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Surfactant phospholipid measurements | Surfactant phosphatidylcholine (PC) was extracted from tracheal aspirate samples and analysed over time. The surfactant group able to augment total aspirate PC pool from 44.7% at t = 0 h to a maximum value of 80.2% after nebulisation. This was evident for both surfactant groups (cohort 1 + 2 and cohort 2 + 3). There wa... | PMC10684757 | ||
Discussion | hypoxic respiratory failure, RDS, APACHE-II, ARDS | ADVERSE EVENTS, NEONATAL RESPIRATORY DISTRESS SYNDROME, DISEASE, HYPOXIC RESPIRATORY FAILURE, SECONDARY, ARDS | This is a pilot, randomised, unblinded, two-centre, controlled study evaluating the feasibility, efficacy, and safety of delivering nebulized surfactant for COVID-19 patients with acute severe hypoxic respiratory failure. Breath synchronised exogenous surfactant delivery is feasible, and surfactant phospholipid composi... | PMC10684757 |
Conclusions | This phase 2 randomised controlled trial of natural nebulized surfactant using novel breath-synchronised delivery combined with a photo defined aperture plate (PDAP) vibrating mesh nebulizer in mechanically ventilated patients with severe COVID-19 is feasible and safe. However, the trial did not demonstrate improvement... | PMC10684757 | ||
Supplementary Information | The online version contains supplementary material available at 10.1038/s41598-023-47672-x. | PMC10684757 | ||
Acknowledgements | UHS | We would like to thank our trial coordinator Josune Olza Meneses, Trial Steering Committee (Stephen Brett, Luigi Camporota, Kevin Dhaliwal, Murali Shyamsundar, and Sharon Davies-Dear) and DSMB committee members (Monty Mythen, Charlotte Summers, and Isobel Reading) the critical care research nursing team from UCLH and U... | PMC10684757 | |
Author contributions | RECRUITMENT | A.D., H.W.C., J.B.F., J.M., R.D., A.D.P., M.P.W.G. contributed to the study conception and design. DP coordinated the study. A.D., H.W.C., D.B., L.M., M.P.W.G. contributed to the recruitment of study participants. A.D., H.W.C., D.B., H.M., T.H., M.F., A.D.P., M.P.W.G contributed to acquisition, analysis, and interpreta... | PMC10684757 | |
Funding | CRF | CRF | The COVSurf trial is funded by the Bill and Melinda Gates Foundation (INV-016631). Supported by NIHR Southampton Biomedical Research Centre (BRC) and NIHR Southampton Clinical Research Facility (CRF). MPWG is supported by the NIHR Senior Investigator Award scheme. | PMC10684757 |
Data availability | The datasets used and analysed during the current study are available from the corresponding author on reasonable request. | PMC10684757 | ||
Competing interests | Dr Fink is CSO of Aerogen Pharma Corporation and all other authors declare no conflicts of interest. | PMC10684757 | ||
References | PMC10684757 | |||
Background | fractures, infections, IBD | INFECTIONS, SKIN CANCERS, INFLAMMATORY BOWEL DISEASE | Patients with inflammatory bowel disease (IBD) are at increased risk of infections, bone fractures, and skin cancers. | PMC10483303 |
Objective | We developed preventive health videos using a patient-centered approach and tested their impact on preventive health uptake. | PMC10483303 | ||
Methods | IBD | INFLUENZA | Five animated videos explaining preventive health recommendations in IBD were iteratively developed with patient-centered focus groups and interviews. A randomized controlled trial was then conducted in a web-based IBD cohort to test the impact of video- versus text-based educational interventions. The primary outcome ... | PMC10483303 |
Results | IBD | INFLUENZA | Five animated videos were developed with patient input. A total of 1056 patients with IBD were then randomized to receive the video (n=511) or text-only (n=545) interventions; 55% (281/511) of the video group and 57% (311/545) of the text-only group had received their influenza vaccine in the prior year. Immediately af... | PMC10483303 |
Conclusions | IBD | INFLUENZA | The proportion of patients receiving the influenza vaccine was high in both groups, but there was no difference in receipt of or in the intention to receive preventive health recommendations by type of messaging. Notably, a portion of patients in both groups had intended to be vaccinated but did not ultimately receive ... | PMC10483303 |
Trial Registration | ClinicalTrials.gov NCT05997537; https://clinicaltrials.gov/ct2/show/NCT05997537 | PMC10483303 | ||
Introduction | ulcerative colitis, cancer, Crohn disease, UC, IBD | INFLAMMATORY BOWEL DISEASES, ULCERATIVE COLITIS, CANCER, INFLAMMATORY DISORDER, CROHN DISEASE | Inflammatory bowel diseases (IBD), including both Crohn disease (CD) and ulcerative colitis (UC), are chronic, relapsing inflammatory disorders of the gastrointestinal tract associated with substantial morbidity [Preventive health guidelines in IBD emphasize the importance of appropriate vaccination, bone health preven... | PMC10483303 |
Methods | PMC10483303 | |||
Patient Focus Groups | zoster, skin cancer, IBD | ZOSTER, INFLAMMATORY BOWEL DISEASE, DISEASE, SKIN CANCER, DISEASE DIVERS, INFLUENZA | Scripts were developed for 5 preventive health educational videos (influenza, pneumococcal, and zoster vaccines; bone health; and skin cancer screening) based on best practice guidelines and expert input. To understand patients’ needs and expectations for the videos, we performed two 90-minute focus groups with patient... | PMC10483303 |
Video Development | Based on the insights from the focus groups, the video scripts were adjusted and 5 video prototypes were developed. In 5 semistructured interviews, patient feedback was sought regarding video duration, information visualization, terminology, clarity and consistency of language, and graphics before finalizing the videos... | PMC10483303 | ||
Message Development | IBD | DISORDERS, DISEASE, COMPLICATIONS | Text-only messaging reminders included information on indications for vaccination or health screening, complications of these disorders within patients with IBD, recommendations for vaccination or health preventive activities within the IBD population, and references for further reading from the Centers for Disease Con... | PMC10483303 |
Ethics Approval | The study was reviewed and approved by the institutional review board of Cedars-Sinai Medical Center and University of North Carolina (IRB 19-1607 and 10-0184). All patients provided their informed consent, indicating their willingness to participate in this study. All data are stored and deidentified. Study participan... | PMC10483303 | ||
Randomized Controlled Trial | IBD | INFLUENZA | We next conducted a randomized controlled trial to compare the animated video content (active intervention) with a text-based preventive health reminder for influenza vaccination (control intervention) within the IBD Partners Patient Powered Research Network (PPRN) [Patients who agreed to participate were assigned to r... | PMC10483303 |
Sample Size Calculation | IBD | INFLUENZA | Given the baseline rate of influenza vaccination of 65% in the IBD Partners cohort [ | PMC10483303 |
Data and Statistical Analysis | zoster | REGRESSION, ZOSTER, INFLUENZA | We used descriptive statistics to define the characteristics of the study cohort. Continuous variables are described as medians and IQRs. Categorical variables are defined as proportions. The 2 study arms were compared using 2-sided tests of statistical significance (Stratified analyses were used to assess for interven... | PMC10483303 |
Discussion | Skin Cancer, Colitis, Crohn, Pneumonia, IBD | SKIN CANCER, COLITIS, SHINGLES, INFLUENZA, CROHN, PNEUMONIA, INFLUENZA | In this study, we developed IBD-focused animated videos for preventive health education with direct patient input and tested their efficacy in a randomized controlled trial using a large web-based cohort. We did not find a difference in the immediate postintervention intention to receive preventive health services betw... | PMC10483303 |
Abbreviations | COLITIS | inflammatory bowel diseaseCrohn diseasePatient Powered Research Networkulcerative colitis | PMC10483303 | |
Data Availability | IBD | Deidentified data are stored at the University of North Carolina for the IBD Partners cohort. | PMC10483303 | |
Background | UTERINE ATONY | Prior studies have shown that, when administered as an intravenous bolus to prevent uterine atony, prophylactic phenylephrine infusion increased the dose requirement of oxytocin and second-line uterotonics. For the prevention of uterine atony, oxytocin should be delivered by continuous infusion. Here, we aimed to deter... | PMC10698888 | |
Methods | blood loss | REGRESSION, BLOOD LOSS | In this prospective randomized double-blinded dose-finding study, one hundred patients were divided into four groups to receive 2.5, 5.0, 7.5, or 10 IU/h oxytocin infusion, after the umbilical cord was clamped during the study period. The uterine tone was evaluated and defined as either adequate or inadequate. Probit r... | PMC10698888 |
Results | uterine atony | UTERINE ATONY | The estimated ED50 and ED90 values of the oxytocin infusion doses for the prevention of uterine atony were 1.9 IU/h (95% CI -4.6-3.8) IU/h and 9.3 IU/h (95% CI 7.3–16.2) IU/h, respectively. Across groups, there was a significant linear trend between the infusion dose and the percentage of patients who required addition... | PMC10698888 |
Conclusion | uterine atony | UTERINE ATONY | Under the conditions of this study, the ED90 of oxytocin infusion for the prevention of uterine atony was 9.3 IU/h, which is higher than the current recommendation. This finding is helpful for clinical practice, because of the routine use of phenylephrine in cesarean delivery. Further studies are needed to determine th... | PMC10698888 |
Trial registration | The study was registered on the Chinese Clinical Trial Register (register no. | PMC10698888 | ||
Keywords | PMC10698888 | |||
Background | nausea, vomiting, hypotension, PPH, uterine atony | POSTPARTUM HAEMORRHAGE, UTERINE ATONY | Postpartum haemorrhage (PPH) continues to be a significant contributor to maternal mortality. Oxytocin has been commonly used for the prevention of PPH. The optimal dosage and administration method of oxytocin utilized in clinical practice remains uncertain. In the past, 5 international unit (IU) oxytocin used to be a ... | PMC10698888 |
Methods | PMC10698888 | |||
Ethics | MAY | The present study was approved by the Ethical Committee of Hangzhou City Linping District Maternal and the Child Care Hospital, Hangzhou, China (approval no. LLSC-KYKT-2022-0007-A, Chairperson: Prof. Yue-Jian Shen) on March 23, 2022. The study was registered on the Chinese Clinical Trial Register (register no. ChiCTR22... | PMC10698888 | |
Design | This is a prospective randomized double-blinded dose-finding study. | PMC10698888 | ||
Patients and setting | obesity | OBESITY | One hundred patients with singleton, full-term pregnancies, scheduled for elective cesarean delivery, were enrolled in this study. Exclusion criteria were: patients with American Society of Anesthesiologists physical status ≥ III, obesity (body mass index, BMI > 35 kg/m | PMC10698888 |
Study protocol | Bradycardia, bradycardia, loss of pinprick sensation, Hypertension, hypotension | HYPERTENSION, UTERINE ATONY | Based on a randomized number sheet generated by a research assistant using an online randomization generator (None of the patients received any premedication. In the waiting room, peripheral access was created using an 18 G intravenous cannula inserted into the left upper limb vein. Upon arrival at the operating room, ... | PMC10698888 |
Measurements | bradycardia, nausea, tachycardia, blood loss, chest pain, hypotension, shivering | BLOOD LOSS, SECONDARY, HYPERTENSION | The primary outcome of the current study was the adequacy of UT during the study period. The UT was ranked as most satisfied (touched as forehead), satisfied (touched as tip of nose), dissatisfied (touched as lip), and assessed by the obstetrician, who did not aware of patients’ group, at 5-min intervals till to close ... | PMC10698888 |
Sample size calculation | Sample size was calculated using the Cochran-Armitage Test for the trend in proportions using PASS®, (Version 11.0.7, NCSS, LLC, Kaysville, UT, USA), in accordance with the primary outcome of this study. According to a pilot study for the 4 groups with infusion doses of 2.5, 5.0, 7.5, and 10 IU/h, the proportions of ad... | PMC10698888 | ||
Statistical analysis | ASD | Analyses were performed using IBM SPSS Statistics for Windows version 22.0 (IBM Corp, Armonk, NY, USA), GraphPad Prism version 5.0 (GraphPad Software Inc., San Diego, CA, USA), and Microsoft Excel (Microsoft Corporation, Redmond, WA, USA). We assessed the distribution of the continuous variables using graphical display... | PMC10698888 | |
Discussion | flushing, tachycardia, blood loss, chest pain, labor, hypotension, nausea,, PPH, depression, headache, uterine atony | REGRESSION, CONTRACTION, BLOOD LOSS, UTERINE ATONY | In this prospective dose-finding study, we have shown that, in women receiving 0.5 μg/kg/min phenylephrine to prevent post-spinal hypotension during elective cesarean delivery, the ED90 of oxytocin to prevent uterine atony was 9.3 IU/h. This value is significantly higher than the recommended dose by an international co... | PMC10698888 |
Conclusions | uterine atony | UTERINE ATONY | In summary, under the conditions of this study, the ED90 of oxytocin infusion for the prevention of uterine atony was 9.3 IU/h following an initial bolus of 3 IU, which is higher than the current recommendations. This finding is helpful for clinical practice, because phenylephrine is routinely used in cesarean delivery... | PMC10698888 |
Acknowledgements | We gave our sincerest thanks to all the staff in the operating theater and all obstetric staff involved for their kind help in study delivery. | PMC10698888 | ||
Authors’ contributions | XQ.J and XD.H wrote the main manuscript text and YH.S prepared Figs. | PMC10698888 | ||
Funding | None. | PMC10698888 | ||
Availability of data and materials | All data generated or analysed during this study are included in this published article. | PMC10698888 | ||
Declarations | PMC10698888 | |||
Ethics approval and consent to participate | MAY | The Ethical Committee of Hangzhou City Lin-Ping District Maternal and Child Care Hospital, Hangzhou, China (Chairperson Prof Ying-hao Zhang) reviewed and approved this study involving patients on 11 May 2022 (LLSC-KYKT-2022-0007-A). The patients provided their written informed consent to participate in this study. | PMC10698888 | |
Consent for publication | Not applicable. | PMC10698888 | ||
Competing interests | The authors declare no competing interests. | PMC10698888 | ||
References | PMC10698888 | |||
1. Introduction | death, anxiety, fatigue, cancer, depression, Cancer | DISEASE, CANCER, ADVANCED CANCER, CANCER | The experience of caregiver burden among family members of patients with advanced cancer is a common problem. The aim of this study was to determine whether the burden may be alleviated by means of a therapeutic approach based on self-chosen music. This randomised controlled trial (ClinicalTrials.gov, NCT04052074. Regi... | PMC10002131 |
2. Materials and Methods | PMC10002131 | |||
2.1. Participants | hearing deficiency | ADVANCED CANCER, RECRUITMENT | A total of 82 caregivers participated in the present study: 41 in the intervention group and 41 in the control group. The criteria for inclusion were that the participant should be a family caregiver of a patient with advanced cancer in home palliative care, over 18 years of age, and not have a severe hearing deficienc... | PMC10002131 |
2.2. Design | ADVANCED CANCER | The study is a randomised, double-blind, multicentre, controlled clinical trial of family caregivers of patients with advanced cancer receiving home palliative care, performed at six primary care centres within the Malaga-Guadalhorce Health District, Andalusia, Spain.The present study was approved by the Research Ethic... | PMC10002131 | |
2.3. Measures | The dependent measure considered in the present study was the burden experienced by the caregiver, as assessed by the Case Management Nurse from the corresponding health centre, during a home visit using the Caregiver Strain Index (CSI). This outcome was assessed by using a CSI questionnaire, which has proven to be rel... | PMC10002131 | ||
2.4. Procedure | The independent variable considered was that of listening to self-chosen music as a complementary intervention. Prior to the intervention, all caregivers (both in the control group and the intervention group) received conventional health care under the same conditions, including basic therapeutic education for palliati... | PMC10002131 | ||
2.5. Statistical Analyses | Bivariate analyses were performed to detect any demographic or other baseline differences between the control and intervention groups, using the non-parametric Mann–Whitney test, the Chi-square test, or Fisher’s exact test. The CSI differences were analysed by applying a 2 × 2 mixed factorial analysis of variance (ANOV... | PMC10002131 | ||
3. Results | ADVERSE EVENTS | The bivariate analyses revealed no significant differences in sociodemographic or other baseline data between the control and intervention groups (There was a significant group x moment interaction (F (1, 80) = 9.30, During the intervention, none of the participants presented any adverse events. | PMC10002131 | |
4. Discussion | cancer, depression, anxiety | CANCER, ADVANCED CANCER | Caregivers are at high risk for stress, poor quality of life, and burnout. To address these concerns, increasing attention has been paid to using music in clinical settings such as cancer centres, hospices, and palliative programmes [According to our results, an earlier clinical trial reported that listening to pre-rec... | PMC10002131 |
5. Limitations | depression, anxiety | EVENT | The present study is subject to some limitations that must be acknowledged. Firstly, the participants were recruited at urban public health centres, and their characteristics might differ from those of caregivers attending private health centres or residents of other geographical areas. Consequently, the generalisation... | PMC10002131 |
Author Contributions | M.Á.V.-S. and C.C. contributed to the fundraising, conceptualisation, methodological design, software application, formal analysis, background research, data curation, drafting, reviewing and editing of this study. I.V.-C. contributed to the fundraising, project management, conceptualisation, methodological design, bac... | PMC10002131 | ||
Institutional Review Board Statement | RECRUITMENT | The study was conducted in accordance with the Declaration of Helsinki, and the clinical trial protocol was reviewed and approved by the Research Ethics Committee of the Province of Malaga, on 28 March 2019 (File number: AP-0157-2018). The study is registered at ClinicalTrials.gov, NCT04052074. Registered 9 August 2019... | PMC10002131 | |
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC10002131 | ||
Data Availability Statement | Study data are available on reasonable request to the corresponding author. | PMC10002131 | ||
Conflicts of Interest | The authors declare no conflict of interest. | PMC10002131 | ||
References | cancer | CANCER, RECRUITMENT | Flow chart for recruitment and procedures of the study.Audio content for the intervention and control groups of family caregivers.Bivariate analysis of socio-demographic data for caregivers of palliative cancer patients.The results are shown as mean ± standard deviation and as number of participants (percentage) for fr... | PMC10002131 |
Abstract | Kei Kawana and Osamu Kobayashi contributed equally to this work. | PMC10748578 | ||
Background | Although many human papillomavirus (HPV)–targeted therapeutic vaccines have been examined for efficacy in clinical trials, none have been translated into clinical use. These previous agents were mostly administered by intramuscular or subcutaneous injection to induce systemic immunity. We investigated the safety and th... | PMC10748578 | ||
Methods | CERVICAL INTRAEPITHELIAL NEOPLASIA | In a double-blind, placebo-controlled, randomized trial, a total of 165 patients with HPV-16–positive high-grade cervical intraepithelial neoplasia 2 and 3 were assigned to orally administered placebo or low, intermediate, or high doses of IGMKK16E7 ( | PMC10748578 | |
Results | REGRESSION, ADVERSE EVENTS | In per-protocol analyses, histopathological regression to normal (complete response) occurred in 13 (31.7%) of 41 high-dose recipients and in 5 (12.5%) of 40 placebo recipients (rate difference = 19.2, 95% confidence interval [CI] = 0.5 to 37.8). In patients positive for HPV-16 only, the clinical response rate was 40.0... | PMC10748578 | |
Conclusion | CERVICAL INTRAEPITHELIAL NEOPLASIA | This trial demonstrates safety of IGMKK16E7 and its efficacy against HPV-16–positive cervical intraepithelial neoplasia 2 and 3. IGMKK16E7 is the first oral immunotherapeutic vaccine to show antineoplastic effects. | PMC10748578 | |
Trial registration | CIN | REGRESSION, CERVICAL CANCER, CIN | jRCT2031190034.Although cervical cancer risk has decreased in response to prophylactic human papillomavirus (HPV) vaccines, many low- and middle-income countries, especially in Eastern Mediterranean, Southeast Asian, and Western Pacific regions, lack robust implementation of prophylactic vaccination, and need for addit... | PMC10748578 |
Methods | PMC10748578 | |||
Trial oversight | The mucosal immunotherapy using HPV type 16 E7–expressing | PMC10748578 | ||
Patients | allergies | CIN 2, INVASIVE CANCER, PATHOLOGY, ALLERGIES | Patients with pathologically determined CIN 2 or 3 who were positive for HPV-16 by HPV genotyping using exfoliated cervical cells were eligible for enrollment. A central review for pathological diagnosis was set up to exclude bias in pathology diagnosis between the 4 centers and among pathologists. Two pathologists spe... | PMC10748578 |
Trial procedures | CIN | CIN 3, CIN | Participants were randomly assigned in a 1:1:1:1 ratio to either the low-dose, intermediate-dose, or high-dose IGMKK16E7 groups or the placebo group. We calculated sample size based on the results of the GLBL-101c clinical study targeting CIN 3 (Random assignment was performed with the use of a web-based system by mini... | PMC10748578 |
Clinical samples and biological assays | Cervices were sampled before registration and at 16 and 24 weeks after the first study dose in outpatient clinics. Peripheral blood for immunological evaluation and exfoliated cervical cells for cytological and virological evaluation were sampled at study weeks 9, 16, and 24. Peripheral blood monocytes were isolated wi... | PMC10748578 | ||
Outcomes | REGRESSION, ADVERSE EVENT, CIN 1 | Primary outcomes included histopathological regression to normal (complete response) or CIN 1 (partial response) at week 16 and IGMKK16E7 safety. Secondary outcomes included histopathological regression at week 24, immunological response, cytological regression, and viral clearance. All safety outcomes were based on ad... | PMC10748578 | |
Statistical analysis | CERVICAL INTRAEPITHELIAL NEOPLASIA, CIN 1, HSIL, REGRESSION, EVENTS, HIGH-GRADE SQUAMOUS INTRAEPITHELIAL LESION | The study was designed to have 80% power to detect a 30%, 20%, and 10% difference in the rates of pathological complete regression or complete regression plus partial regression between high-, intermediate-, low-dose, and placebo groups, respectively. Because spontaneous regression to normal or CIN 1 with placebo was e... | PMC10748578 | |
Results | PMC10748578 | |||
Characteristics of the patients | human papillomavirus-16 | PATHOLOGY, CERVICAL INTRAEPITHELIAL NEOPLASIA | From June 15, 2019, to December 30, 2021, a total of 283 patients were enrolled at 4 centers; 165 eligible patients were randomly assigned to the high-dose (n = 43), intermediate-dose (n = 40), and low-dose (n = 41) groups, and 40 patients were assigned to the placebo group for the full analysis set (Patients’ enrollme... | PMC10748578 |
Clinical outcome | CIN | REGRESSION, CERVICAL INTRAEPITHELIAL NEOPLASIA, CIN | In per-protocol set analysis of 159 patients, histopathological regression to normal (complete response) occurred in 7 (17.1%) of 41 high-dose recipients and 4 (10.0%) of 40 placebo recipients at week 16 (rate difference = 7.1, 95% confidence interval [CI] = −9.4 to 23.9), while complete response occurred in 13 (31.7%)... | PMC10748578 |
Immunological analysis | REGRESSION, DISEASE | To examine whether clinical efficacy could be linked to immunological response, we assessed the association between clinical response and the number of HPV-16 E7–specific, IFN-γ–producing cells (spot-forming cells numbers) among peripheral blood monocytes at the study endpoint. The measured spot-forming cells among per... | PMC10748578 | |
Safety | ADVERSE EVENT | In the safety analysis set of 164 patients, at least 1 adverse event occurred in 21 (48.8%) of 43 high-dose, 21 (52.5%) of 40 intermediate-dose, 20 (48.8%) of 41 low-dose, and 19 (46.3%) of 41 placebo recipients questioned 24 weeks after the first dose (percentage point difference between high dose and placebo = 2.5, 9... | PMC10748578 | |
Discussion | high-grade precancerous cervical lesions, precancerous cervical disease, CIN, HPV-16 infection | ADVERSE EVENTS, CIN 2, CIN 1, CIN, CIN 3, REGRESSION, REGRESSION | We found that oral administration of IGMKK16E7 in patients with HPV-16–positive CIN 2 and 3 drove histopathological regression to normal (complete response) at 24 weeks after the first dose. Linear complete response dose responses for IGMKK16E7 were clearly demonstrated in both overall and subgroup analyses. Difference... | PMC10748578 |
Supplementary Material | Click here for additional data file. | PMC10748578 | ||
Acknowledgements | We thank the patients who participated in this clinical trial; Chisato Nagata, Tomotaka Sobue, and Yuki Sato for supervising the implementation of the study; Shinobu Masuda and Yoko Nakanishi for immunohistochemistry; Toshiharu Yasugi, Yoko Hasumi, and Takahide Arimoto for service on the Safety Monitoring Committee; Ka... | PMC10748578 | ||
Data Availability | Participant data can be shared with outside collaborators for research to understand more about the clinical efficacy and safety of the IGMKK16E7 and immune response to the vaccine obtained from the MILACLE study. These data are available online at | PMC10748578 | ||
Author contributions | Kei Kawana, MD, PhD (Conceptualization; Funding acquisition; Investigation; Methodology; Project administration; Validation; Visualization; Writing—original draft), Shizunobu Igimi, PhD (Conceptualization; Resources; Supervision; Writing—original draft), Daisuke Aoki, MD, PhD (Conceptualization; Investigation; Project ... | PMC10748578 | ||
Funding | Funded by GLOVACC Co Ltd and the Japan Agency for Medical and Development (AMED). | PMC10748578 | ||
Conflicts of interest | Dr Kawana reports receiving lecture fees and travel support from MSD and grant support from the Japan Agency for Medical and Development (AMED) and GLOVACC Co Ltd; Dr Uemura, lecture fees from Chugai and Eli Lilly; Dr Igimi, patent indemnification from National Institute of Health Sciences and grant support from GLOVAC... | PMC10748578 | ||
References | PMC10748578 | |||
Summary | PMC9912700 | |||
Background | Mouthwashes containing oral antiseptics or enzymes are suggested suitable for controlling biofilm accumulation in patients with fixed appliances and thereby limiting unwanted side effects during the orthodontic treatment. | PMC9912700 | ||
Objectives | To evaluate the effect of an enzyme-based mouthwash on the amount of dental biofilm and the composition of the salivary microbiome in patients undergoing treatment with fixed orthodontic appliances. | PMC9912700 | ||
Trial design | Randomized double-blind placebo-controlled trial. | PMC9912700 |
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