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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Endogenous microbiome pathway activity patterns influence the colonisation efficiency of PDB | To investigate whether variations in the FMM data were associated with the highly variable and subject-specific relative abundance of PDB during the intervention periods, RDA analysis was performed using the FMM determined during the intervention periods and, as explanatory variable, the average relative abundance of P... | PMC9990280 | ||
Discussion | stoma | In this study, we present the longitudinal metataxonomic study of the small intestine microbiota, including diet intervention periods to assess the microbial impact of the consumption of bacteria-rich fermented dairy products. Although metataxonomic analysis was the focus of this study, we also determined whether the i... | PMC9990280 | |
Conclusions | This study shows that the consumption of milk products fermented by | PMC9990280 | ||
Acknowledgements | We would like to thank the Host-Microbe Interactomics group of Wageningen University and the team of Danone Research for the fruitful discussions about the results obtained. We are also grateful to dr.ir. Peter van Baarlen for the excellent inputs, support and discussion. | PMC9990280 | ||
Authors’ contributions | Edoardo Zaccaria Tim Klaassen and Annick M.E. Alleleyn are co-first authors; Michiel Kleerebezem and Freddy J. Troost are co-last authors. Study concept and design: Michiel Kleerebezem, Freddy J. Troost, Tamara Smokvina. Acquisition of data: Tim Klaassen, Annick M.E. Alleleyn, Edoardo Zaccaria, Freddy J. Troost. Analys... | PMC9990280 | ||
Funding | This study was funded by Danone Research via an investigator grant (code: INSIDE:PLF-8712-GD). Study sponsor was not involved in the study design and in the collection, analysis, and interpretation of data nor in the decision to submit this work for publication. | PMC9990280 | ||
Availability of data and materials | The datasets supporting the conclusions of this article are available in the DANS repository, on the following doi: 16S 10.17026/dans-xhw-dhpr, Metatranscriptome 10.17026/dans-xvh-yww8, Permeability test 10.17026/dans-xnp-nkq8, Urine Metabolites: 10.17026/dans-2ad-cx47, Short Chain Fatty Acid profiling 10.17026/dans-z3... | PMC9990280 | ||
Declarations | PMC9990280 | |||
Ethics approval and consent to participate | This study was approved by the Medical Ethics Committee of Maastricht University (MU), Maastricht, the Netherlands, and performed in full accordance with the Declaration of Helsinki (latest amendment by the World Medic Association in Fortaleza, Brazil, in 2013) and Dutch Regulations on Medical Research involving Human ... | PMC9990280 | ||
Consent for publication | Not applicable. | PMC9990280 | ||
Competing interests | This author discloses the following: T. Smokvina is an employee of Danone Research. The remaining authors declare that they have no competing interests. | PMC9990280 | ||
References | PMC9990280 | |||
Methods | We evaluated STI prevalence and incidence and associated risk factors in 162 women aged 18–33 years old, residing in eThekwini and Tshwane, South Africa who were part of the Evidence for Contraceptive Options and HIV Outcomes (ECHO) trial. Women were randomised to use depot medroxyprogesterone acetate (n = 53), copper ... | PMC10637674 | ||
Results | STIS | There were no significant differences in STI incidence and prevalence across contraceptive groups. At baseline, 40% had active STIs (CT, NG, | PMC10637674 | |
Conclusions | STIS | Although the study participants received extensive counselling on the importance of condom use, this study highlights the high prevalence and incidence of STIs in South African women, especially amongst young women, emphasising the need for better STI screening and management strategies. | PMC10637674 | |
Data Availability | The data that support the findings of this study are available in Table S5. | PMC10637674 | ||
Introduction | STIS, SEXUALLY TRANSMITTED INFECTIONS | Sexually transmitted infections (STI) continue to be a global health concern. Most STIs are asymptomatic, often undetected and are therefore left untreated [Multiple behavioral and social factors increase STI risk among young women including inconsistent or lack of condom use, multiple sexual partners [The aim of the s... | PMC10637674 | |
Methods | PMC10637674 | |||
Study participants | The participants in this sub-study were enrolled at the Setshaba Research Centre (SRC) in Tshwane (n = 53) and MatCH Research Unit (MRU) in eThekwini (n = 109) as part of the ECHO trial [ | PMC10637674 | ||
Specimen collection and processing | PROSTATE | For this sub-study, lateral vaginal wall swab samples were collected between June and December 2017 for STI diagnosis and prostate specific antigen (PSA), a biomarker of semen, testing. Specimens were collected at three timepoints—at baseline (immediately before contraceptive method initiation), month one (M1), and mon... | PMC10637674 | |
STI testing | HSV-2 | All participants were tested for CT and NG using a nucleic acid amplification test on the GeneXpert instrument system at screening, the final visit and as clinically indicated in the ECHO trial. Additionally, HSV-2 serologic testing was conducted at screening and final visits as part of the parent trial at Bio Analytic... | PMC10637674 | |
PSA measurement | ® | Swab eluants were transferred into filter centrifuge tubes (Corning® Costar® Spin-X® tubes Sigma-Aldrich, | PMC10637674 | |
Data analysis | Statistical analyses were performed using GraphPad Prism (GraphPad Software, USA) and R Studio (R Studio Software, USA). Women were grouped by age to include approximately equal numbers within each group (18–21; 22–25; 26–33 years). We used the Fisher exact test to compare baseline STI prevalence between groups, includ... | PMC10637674 | ||
Results | PMC10637674 | |||
Cohort characteristics | Baseline demographic, behavioural and clinical characteristics of the study participants are described by age group ( | PMC10637674 | ||
Baseline STI prevalence | HSV-2 | STI prevalence was high overall, with 40% of women having an active STI (CT, NG, TV, MG or HSV-2 shedding), 10% having more than one STI, 19% having CT and 19% having TV ( | PMC10637674 | |
Total proportion of women with active sexually transmitted infections (STIs) at baseline by age group. | STI infections | The younger (18–21, n = 52) and middle (22–25, n = 62) age group had a greater proportion of STI infections than the older age group (26–33, n = 47). The younger age group had a greater proportion of | PMC10637674 | |
Baseline STI prevalence overall and by age group. | Abbreviations: STI, sexually transmitted infection.^tested positive for at least one STI (CT, NG, TV, MG or HSV-2). Proportions were compared using the Fishers Exact test*p<0.05 following Bonferroni correction was considered statistically significant. | PMC10637674 | ||
STI incidence | STIS, EVENT, SEXUALLY TRANSMITTED INFECTION | The incidence of any active STI during the three-month follow-up period was very high [107.9/100 women years (wy); (A-F), Kaplan-Meier curve showing sexually transmitted infection (STI) incidence between age groups over time (days). Red represents the 18–21 year olds, green the 22–25 year olds and blue the 26–33 year o... | PMC10637674 | |
Three-month STI incidence overall and by contraceptive group. | *p<0.05 following Bonferroni correction was considered statistically significant.No statistically significant differences in STI incidence between contraceptive groups was noted, but trends towards higher incidence of any active STI or CT alone were observed in the DMPA-IM arm compared to LNG implant users (p = 0.11 an... | PMC10637674 | ||
Discussion | HIV, adverse pregnancy outcomes and infertility, infection, infections, HIV infection | STIS, INFECTION, INFECTIONS, HIV INFECTION | STIs have a major impact on both sexual and reproductive health and, in addition to their individual pathogenic effects, increase the risk of HIV, adverse pregnancy outcomes and infertility. Understanding factors that influence STI prevalence and incidence is critical for the implementation of effective management stra... | PMC10637674 |
Supporting information | PMC10637674 | |||
Inclusivity in global research. | (DOCX)Click here for additional data file. | PMC10637674 | ||
Total proportion of women with active sexually transmitted infections (STIs) at baseline by study site. | STIS, EVENT, SEXUALLY TRANSMITTED INFECTION | The Setshaba (n = 53) study site had a greater proportion of (JPG)Click here for additional data file.(A-C). Kaplan-Meier curve showing sexually transmitted infection (STI) incidence between study site by age group over time (days). Red represents the MatCH site, green the Setshaba site. The tables show the number of i... | PMC10637674 | |
Kaplan-Meier curve showing any active sexually transmitted infection (STI) incidence between participants testing positive or negative for vaginal prostate specific antigen (PSA). | EVENT | Red represents participants positive for PSA at any visit, green indicates participants negative for PSA at all visits. The tables show the number of individuals at risk of acquiring any active STI over time. A vertical drop represents an event has occurred and a cross mark on the curves indicates that a participant ha... | PMC10637674 | |
Total proportion of women reporting ever using condoms according to prostate specific antigen (PSA) detection at baseline. | There were no significant differences in PSA detection in women who reported condom use and in women reporting no condom usage.(JPG)Click here for additional data file. | PMC10637674 | ||
Vaginal prostate specific antigen (PSA) concentrations according to reported time since last vaginal intercourse (days). | PSA concentration was significantly higher among women reporting vaginal intercourse 0–4 days compared to 8–13 days prior to the study visit (p = 0.03).(JPG)Click here for additional data file. | PMC10637674 | ||
Baseline demographic, behavioural and clinical characteristics of study by study site. | Abbreviations: (DOCX)Click here for additional data file. | PMC10637674 | ||
Baseline STI prevalence overall and by study site. | SEXUALLY TRANSMITTED INFECTION | Abbreviations: STI, sexually transmitted infection. ^tested positive for at least one STI (CT, NG, TV, MG or HSV-2). Proportions were compared using the Fishers Exact test *p<0.05 following Bonferroni correction was considered statistically significant.(DOCX)Click here for additional data file. | PMC10637674 | |
Baseline STI prevalence overall and by contraceptive group. | SEXUALLY TRANSMITTED INFECTION | Abbreviations: STI, sexually transmitted infection. ^tested positive for at least one STI (CT, NG, TV, MG or HSV-2). Proportions were compared using the Fishers Exact test *p<0.05 following Bonferroni correction was considered statistically significant.(DOCX)Click here for additional data file. | PMC10637674 | |
Three-month STI incidence overall and by study site. | *p<0.05 following Bonferroni correction was considered statistically significant.(DOCX)Click here for additional data file. | PMC10637674 | ||
Full study dataset. | (XLSX)Click here for additional data file.We thank all the women who participated in this study, the communities that supported this work and the study teams responsible for the collection, processing, storage and shipping of the samples. The contents of this paper are solely the responsibility of the authors and do no... | PMC10637674 | ||
Introduction | death | DISEASE PROGRESSION | Transgender women (TGW) remain a key population within the global HIV pandemic, with estimates that suggest that their risk of acquiring HIV is almost 50 times higher than the rest of the population [Treatment-related factors may also affect the level of adherence to antiretroviral treatment (ART). Complexity of regime... | PMC9858466 |
Methods | PMC9858466 | |||
Study setting | ’ | This study was conducted in a non-governmental organization that provides free-of-charge trans-competent and trans-affirmative HIV care in the context of clinical research in Buenos Aires, Argentina. Our trans-affirmative healthcare service includes a) use of patients’ preferred name and pronoun in interactions, clinic... | PMC9858466 | |
Study design | MAY | This was a prospective, open-label, single-arm trial of DTG-TDF/XTC. This study was designed in a national context of use of efavirenz-containing triple antiretroviral regimen with possible changes in sleep quality. This regimen could particularly affect a population with high proportions of engagement in nightly sex w... | PMC9858466 | |
Statistical analyses | SECONDARY, EVENT | Sample size was not determined in advance and a convenience sampling was conducted. All data were anonymized and analyzed using the Statistical Package for the Social Sciences (SPSS) 24 software.Descriptive statistics were presented for the primary and secondary outcomes, with median and interquartile ranges (IQRs) or ... | PMC9858466 | |
Ethics statement | TransViiV study was evaluated and approved by the institutional review board under the number FH-17. The study was carried out following the good clinical practices. All individuals provided a written informed consent before participation in any study procedure. Participation was voluntary. At each visit, participants ... | PMC9858466 | ||
Results | MAY | Between December, 2015 and May, 2018, 75 TGW were screened. Of these, 61 were enrolled and received the study treatment. Fourteen TGW (18%) were considered screening failure, being the most frequent reasons non-amplification of the genotypic test and plans to move to another city in the following year ( | PMC9858466 | |
Screening to week 48. | NOTE. | PMC9858466 | ||
Baseline clinical and psychosocial characteristics | At enrollment, most patients were asymptomatic, with 96% CDC staged as class A. Main HIV route of transmission was unprotected sexual contact. Within the baseline clinical characteristics ( | PMC9858466 | ||
Baseline characteristics of enrolled, retained, and virally suppressed HIV positive TGW. | ideation, drug abuse | Abbreviations: IQR, interquartile; pVL, plasma viral loadBaseline psychosocial characteristics show high levels of social vulnerability (e.g., 53% [n = 32] reported unstable housing; 77% [n = 47], current engagement in sex work; 61% [n = 37], incomplete high school education). Regarding mental health indicators, 26% (n... | PMC9858466 | |
Adherence, retention and viral suppression | Regarding adherence, the mean for week 24 was 86.9% and the median value was 95% (76.6–95). For week 48, the mean reported adherence was 86.3% and the median value was also 95% (76.6–95).Regarding retention, 82% were retained in the study at week 24 and this proportion decreased to 77% at week 48. Of the 47 retained pa... | PMC9858466 | ||
Survival analysis | EVENT | The starting point for this analysis is baseline visit when participants received the first treatment medication. Time between this visit and the next medication dispensed (next visit date) was calculated until the first event of no medication dispensed occurred. When this happened, the participant was considered “not ... | PMC9858466 | |
Time to last visit/medication dispensed curve. | PMC9858466 | |||
Safety and tolerability | death, Hypertriglyceridemia, cryptococcal meningitis, weight gain, appendicitis | HYPERTRIGLYCERIDEMIA, CRYPTOCOCCAL MENINGITIS, APPENDICITIS, MENINGEAL TUBERCULOSIS, INTESTINAL TUBERCULOSIS | The study drugs were well tolerated. Nine clinical AEs (grade 1: 17% [8/47] and grade 2: 2% [1/47]) were classified as possibly related to study treatment. The most frequent laboratory abnormalities were elevated aspartate transaminase/alanine transaminase (grade 2: 20% [9/45]) without an increase in bilirubin. Hypertr... | PMC9858466 |
Clinical and psychosocial factors associated with retention | As shown in | PMC9858466 | ||
Baseline clinical and psychosocial characteristics by retention status among HIV positive TGW. | * ** Fisher’s exact test is recorded. | PMC9858466 | ||
Discussion | toxicity, weight gain | This study with HIV-1-infected ART-naïve TGW showed that 77% met the protocol definition of retention (at week 48) after their initial prescription of drug regimen comprising DTG plus TDF-FTC or 3TC. Likewise, 72% and 97% of participants showed viral suppression at week 48 in ITT and per-protocol analyses, respectively... | PMC9858466 | |
Limitations | STILL | The present study has some limitations. Firstly, our findings cannot be generalized to all HIV positive TGW in Argentina. A small non-probability sample was enrolled, limiting generalizability of results. Still, the final sample showed sociodemographic characteristics that are similar to nationwide studies with non-cli... | PMC9858466 | |
Conclusion | In this study, DTG-based treatment delivered by a trans-competent team in a trans-affirmative service was safe and well tolerated by TGW and associated with high retention, high adherence and high viral suppression at 48 weeks among those being retained. Thus, results support the use of DTG-based treatments in this pop... | PMC9858466 | ||
Supporting information | PMC9858466 | |||
Original protocol Spanish version. | (PDF)Click here for additional data file. | PMC9858466 | ||
Original protocol English version. | (PDF)Click here for additional data file. | PMC9858466 | ||
Minimal anonymized data set. | Travestis | (XLSX)Click here for additional data file.The authors would like to thank all the participants and organizations that work with us, and that collaborate in improving the health of the trans population: Asociación de Travestis, Transexuales y Transgéneros de Argentina (A.T.T.T.A), Asociación Civil Hotel Gondolin and Cas... | PMC9858466 | |
Background and purpose | aneurysms, intracranial aneurysms | ANEURYSMS, INTRACRANIAL ANEURYSMS | The CATCH (Coil Application Trial in China) trial was designed to assess the safety and efficacy of the Numen Coil Embolization System in the treatment of intracranial aneurysms in comparison with the Axium coil (ev3/Medtronic). Although the endovascular treatment of small (< 5 mm) intracranial aneurysms has been repor... | PMC10276443 |
Materials and methods | aneurysm occlusion, intracranial aneurysms | SECONDARY, RECURRENCE, INTRACRANIAL ANEURYSMS | A randomized, prospective, multicenter trial was conducted at ten centers throughout China. Enrolled subjects with small intracranial aneurysms were randomly assigned to receive treatment with the Numen Coil or the Axium coil. The primary outcome was successful aneurysm occlusion at the 6-month follow-up. In contrast, ... | PMC10276443 |
Results | aneurysm occlusion | COMPLICATIONS | A total of 124 patients were enrolled in the study. Overall, 58 patients were assigned to the Numen group, and 66 were assigned to the Axium group. At the 6-month follow-up, the successful aneurysm occlusion rate was 93.1% (54/58) in the MicroPort NeuroTech group and 97.0% (64/66) in the Axium group, with a common odds... | PMC10276443 |
Conclusions | INTRACRANIAL ANEURYSMS | Compared with the Aixum coil, the Numen coil is safe and effective in treating small intracranial aneurysms. | PMC10276443 | |
Trial registration | (13/12/2016, NCT02990156) | PMC10276443 | ||
Keywords | PMC10276443 | |||
Introduction | thrombosis, aneurysm, aneurysms, occlusion, ischemic stroke, unruptured aneurysms, disability | THROMBOSIS, RECURRENCE, ANEURYSM, ANEURYSMS, ISCHEMIC STROKE, INTRACRANIAL ANEURYSMS | Due to the unique structures of small aneurysms, technical difficulties exist in the treatment of small aneurysms, including ruptured and unruptured aneurysms. Compared with clipping, intravascular embolization has lower mortality and disability rates [In recent years, with the development of manufacturing technology, ... | PMC10276443 |
Materials and methods | PMC10276443 | |||
Study design | aneurysm rupture, aneurysm, aneurysms | ANEURYSM, RECRUITMENT, ANEURYSMS, ANEURYSM RUPTURED, COMPLICATIONS, INTRACRANIAL ANEURYSMS | This study is a subgroup analysis of Catch data obtained from a prospective, multicenter, open-label, randomized controlled trial that includes patients treated with the Numen and Axium coil. The CATCH clinical trial includes patients treated with the Numen or Axium coil starting in August 2017 and concluding in Decemb... | PMC10276443 |
Participants | aneurysm, intracranial lesion, unruptured intracranial aneurysm, cerebral arteriovenous malformation, stenosis | ANEURYSM, STENOSIS | At each clinical center, eligible patients were screened if they met any of the following criteria: The patient was aged 18 to 80; ruptured (World Federation of Neurologic Societies grade < IV) or unruptured intracranial aneurysm, as demonstrated by computed tomography angiography (CTA), magnetic resonance angiography ... | PMC10276443 |
Randomization and masking | rupture | All eligible patient allocations were randomized at a 1:1 ratio based on an interactive Web response system. Information technology specialists developed the system from an independent clinical research organization. The online central randomization method ensured that the allocation was concealed. In addition, minimiz... | PMC10276443 | |
Procedures | aneurysm, wide-necked aneurysms | SURGICAL COMPLICATIONS, ANEURYSM | All recruited participants performed routine preoperative examinations to reduce surgical complications. All procedures were performed under general anesthesia and via a transfemoral approach. After sheath placement, systematic heparinization was individually administered to maintain an activated clotting time of 250–3... | PMC10276443 |
Clinical and radiological assessments | rupture, aneurysm occlusion, aneurysm | EVENTS, EVENTS, ANEURYSM, COMPLICATIONS | All participants underwent preoperative preparation, including clinical examination and angiographic assessment of the target aneurysm. Before randomization, the parameters collected included age, sex, and rupture status. In addition, other baseline data were obtained on aneurysm size and location. After surgery, the f... | PMC10276443 |
Outcomes | aneurysm rupture, aneurysm occlusion, aneurysm | RECURRENCE, ANEURYSM, ADVERSE EVENTS, ISCHEMIC STROKE, SECONDARY, ANEURYSM RUPTURED | The trial’s primary outcome was the proportion of participants with successful aneurysm occlusion at the 6-month follow-up. Members of the independent core laboratory reviewed the digital copies of the imaging data and assessed the degree of aneurysm occlusion. Successful aneurysm occlusion was defined as Raymond class... | PMC10276443 |
Statistical analysis | ADVERSE EVENTS, SECONDARY | The baseline characteristics of patients between groups were compared to verify intergroup differences. Medians with interquartile ranges were used for continuous variables, and proportions were used for categorical variables. The t-test or Mann-Whitney U test was used for continuous variables, and the χ2 test or Fishe... | PMC10276443 | |
Results | PMC10276443 | |||
Baseline results | ruptured aneurysm, aneurysm, aneurysms | RECRUITMENT, RUPTURED ANEURYSM, ANEURYSM, ANEURYSMS | Three hundred and fifty patients were recruited into the CATCH trial between April 2017 and October 2017 under randomization. Recruitment was stopped after the target number of patients had been recruited. The data of 140 patients whose aneurysms were smaller than 5 mm were extracted from the CATCH trial. The 140 patie... | PMC10276443 |
Numen arm | aneurysm, aneurysms | RUPTURED ANEURYSMS, ANEURYSM, ANEURYSMS | Among patients allocated to the Numen group, the mean age was 56 ± 9.89. Twenty (34.48%) patients were male, while 38 (65.52%) were female. The mean aneurysm size was 3.85 ± 0.60 mm. Fifty-seven aneurysms (98.28%) were located in the anterior circulation, and 1 (1.72%) was found in the posterior circulation. Twelve pat... | PMC10276443 |
Axium arm | aneurysm, aneurysms | RUPTURED ANEURYSMS, ANEURYSM, ANEURYSMS | Among patients allocated to the Axium group, the mean age was 55 ± 9.57 years. Twenty-six (39.39%) patients were male, while 40 (60.61%) were female. The mean aneurysm size was 3.83 ± 0.82 mm. Sixty-five aneurysms (98.48%) were located in the anterior circulation, and 1 (1.52%) was in the posterior circulation. Ninetee... | PMC10276443 |
Primary and secondary outcomes | thrombosis, allergic, fever, intraoperative ischemic stroke, stroke, vomiting,, ischemic stroke, headache | THROMBOSIS, ADVERSE EVENTS, STROKE, ISCHEMIC STROKE, SECONDARY, ARTERY OCCLUSION, EVENTS, COMPLICATIONS | Treatment and follow-up details are shown in Table
Primary and secondary outcomes evaluationData are No. (%). P < 0.05 was considered statistically significantStatistical analysis showed that complications were comparable between the groups. Overall, general adverse events occurred in 9/58 patients (15.5%) in the Nume... | PMC10276443 |
Discussion | aneurysm, Intraoperative aneurysm rupture, aneurysms, Numen, small aneurysms, thrombus, saccular aneurysms, unruptured aneurysms, intracranial aneurysms | ANEURYSM, COMPLICATION, ANEURYSMS, THROMBUS, SACCULAR ANEURYSMS, EVENTS, COMPLICATIONS, INTRACRANIAL ANEURYSMS | Although several studies have been conducted to evaluate the safety and efficacy of the endovascular treatment of small intracranial aneurysms, randomized trials are still lacking. We extracted data from the CATCH trial and found that endovascular coiling techniques for treating small intracranial aneurysms are safe an... | PMC10276443 |
Acknowledgements | We gratefully acknowledge Prof. Jielai Xia (Department of Medical Statistics, Fourth Military Medical University, Xi An, China) for providing guidance on the various statistical methods used in this study. We are grateful to all principal investigators and delegated physicians who enrolled the required participants in ... | PMC10276443 | ||
Author contributions | Conceptualization: Sheng Guan; Writing original draft preparation: Yazhou Jin; Methodology: Xinbin Guo; Formal analysis and investigation: Tao Quan; Resources: Rui Zhao, Tianxiao Li, Zhenwei Zhao, Hua Yang, Xingen Zhu, Guobiao Liang, Bing Leng, Xin Wu, Yang Wang; Supervision: Sheng Guan; Writing, review and editing: Sh... | PMC10276443 | ||
Funding | The trial was funded by the National Key R&D Program of China during the 13th Five-year Plan Period (Grant No. 2016YFC1300700), the National Key Clinical Specialty Construction Project, and the Project of the Shanghai Science and Technology Commission (Grant No. 17441907000) while being sponsored by unrestricted grants... | PMC10276443 | ||
Data availability | The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request. | PMC10276443 | ||
Declarations | PMC10276443 | |||
Competing interests | The authors declare no competing interests. | PMC10276443 | ||
Ethics approval and consent to participate | The study was approved by the ethics review board of Zhengzhou University First Affiliated Hospital (2017-09) in accordance with the Declaration of Helsinki. Written informed consent was obtained from all individual patients included in the study. | PMC10276443 | ||
Consent for publication | Not applicable. | PMC10276443 | ||
Abbreviations | EVENTS | Coil Application Trial in ChinaClinical Events CommitteeFull Analysis SetPer-Protocol Set | PMC10276443 | |
References | PMC10276443 | |||
Objectives | SURGICAL COMPLICATIONS | To compare hearing outcome and surgical complications between endoscopic classic and reversal stapedotomies. | PMC10313534 | |
Patients and methods | otosclerosis | SURGICAL COMPLICATIONS, OTOSCLEROSIS | A prospective single blinded randomized clinical study carried out on 60 patients with otosclerosis who were randomized into two groups; each containing 30 patients. Patients in group 1 underwent endoscopic classic stapedotomy. Patients in group 2 underwent endoscopic reversal stapedotomy. Both groups were compared as ... | PMC10313534 |
Results | SURGICAL COMPLICATIONS | The difference in the hearing outcome between the two groups was statistically non-significant. Post-operative closure of the air bone gap (ABG) within 10 dB was attained in 76.67% and 80% of patients in groups 1 and 2, respectively. The differences in the surgical complications between the two studied groups were stat... | PMC10313534 | |
Conclusion | SURGICAL COMPLICATIONS | Endoscopic classic and reversal stapedotomies are comparable to each other as regards hearing outcome and surgical complications. The authors recommend further studies with relatively larger sample size. | PMC10313534 |
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