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 | All data files are available from the DataverseNL database (persistentId=doi: | PMC10754450 | ||
Introduction | submucous fibroids | COMPLICATION | Hysteroscopic myomectomy is the treatment of first choice for submucous fibroids. Traditionally this procedure was performed in an operating room with general anesthesia (GA) [Procedural sedation and analgesia (PSA) is a technique of administering sedative agents with or without analgesics to create a decreased level o... | PMC10754450 |
Methods | PMC10754450 | |||
Ethics statement | The study was conducted according to the principles of the Declaration of Helsinki (World Medical Association Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects, Version Fortaleza, Brazil, October 2013,) and ethical approval was granted by the ethics committee of the Máxima Medical... | PMC10754450 | ||
Trial design | The PROSECCO study was a multicenter noninferiority randomized controlled trial. The study was performed in 14 university and teaching hospitals in the Netherlands, collaborating in the Dutch Consortium for Healthcare Evaluation and Research in Obstetrics and Gynecology, between 2016 and 2021. The study was registered ... | PMC10754450 | ||
Participants | fibroids | FIBROIDS | Women were found eligible for inclusion if they had a minimum age of 18 years and if symptomatic International Federation of Gynecology and Obstetrics (FIGO) type 0 or 1 fibroids [ | PMC10754450 |
Interventions | Patients were randomized to either PSA or GA. PSA was nonanesthesiologist-administered propofol (NAAP) sedation, administered and monitored by a qualified sedation practitioner according to the guidelines from the Health Care Inspectorate (IGZ) and Dutch Institute for Healthcare Improvement (CBO) [GA could be inhalatio... | PMC10754450 | ||
Outcomes | fibroid, NRS, pain | ADVERSE EVENTS, FIBROID, APPENDIX | The primary outcome was the percentage of complete resections, evaluated by transvaginal ultrasonography (TVU) (contrast sonography when TVU was inconclusive) 6 weeks postoperatively. Complete resection was defined as the absence of an intracavitary remnant of the fibroid (s) resected during hysteroscopic myomectomy. T... | PMC10754450 |
Sample size | Prior to the study, the incidence of incomplete resections was estimated to be 2.5% in both treatment groups based on expert opinion and previous literature [ | PMC10754450 | ||
Randomization and blinding | Randomization was performed by using an internet-based randomization program in a 1:1 ratio with random permuted blocks of sizes 2, 4, or 6 and was stratified by the surgical technique used (morcellation or resection). Treating physicians and patients were not blinded for the allocated treatment. However, the sonograph... | PMC10754450 | ||
Statistical methods | SECONDARY | Data were analyzed according to the intention-to-treat (ITT) principle. Given the noninferiority design of the study, we also performed a per-protocol (PP) for the primary outcome. Imputation of missing data was not used.The primary outcome was evaluated by estimating the risk difference between both treatment arms, wi... | PMC10754450 | |
Patient and public involvement | Patients were actively involved in the design of the study, through the Dutch Gynecologic Patient Organization (PGN: Patiëntenvereniging Gynaecologie Nederland), in which gynecologic patients are organized. This organization endorsed the importance of the research question and was involved in the design of the protocol... | PMC10754450 | ||
Results | PMC10754450 | |||
Participants | Between February 2016 and December 2019, 256 women were found eligible for participation. After written informed consent was obtained, 209 women were randomly allocated to hysteroscopic myomectomy under PSA ( | PMC10754450 | ||
Flow diagram of PROSECCO trial. | fibroids | FIBROIDS | GA, general anesthesia; ITT, intention to treat; PP, per protocol; PSA, procedural sedation and analgesia. The PP population was defined as any patient who underwent myomectomy with GA or PSA as allocated using randomization. Patients who did not have a myomectomy or who did not receive the type of anesthesia allocated... | PMC10754450 |
Patient and fibroid baseline characteristics. | Percentages are column percentages based on the number of observations available. PSA: Procedural sedation and analgesia, GA: General anesthesia, BMI: Body Mass Index, IQR: Interquartile Range, sd: standard deviation,. *multiple reasons can apply. | PMC10754450 | ||
Loss of follow-up and missing data | SECONDARY | For 8 women (7.5%) in the PSA group, the primary outcome (TVU at 6 weeks postsurgery) was missing. In the GA group, the TVU result was unavailable for 14 women (13.6%). Among these women, 7/8 in the PSA group and 8/14 in the GA group did complete the digital questionnaires and could still be included in analyses for se... | PMC10754450 | |
Primary outcome | Hysteroscopic resection was complete (as based on TVU) in 86/98 (87.8%) women under PSA and in 79/89 (88.8%) under GA (risk difference −1.01%; 95% CI −10.36 to 8.34). Although the difference in completeness between both groups was very small, significant noninferiority could not be demonstrated ( | PMC10754450 | ||
Secondary outcomes | PERIOPERATIVE COMPLICATION | There was no significant difference in surgeon’s judgment on completeness of resection in the PSA group compared to the GA group (79/106 (74.5%) versus 82/99 (82.8%), RR 0.90; 95% CI 0.78 to 1.04; A significant difference in median NRS score was observed between the PSA group and GA group in favor of the GA group immed... | PMC10754450 | |
Anesthetic complications. | CI, confidence interval; GA, general anesthesia; PSA, procedural sedation and analgesia.Percentages are column percentages based on the number of observations available (i.e., excluding missing observations). Relative risk with 95% CI and chi-squared test.*Multiple answers can apply.There was no significant difference ... | PMC10754450 | ||
Surgical reinterventions. | SAEs | PSA: Procedural sedation and analgesia, GA: general anesthesia, RF: radiofrequency. Percentages are column percentages based on the number of observations available. Relative risk with 95% confidence interval and Chi-squared test.PBAC score, EQ-5D-5L score, and UFS-QoL score significantly improved over time compared to... | PMC10754450 | |
Serious adverse events. | ADVERSE EVENT | GA, general anesthesia; PSA, procedural sedation and analgesia; SAE, serious adverse event.Values are presented as number of women with percentage. | PMC10754450 | |
Discussion | PMC10754450 | |||
Main findings | fibroid | MINOR, SECONDARY, FIBROID, COMPLICATIONS | This multicenter RCT comparing PSA with GA for hysteroscopic myomectomy found similar percentages for completeness of fibroid resection in both groups (87.8% and 88.8%). However, significant noninferiority could not be demonstrated. Among secondary endpoint findings, hysteroscopic myomectomy appeared to lead to a consi... | PMC10754450 |
Strengths and weaknesses of the study | bleeding, fibroid, blood loss, TVU, fibroids | UTERINE FIBROID, BLEEDING, RECURRENCE, FIBROID, BLOOD LOSS, FIBROIDS | An important strength of this study is that it is the first RCT on PSA versus GA for hysteroscopic myomectomy. Secondly, it was a multicenter study, in which 14 hospitals in the Netherlands participated, resulting in generalizable results. Thirdly, sonographers evaluating the primary outcome were blinded for the treatm... | PMC10754450 |
Unanswered questions and future research | uterine fibroid | UTERINE FIBROID | Since hysteroscopic myomectomy under PSA reduces hospital admission duration in comparison to GA, it can be assumed to result in a reduction of overall costs. Alongside this study, we conducted a cost effectiveness study, of which results will be published at a later stage.Although quality of life did improve (both gen... | PMC10754450 |
Conclusions | fibroids | FIBROIDS | Noninferiority of PSA to GA for completeness of resection could not be demonstrated. However, there were no differences in clinical outcomes and quality of life. In this study, hysteroscopic myomectomy for type 0 and 1 fibroids with PSA compared to GA was safe and led to shorter hospitalization. Gynecologists and anest... | PMC10754450 |
Supporting information | PMC10754450 | |||
CONSORT 2010 checklist of information to include when reporting a randomised trial. | (DOC)Click here for additional data file. | PMC10754450 | ||
Prosecco trial. | (PDF)Click here for additional data file. | PMC10754450 | ||
Supporting information PROSECCO trial. | hysteroscopische, NRS | POSTOPERATIVE COMPLICATION, RECURRENCE, APPENDIX | Appendix 1. Questionnaires. Vragenlijst bijwerkingen 24 uur na hysteroscopische myoomresectie (Dutch version). Questionnaire on side effects 24 hours after hysteroscopic myomectomy (English version). Vragenlijst evaluatie recidief na hysteroscopische myoomresectie (Dutch version). Questionnaire for evaluation of recurr... | PMC10754450 |
Abbreviations | ScalePictorial Blood Loss | FIBROIDS | American Society of Anesthesiologistsconfidence intervalData and Safety Monitoring BoardInternational Federation of Gynecology and Obstetricsgeneral anesthesiaintention to treatnonanesthesiologist-administered propofolNumeric Rating ScalePictorial Blood Loss Assessment Chartper-protocolprocedural sedation and analgesia... | PMC10754450 |
References | PMC10754450 | |||
Objectives | RPDs, MIs, dentitions, partial dentures | Stability values of mini-implants (MIs) are ambiguous. Survival data for MIs as supplementary abutments in reduced dentitions are not available. The aim of this explorative research was to estimate the 3-year stability and survival of strategic MIs after immediate and delayed loading by existing removable partial dentu... | PMC10102135 | |
Material and methods | MIs, tooth | In a university and three dental practices, patients with unfavorable tooth distributions received supplementary MIs with diameters of 1.8, 2.1, and 2.4 mm. The participants were randomly allocated to group A (if the insertion torque ≥ 35 Ncm: immediate loading by housings; otherwise, immediate loading by RPD soft reli... | PMC10102135 | |
Results | RPDs | A total of 112 maxillary and 120 mandibular MIs were placed under 79 RPDs (31 maxillae). The 1st and 3rd quartile of the PTVs ranged between 1.7 and 7.8, and the RFA values ranged between 30 and 46 with nonrelevant group differences. The 3-year survival rates were 92% in group A versus 95% in group B and 99% in the man... | PMC10102135 | |
Conclusions | MIs | Within the limitations of explorative analyses, there were no relevant differences between immediate and delayed loading regarding survival or stability of strategic MIs. | PMC10102135 | |
Clinical relevance | MIs, cluster failure | The stability values for MIs are lower than for conventional implants. The MI failure rate in the maxilla is higher than in the mandible with cluster failure participants. | PMC10102135 | |
Clinical trial registration | German Clinical Trials Register (Deutsches Register Klinischer Studien, DRKS-ID: DRKS00007589, | PMC10102135 | ||
Keywords | Open Access funding enabled and organized by Projekt DEAL. | PMC10102135 | ||
Introduction | partial dentures, edentulous mandibular arches, MIs, RPD, RPDs, tooth | SECONDARY, ATROPHIED, LEAKAGE | In jaws with few remaining teeth or unfavorable distribution between quadrants, strategic dental implants can serve as supplementary abutments for a symmetric support and more stability of removable partial dentures (RPD) [Unfortunately, conventional two-piece implants are cost-intensive and sometimes require bone augm... | PMC10102135 |
Material and methods | PMC10102135 | |||
Study procedures | tooth | This multicenter RCT in a university hospital and three dental practices was approved by the Ethics Committee of the Greifswald University (BB 058/13A). All participants gave their written informed consent prior to inclusion in the study. Participants were patients with an RPD in one or both jaws with comparably unfavo... | PMC10102135 | |
Data assessment | An independent expert dentist examined the patients before the surgery (Implants that soundly maintained their function were considered to have survived. Removals or spontaneous losses of implants were defined as failure [The Periotest instrument (Medizintechnik Gulden, Bensheim, Germany) was used to measure MI stabili... | PMC10102135 | ||
Statistical analyses | tooth | REGRESSION | Continuous variables are represented as median (1st–3rd quartile) because of asymmetric data distributions. To compare stability values between the treatment groups, mixed models were used on three levels, namely person, tooth site, and time as continuous variable [The Kaplan–Meier analyses were performed as descriptiv... | PMC10102135 |
Results | PMC10102135 | |||
Participant’s characteristics | long-term illness, RPDs, tooth | RECRUITMENT | Because one of the participating surgeons had a long-term illness, 12 participants received no MI in the study period (Fig. Flowchart of the participantsThe recruitment period ranged between January 2014 and July 2015. The study ended in July 2018. The new or optimized RPDs of the 79 study jaws (31 maxillae) were eithe... | PMC10102135 |
Mini-implants survival rate | REGRESSION | A total of 8 failures were registered in three participants of group A versus 5 failures in two participants of group B, which resulted in cumulative 3-year survival rates of 92% versus 95% (Fig. Survival rate probabilities of mini-implants by groupSurvival rate probabilities of mini-implants by jawAccording to Cox reg... | PMC10102135 | |
Discussion | edentulous maxillae, MIs, RPDs, mandibular MIs, maxillary MIs, implant loss | The primary outcome of this randomized trial was bone level changes of either immediately loaded MI in group A or delayed loaded MI in group B as supplementary abutments under existing RPDs. The assessment of bone heights at MIs on the panoramic radiographs are more sophisticated than expected, and the analyses are sti... | PMC10102135 | |
Acknowledgements | We thank Dr. Bernd Schwahn, Greifswald, and Dr. Janine Hilgert, Drensteinfurt, who treated study participants and provided their dental offices for the data collection. | PMC10102135 | ||
Author contribution | T.M. | T.M., F.H., C.S., and A.A. had substantial contributions to the conception and design of the work and to the interpretation of data. T.M., F.H., and A.A. acquired the data. J.M. and C.S. controlled the data and checked their plausibility. C.S. provided the statistical analyses. T.M. and J.M. drafted the manuscript. F.H... | PMC10102135 | |
Funding | Open Access funding enabled and organized by Projekt DEAL. This study was financially supported by the 3 M Deutschland GmbH, Germany. The company did not participate in the study design; data assessment and analysis; the decision to publish, or manuscript preparation. | PMC10102135 | ||
Data availability | Data are available on request from the corresponding author. | PMC10102135 | ||
Declarations | PMC10102135 | |||
Ethics approval | All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The study design was approved by the Ethics Committee of... | PMC10102135 | ||
Consent to participate and to publish | Informed consent was obtained from all individual participants included in the study. The authors affirm that human research participants provided informed consent for publication of the images in Figs. | PMC10102135 | ||
Competing interests | T.M. and F.H. use the implant system and receive fees for lectures and further training on mini-implants, including the implant manufacturer. There are no conflicts of interest for the co-authors. | PMC10102135 | ||
References | PMC10102135 | |||
Key Points | PMC10157429 | |||
Question | Do the protein-based SARS-CoV-2 vaccines (FINLAY-FR-2 and FINLAY-FR-1A) provide safe and effective protection against SARS-CoV-2? | PMC10157429 | ||
Findings | ASYMPTOMATIC COVID-19, DISEASE, ADVERSE EVENTS | In this randomized clinical trial including 23 959 individuals, vaccine efficacy for prevention of polymerase chain reaction (PCR)–positive symptomatic COVID-19 was 49.7%; severe disease, 76.8%; and hospitalization, 77.7% after the 2-dose regimen of FINLAY-FR-2, which improved to 64.9% for prevention of PCR-positive sy... | PMC10157429 | |
Meaning | The findings of this trial suggest that FINLAY-FR-2, in combination with a third dose of FINLAY-FR-1A, is a safe vaccine inducing a potent immune response against COVID-19. | PMC10157429 | ||
Importance | The protein-based SARS-CoV-2 vaccines FINLAY-FR-2 (Soberana 02) and FINLAY-FR-1A (Soberana Plus) showed good safety and immunogenicity in phase 1 and 2 trials, but the clinical efficacy of the vaccine remains unknown. | PMC10157429 | ||
Objective | To evaluate the efficacy and safety of a 2-dose regimen of FINLAY-FR-2 (cohort 1) and a 3-dose regimen of FINLAY-FR-2 with FINLAY-FR-1A (cohort 2) in Iranian adults. | PMC10157429 | ||
Design, Setting, and Participants | COAGULATION DISORDERS | A multicenter, randomized, double-blind, placebo-controlled, phase 3 trial was conducted at 6 cities in cohort 1 and 2 cities in cohort 2. Participants included individuals aged 18 to 80 years without uncontrolled comorbidities, coagulation disorders, pregnancy or breastfeeding, recent immunoglobulin or immunosuppressi... | PMC10157429 | |
Interventions | In cohort 1, 2 doses of FINLAY-FR-2 (n = 13 857) or placebo (n = 3462) were administered 28 days apart. In cohort 2, 2 doses of FINLAY-FR-2 plus 1 dose of FINLAY-FR-1A (n = 4340) or 3 placebo doses (n = 1081) were administered 28 days apart. Vaccinations were administered via intramuscular injection. | PMC10157429 | ||
Main Outcomes and Measures | infection | ASYMPTOMATIC COVID-19, INFECTION, ADVERSE EVENTS | The primary outcome was polymerase chain reaction–confirmed symptomatic COVID-19 infection at least 14 days after vaccination completion. Other outcomes were adverse events and severe COVID-19. Intention-to-treat analysis was performed. | PMC10157429 |
Results | deaths | ADVERSE EVENTS | In cohort 1 a total 17 319 individuals received 2 doses and in cohort 2 5521 received 3 doses of the vaccine or placebo. Cohort 1 comprised 60.1% men in the vaccine group and 59.1% men in the placebo group; cohort 2 included 59.8% men in the vaccine group and 59.9% in the placebo group. The mean (SD) age was 39.3 (11.9... | PMC10157429 |
Conclusions and Relevance | infections | ASYMPTOMATIC COVID-19, INFECTIONS | In this multicenter, randomized, double-blind, placebo-controlled, phase 3 trial of the efficacy and safety of FINLAY-FR-2 and FINLAY-FR-1A, 2 doses of FINLAY-FR-2 plus the third dose of FINLAY-FR-1A showed acceptable vaccine efficacy against symptomatic COVID-19 as well as COVID-19–related severe infections. Vaccinati... | PMC10157429 |
Trial Registration | isrctn.org Identifier: This randomized clinical trial evaluates the efficacy and safety of the FINLAY-FR-2 and FINLAY-FR-1A COVID-19 vaccines in the Iranian population. | PMC10157429 | ||
Introduction | tetanus | CURBING, VIRUS, TETANUS | Vaccines have been considered one of the most important interventions for curbing the COVID-19 pandemic. COVID-19 vaccine studies have been conducted based on different approaches including the first-generation platforms (eg, attenuated and inactivated virus vaccines), the second-generation vaccines, such as replicatin... | PMC10157429 |
Methods | PMC10157429 | |||
Study Design and Participants | chronic kidney disease, chronic liver disease | MAY, TYPE 2 DIABETES, CHRONIC LIVER DISEASE, HYPERTENSION | A multicenter, randomized, double-blind, parallel-group, placebo-controlled phase 3 clinical trial was conducted to evaluate the efficacy, safety, and immunogenicity of a 2-dose regimen of conjugated protein-based FINLAY-FR-2, 25 μg, in one cohort (cohort 1) and a 2-dose regimen of FINLAY-FR-2 with a third dose of FINL... | PMC10157429 |
Randomization | Randomization was conducted using a stratified balanced block randomization approach (block size: 25, stratum variable: city) on day 0, at a 4:1 ratio. Participants, study staff, and investigators were blinded for group allocation. Allocations were concealed through the central assignment. The vaccine and placebo vials... | PMC10157429 | ||
Procedures | FINLAY-FR-2 was administered via intramuscular injection, 28 days apart. FINLAY-FR-1A was used as a third dose in cohort 2 on day 56. Vaccine composition is presented in the eMethods in QuantiVac ELISA (enzyme-linked immunosorbent assay IgG) kit (Euroimmun, Germany) was used to determine the titration of anti-S1 IgG (i... | PMC10157429 | ||
Outcomes | death | ASYMPTOMATIC COVID-19, EVENTS, ADVERSE EVENTS | Consistent with other vaccine trials, the primary outcome was symptomatic COVID-19, confirmed by RT-PCR 14 days after the second and third doses. Secondary outcomes were severe COVID-19, COVID-19–related death, adverse events (AEs), and humoral and cellular immune responses (eMethods in Participants recorded solicited ... | PMC10157429 |
Statistical Analysis | ADVERSE EVENT | The sample size was calculated to be approximately 18 000 participants in cohort 1 (vaccine: 14 400, placebo: 3600) and 6000 in cohort 2 (vaccine: 4800, placebo: 1200) (eMethods in Seroconversion was defined as a 4-fold increase in anti–SARS-CoV-2 S1 IgG titer compared with the baseline. Adverse events were compared be... | PMC10157429 | |
Results | PMC10157429 | |||
Participants | MAY | Between April 26 and May 23, 2021, of 24 126 volunteers screened, 18 000 were randomized to placebo or vaccine in cohort 1 and 6000 were randomized to placebo or vaccine in cohort 2. A total of 23 959 participants (cohort 1 [n = 17 972] and cohort 2 [n = 5987]) were randomly assigned to receive the vaccine (n = 19 165)... | PMC10157429 | |
Trial Profile | Reasons for unmet inclusion criteria in screened participants are reported in eTable 10 in Of participants who underwent a serologic test on day 0 (cohort 1, 5905; cohort 2, 1975), 35.7% of those in the cohort 1 vaccine group and 33.7% of those in the cohort 2 vaccine group, as well as 36.7% of those in the cohort 1 pl... | PMC10157429 | ||
Baseline Characteristics of the Participants Who Received at Least 1 Dose of the Assigned Treatment | obesity, chronic kidney disease, malignancy, cancer, asthma, type 2 diabetes | OBESITY, UNCONTROLLED HYPERTENSION, ISCHEMIC HEART DISEASE, CANCER, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, ASTHMA, TYPE 2 DIABETES, DISEASES, CHRONIC LIVER DISEASE | Abbreviations: BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); IgG, immunoglobulin G.Underlying diseases: obesity (BMI >30), controlled hypertension, chronic kidney disease, chronic liver disease, type 2 diabetes, chronic obstructive pulmonary disease), controlled asthma, h... | PMC10157429 |
Immunologic Response | In the vaccine group, the seroconversion rates of anti–SARS-CoV-2 S1 IgG increased 4 weeks after the second (81.1% [95% CI, 79.7%-82.2%]) and third (92.9% [95% CI, 91.4%-94.2%]) doses (A specific IFN-γ response to SARS-CoV-2 S1 was analyzed in 363 participants 4 weeks after the second dose (295 from the vaccine group a... | PMC10157429 | ||
Efficacy | The median follow-up time for cohort 1 was 100 days (IQR, 96-106 days), and for cohort 2, 142 days (IQR, 137-148 days). In cohort 1, 461 (3.2%) symptomatic cases in the vaccine group and 221 (6.1%) in the placebo group were observed, which yielded a vaccine efficacy (VE) of 49.7% (95% CI, 40.8%-57.3%). In cohort 2, 75 ... | PMC10157429 | ||
Cumulative Incidence of COVID-19 Incident Cases (1 – Kaplan-Meier Estimate) in the Primary Analysis Following the First Dose of Vaccine or Placebo in the 2-Dose and 3-Dose Regimens | PMC10157429 | |||
Vaccine Efficacy Against SARS-CoV-2, 14 Days After the Second and Third Doses in Cohort 1 and Cohort 2 Among the Vaccine and Placebo Groups | death | ASYMPTOMATIC COVID-19, SECONDARY | Confirmed symptomatic COVID-19 indicates the primary outcome, and severe cases as the secondary outcome; only 1 COVID-19–related death was observed in the placebo group during the follow-up period in cohort 1.Vaccine efficacy was defined as a 1 – The spike gene sequencing analysis of 419 participants with RT-PCR–positi... | PMC10157429 |
Safety | Solicited AEs at the injection site were reported more frequently in the vaccine group than the placebo group after the first dose (7269 [38.2%] vs 737 [15.5%]), second dose (6470 [35.7%] vs 649 [14.4%]), and third dose (1042 [25.0%] vs 98 [9.3%]) ( | PMC10157429 | ||
Local and Systemic Adverse Events After Injection of the First, Second, and Third Doses Among Participants Who Received Vaccine or Placebo | Fatigue | ADVERSE EVENTS | AEs indicates adverse events; RR, risk ratio.Systemic solicited AEs were more common in the vaccine group than in the placebo group after the first dose (5585 [29.3%] vs 1211 [25.5%]), second dose (4427 [24.4%]) vs 977 [21.7%]), and third dose (739 [17.7%] vs 148 [14.1%]). Fatigue was the most common systemic AE in bot... | PMC10157429 |
Discussion | infection, infections | INFECTION, SARS-COV-2 INFECTION, INFECTIONS | Our analysis showed that the VE of 2 doses of FINLAY-FR-2 (cohort 1) in preventing symptomatic infections was 49.7% of the participants, severe cases in 76.8%, and COVID-19–related hospitalizations in 77.7%. Vaccine efficacy was higher in recipients of the third dose (cohort 2), at 64.9%, for preventing symptomatic inf... | PMC10157429 |
Limitations | DISEASES | We acknowledge the limitations of this study. First, up to 30% of volunteers with controlled underlying diseases were selected. This may have impacted the overall VE in this study. Second, we could not run serologic tests for all our participants at baseline due to our limited resources in Iran. Third, given that the o... | PMC10157429 | |
Conclusions | In this multicenter, randomized, double-blind, placebo-controlled, phase 3 clinical trial, the study findings indicate that the FINLAY-FR-2 vaccine, in addition to the third dose of FINLAY-FR-1A, has acceptable VE against symptomatic cases and high efficacy against severe cases of COVID-19 and COVID-19–related hospital... | PMC10157429 | ||
Background | infection, SARS-CoV-2 infection | INFECTION, SARS-COV-2 INFECTION, VIRAL INFECTION | To protect school-aged children from the potential consequences of a new viral infection, public health authorities recommended to implement infection prevention and control (IPC) measures in school settings. Few studies evaluated the implementation of these measures and their effect on SARS-CoV-2 infection rates among... | PMC10185463 |
Methods | SECONDARY | We conducted a prospective cohort study in a representative sample of primary and secondary schools in Belgium between December 2020 and June 2021. The implementation of IPC measures in schools was assessed using a questionnaire. Schools were classified according to their compliance with the implementation of IPC measu... | PMC10185463 | |
Results | A variety of IPC measures (ventilation, hygiene and physical distancing) was implemented by more than 60% of schools, with most attention placed on hygiene measures. In January 2021, poor implementation of IPC measures was associated with an increase in anti-SARS-CoV-2 antibody prevalence among pupils from 8.6% (95%CI:... | PMC10185463 | ||
Conclusions | Belgian schools were relatively compliant with recommended IPC measures at the school level.Higher SARS-CoV-2 seroprevalence among pupils and staff was found in schools with poor implementation of IPC measures, compared to schools with thorough implementation. | PMC10185463 | ||
Trial registration | This trial is registered under the NCT04613817 ClinicalTrials.gov Identifier on November 3, 2020. | PMC10185463 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12889-023-15806-5. | PMC10185463 | ||
Keywords | PMC10185463 | |||
Background | infection | INFECTION, SECONDARY, MAY | To protect the global population, including school-aged children, against the spread of SARS-CoV-2, national and regional authorities implemented infection prevention and control (IPC) measures in various societal settings. Because the role of school-aged children in the transmission dynamics was unclear, IPC measures ... | PMC10185463 |
Methods | This analysis is based on data collected through a country-wide representative longitudinal prevalence study on SARS-CoV-2 antibodies among Belgian pupils and school staff during the school year 2020 – 2021 [ | PMC10185463 | ||
Study design | Data on the implementation of IPC measures were collected from schools at the start of the study in December 2020/January 2021, and again in March and May/June 2021. At these three data collection periods, saliva samples were taken from (the same) pupils and staff to determine the prevalence of anti-SARS-CoV-2 antibodi... | PMC10185463 |
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