularly in young men. It mainly occurs due to sports or traffic accidents, especially in the middle of the clavicle. Better functional results can be obtained by surgical treatment. General anaesthesia can be used during surgery, but there is a risk of... | PMC10371927 |
Materials and methods | PMC10371927 | |||
Study design and participants | cardio-cerebrovascular diseases, abnormal blood coagulation, allergy, fractures, hypertension | RESPIRATORY INSUFFICIENCY, ALLERGY, CORONARY HEART DISEASE, HEART FAILURE, HYPERTENSION, OBSTRUCTIVE EMPHYSEMA, PUNCTURE SITE INFECTION | This is a single-centre double-blind, randomized controlled trial of 50 patients with American Society of Anaesthesiologists (ASA) I-II at our hospital (Teaching Hospital, Residency training Hospital). This study was performed in line with the principles of the Declaration of Helsinki. Hospital ethics committee approva... | PMC10371927 |
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