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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Statistical analysis | SD | Pharmacokinetic parameters were determined by non-compartmental analysis using PK solutions software, version 2.0 (Summit Research Services). The maximum concentration of four targeted compounds (CStatistical analysis was performed using STATA statistical software (StataCorp, USA). Continuous data were illustrated as m... | PMC9924185 | |
Data availability | The datasets generated and/or analyzed during the present study are not publicly available due to ethical concerns and confidentiality agreements but are available from the corresponding author on reasonable request that needs a consensus from colleagues. | PMC9924185 | ||
Results | PMC9924185 | |||
Screening and identification of the analyte and metabolite profiling using LC-QTOF/MS analysis | The compound profiling after oral administration of Compound screening and identification after oral administration of *The tentative conjugated of AP3 sulfate and AP6 sulfate were omitted in this table due to the detection limit of LC-QTOF/MS technique, when low concentration of untargeted metabolite was used for anal... | PMC9924185 | ||
Compound 1 (M1, t | The MS data detected a deprotonated ion [M–H] | PMC9924185 | ||
Compound 2 (M2, t | The extracted-ion chromatogram (EIC) at 507.2188 (calculated m/z 507.2236) in negative ESI of a deprotonated molecule [M-H] | PMC9924185 | ||
Compound 3 (M3, t | The MS chromatogram of M3 demonstrated the presence of the molecular structure of glucuronide. The deprotonated ion [M–H] | PMC9924185 | ||
Compound 4 (M4, t | Compound 4 (M4) at retention time 10.15 min, showed a deprotonated molecule [M–H] | PMC9924185 | ||
Selection of analytes for further quantitative determination | The WHO monograph on selected medicinal plants indicated the major compounds of | PMC9924185 | ||
Chromatographic and mass spectrometry conditions of LC-QqQ-MS/MS | PMC9924185 | |||
LC optimization | SEPARATION | Chromatographic conditions were optimized to obtain a maximum intensity, and a high sensitivity with well-quantified chromatograms of each candidate analyte (AP1, AP3, AP4 and AP6). Addition of formic acid resulted in peak distortion and a decrease in negative signal intensity of the AP1 parent compound, as described b... | PMC9924185 | |
Mass spectrometric conditions | HEAT | The MS system, coupled with a (-)ESI ion source, was used in this analytical method due to the significant intensity observed in the negative ionization. The MS quantification was obtained by monitoring precursor/product ion transitions (m/z) at 349.1/287.2, 331.1/239.2, 479.2/161.0, 333.1/285.2 and 779.3/649.2 for AP1... | PMC9924185 | |
Method validation results | The new validated method in this study has the ability to fully determine the four major diterpenoids in both plasma and urine, using a small volume of sample (50 µL) and only requiring a short analysis time (6 min) with the lower limit of quantification < 1.00 ng/mL. | PMC9924185 | ||
Selectivity and specificity | There was no interference effect from the endogenous matrix at the retention time of all analytes and IS. The representative chromatograms of blank plasma and urine; and the chromatograms with the retention times of the spiked four diterpenoid standards or IS in methanol, blank plasma and blank urine, are shown in Figs... | PMC9924185 | ||
Accuracy and precision | SD | The %CV for intra-day and inter-day precision of each analyte in plasma sample (Table The intra-day and inter-day accuracy and precision of four major diterpenoids: andrographolide (AP1); 14-deoxy-11, 12-didehydroandrographolide (AP3); neoandrographolide (AP4); and 14-deoxyandrographolide (AP6) in plasma (a) and in uri... | PMC9924185 | |
Linearity, range and lower limit of quantification (LLOQ) | Three calibration curves were calculated based on data from three consecutive days using twelve concentrations for each standard in plasma and urine. The coefficients of variation of AP1, AP3, AP4, and AP6, were 0.24–9.76, 0.58–11.48, 0.20–10.64, 0.53–10.26 for plasma, and 2.71–13.43, 2.57–10.46, 2.55–10.13, 1.69–10.88... | PMC9924185 | ||
Recovery | SD | Mean extraction recovery for each analyte and IS in plasma and urine is summarized in Table Mean extraction recovery, matrix effect, and hemolyzed plasma effect for andrographolide (AP1); 14-deoxy-11, 12-didehydroandrographolide (AP3); neoandrographolide (AP4); and 14-deoxyandrographolide (AP6) in plasma (a) and in uri... | PMC9924185 | |
Matrix effects | The matrix effects at three levels of QC concentrations are presented in Table | PMC9924185 | ||
Stability | The stability of the four major diterpenoids in biological matrices was evaluated under different conditions. The results showed that AP1, AP3, AP4 and AP6 were stable in plasma and urine during five cycles of freeze–thaw storage. The analytes were also found to be stable after 3 months of “long-term” storage at − 80 °... | PMC9924185 | ||
Hemolyzed plasma effects | There was no interference observed in the hemolyzed plasma blank at the retention time of each analyte and of IS. As indicated in Table | PMC9924185 | ||
Conclusion | This newly developed LC–MS/MS method provides a thorough analytical method for the intended purposes of quantitative determination of the four major parent compounds (andrographolide; 14-deoxy-11, 12-didehydroandrographolide; neoandrographolide; and 14-deoxyandrographolide) in both plasma and urine samples. In this way... | PMC9924185 | ||
Supplementary Information |
Supplementary Information. | PMC9924185 | ||
Supplementary Information | The online version contains supplementary material available at 10.1038/s41598-023-28612-1. | PMC9924185 | ||
Acknowledgements | This study was supported in part by a grant from Thailand Science Research and Innovation (TSRI), Chulabhorn Research Institute (grant number: 36822/4274380) and a grant from Thai Traditional Medicinal Knowledge Fund, the Department of Thai Traditional and Alternative Medicine, Ministry of Public Health, Thailand. The ... | PMC9924185 | ||
Author contributions | Conceptualization and Methodology, P.S., N.P., T.S., N.R., D.P., P.P. and J.S.; Subject management and Clinical investigation, P.P.; Method validation, P.S.; Data interpretation and Statistical analysis, P.S.; Writing original draft manuscript, P.S.; Review, N.P., T.S., N.R., D.P., P.P. and J.S.; Supervision, J.S.; Fun... | PMC9924185 | ||
Competing interests | The authors declare no competing interests. | PMC9924185 | ||
References | PMC9924185 | |||
1. Introduction | intellectual impairments, neurodevelopmental disorders, intellectual disabilities, autism | DISORDERS | The purpose of this study was to examine how 14 parents of children with autism and intellectual impairments responded to an Acceptance and Commitment Therapy (ACT)-based psychological flexibility intervention programme. A randomised clinical trial was conducted. Parents were randomly assigned to the training programme... | PMC10002330 |
2. Materials and Methods | PMC10002330 | |||
2.1. Design | This study was approved by the European University of Madrid Ethics Committee (CIPI/20/153). The trial was registered on ClinicalTrials.gov (ID: NCT05611554). Randomisation was completed by the Principal Investigator using an online service and randomly sized, permeated blocks to each arm (ratio: 1:1). The trial was a ... | PMC10002330 | ||
2.2. Participants | neurodevelopmental disorder, neurodevelopmental disorders, intellectual disability | Convenience sampling was carried out based on the availability of participants. The eligibility requirements included being over 18 years old, not currently receiving psychological treatment, being fluent in Spanish, and having a child diagnosed with a neurodevelopmental disorder or intellectual disability. The partici... | PMC10002330 | |
2.4. Procedure | The brief group intervention protocol for family members (9 h) followed a similar structure to the programme implemented in the previous study [ | PMC10002330 | ||
2.5. Statistical Analysis | Pre-treatment, post-treatment, and follow-up (3 months) variables were analysed and described. To evaluate the effectiveness of the intervention protocol, two complementary strategies were used. On the one hand, the scores of the participants on each instrument before the intervention programme were compared to those o... | PMC10002330 | ||
4. Discussion | neurodevelopmental impairments, fatigue, neurodevelopmental disabilities, neurodevelopmental disorders, disability, intellectual disabilities, autism | EVENTS | The ACT-based intervention for parents of children with neurodevelopmental disorders and intellectual disabilities was followed by a significant reduction in perceived stress, thought suppression, and PI. Additionally, changes in the suppression of private events and PF variables were statistically significant at post-... | PMC10002330 |
Author Contributions | Conceptualisation, D.L. and F.M.; methodology, D.L., F.M. and E.P.; software, D.L. and F.M; validation, D.L. and F.M.; formal analysis, D.L., F.M. and E.P.; investigation, D.L. and F.M.; resources, D.L., F.M. and E.P.; data curation, D.L. and F.M.; writing—original draft preparation, D.L. and F.M.; writing—review and e... | PMC10002330 | ||
Institutional Review Board Statement | The study was conducted in accordance with the Declaration of Helsinki and approved by the Ethics Committee of European University of Madrid (protocol code CIPI/20/153 and date of approval 29 July 2020). | PMC10002330 | ||
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC10002330 | ||
Data Availability Statement | Not applicable. | PMC10002330 | ||
Conflicts of Interest | The authors declare no conflict of interest. | PMC10002330 | ||
Abstract | These authors contributed equally to this work and share first authorship. | PMC10321207 | ||
Purpose | breast cancer | BONE METASTASIS, BREAST CANCER | Due to the poor and unpredictable prognosis of breast cancer (BC) patients with bone metastasis, it is necessary to find convenient and available prognostic predictors. This study aimed to recognize the clinical and prognostic factors related to clinical laboratory examination and to construct a prognostic nomogram for... | PMC10321207 |
Methods | REGRESSION, BONE METASTASIS | We retrospectively analyzed 32 candidate indicators from clinical features and laboratory examination data of 276 BC patients with bone metastasis. Univariate and multivariate regression analyses were performed to identify significant prognostic factors related to BC with bone metastasis. Nomogram was constructed and e... | PMC10321207 | |
Results | Patients were randomly grouped into training ( | PMC10321207 | ||
Conclusion | BONE METASTASIS | This study constructed a novel prognostic nomogram for BC patients with bone metastasis. It could serve as a potential tool of survival assessment to help individual treatment decision-making for clinicians. | PMC10321207 | |
KEY MESSAGES | breast cancer | BONE METASTASIS, BREAST CANCER |
Our study investigated potential prognostic value of indicators from biochemical and blood routine examination for breast cancer patients with bone metastasis.Our study established a nomogram based on the indicators from biochemical and blood routine examination, which might enhance the ability to predict prognosis of... | PMC10321207 |
Keywords | PMC10321207 | |||
Introduction | cancers, tumor, malignancy, Breast cancer, cancer death | BREAST CANCER, BONE METASTASIS, CANCERS, TUMOR | Breast cancer (BC), the most frequently diagnosed malignancy, is one of the main causes of cancer death in women [Currently, the prognostic predictors of bone metastasis include the features of original tumor, tumor markers, expression of selected genes, and related clinical manifestations [Increasing studies demonstra... | PMC10321207 |
Materials and methods | PMC10321207 | |||
Research design and patient population | death, primary breast cancer, Cancer | BRAIN METASTASIS, PRIMARY TUMORS, LUNG METASTASIS, BLOOD, BONE METASTASIS, PRIMARY TUMOR, LIVER METASTASIS, CANCER | This was a retrospective study based on patients’ records. From 2010 to 2022, 679 BC patients with bone metastasis were treated in the Cancer Hospital of Shantou University Medical College. We applied strict inclusion and exclusion criteria during the enrollment process. Patients met the following inclusion criteria: (... | PMC10321207 |
Variable selection and nomogram construction | REGRESSION, BONE METASTASES | We randomly partitioned the dataset into training and validation cohorts using R programming language. According to clinical significance, we screened a total of 33 prognostic-related variables in the first step, which consisted of 10 categorical variables and 23 continuous variables. The optimal cut-off values for the... | PMC10321207 | |
Nomogram evaluation | To evaluate the discriminative ability, we constructed a receiver operating characteristic (ROC) curve. The nomogram discrimination efficacy was assessed by concordance index (C-index) and the area under the ROC curve (AUC). They basically ranged from 0.5 (random prediction) to 1.0 (excellent prediction). In general, a... | PMC10321207 | ||
Statistical analysis | In this study, all analyses, figures and tables were performed by IBM SPSS Statistics 26 (La Jolla, CA, USA), Microsoft Excel (Redmond, WA, USA), X-tile version 3.6.1 (Version 3.6.1, Yale University) and R version 4.1.3 ( | PMC10321207 | ||
Results | PMC10321207 | |||
Baseline characteristics | After patients’ enrollment, we analyzed the demographic and clinical characteristic of 276 enrolled patients (Patient characteristics in the study.IQR: interquartile range | PMC10321207 | ||
Cox proportional hazards regression analysis | breast cancer | REGRESSION, METASTASIS, BONE METASTASES, BREAST CANCER | In the training cohort, after univariate Cox regression analysis, 20 variables were significantly associated with OS, including age, ER status, other organ metastasis, and some laboratory test factors consisting of LDH, ALP, GGT, ALB, GLB, BUN, CREAT, UA, WBC, RBC, HGB, MCV, MCH, MCHC, LY%, MO%, and NE%. We drafted Kap... | PMC10321207 |
Construction of 1-, 3-, and 5-year OS predicting nomogram | breast cancer | BONE METASTASIS, BREAST CANCER | Based on the prognostic factors selected in the training cohort, a nomogram was developed for the prediction of OS (Nomogram for 1, 3, and 5-year OS prediction of the breast cancer patients with bone metastasis. Each prognostic factor was assigned a point on the scale, and the sum of the total points projected on the b... | PMC10321207 |
Evaluation of the OS predicting nomogram | ALL, breast cancer | BONE METASTASIS, BREAST CANCER | As shown in Receiver operating characteristic (ROC) curves of 1, 3, and 5-year in the training (A) and validation cohorts (B), respectively. The area under the ROC curve (AUC) was 0.797, 0.782, and 0.794 in the training cohort, and 0.723, 0.742, and 0.704 in the validation cohort, respectively.In both training and vali... | PMC10321207 |
Discussion | esophageal cancer, malignancies, cancer | METASTASIS, OESOPHAGEAL CANCER, INFLAMMATION, CANCER, BONE METASTASIS, MALIGNANT TUMORS, MALIGNANCIES, NASOPHARYNGEAL CARCINOMA, INFLAMMATION, REGRESSION, METASTASES | Although great progress has been made in the diagnosis and treatment of BC, the occurrence of bone metastasis still brings great challenges to the clinicians. Advanced BC is regarded as incurable with current therapeutic strategy [Among our study, the prognosis of patients with additional organ metastatic sites was usu... | PMC10321207 |
Author contributions | Conceptualization, Bo Huang, Fang-Cai Wu, Xin-Jia Wang and Yi-Wei Xu; Data curation, Bo Huang and Fang-Cai Wu; Formal analysis, Bo Huang and Fang-Cai Wu; Funding acquisition, Xin-Jia Wang and Yi-Wei Xu; Investigation, Wei-Dong Wang, Can-Tong Liu, Xiao-Mei Wang, Bu-Qing Shao, Ying-Miao Lin, Guo-Xing Zheng and Ming-Ming ... | PMC10321207 | ||
Disclosure statement | No potential conflict of interest was reported by the author(s). | PMC10321207 | ||
Institutional review board statement | Cancer | CANCER | This research was conducted in the Cancer Hospital of Shantou University Medical College, and this study followed the 2008 Declaration of Helsinki’s ethical guidelines and our hospital code of ethics (2022094). | PMC10321207 |
Data availability statement | The raw data and the R codes supporting the conclusions of this article will be made available by the corresponding authors, without undue reservation. | PMC10321207 | ||
References | PMC10321207 | |||
Abstract | PMC9977742 | |||
Objective | epilepsy | EPILEPSY | The objective of this study is to evaluate the safety and tolerability of intravenous (IV) lacosamide infusion in patients aged ≥1 month to <17 years with epilepsy. | PMC9977742 |
Methods | ADVERSE EVENTS | This Phase 2/3 open‐label trial (EP0060; NCT02710890) enrolled patients in two age cohorts (cohort 1: ≥8 to <17 years; cohort 2: ≥1 month to <8 years). Eligible patients were receiving oral lacosamide as adjunctive treatment or monotherapy (in an open‐label long‐term trial or by prescription) or were not receiving laco... | PMC9977742 | |
Results | TEAEs, seizures | GENERALIZED SEIZURES, FOCAL SEIZURES | In total, 103 patients were enrolled and completed the trial; 55 patients were included in cohort 1 (≥8 to <17 years), 48 in cohort 2 (≥1 month to <8 years). During the 4 weeks before screening, 74 (71.8%) patients had focal seizures, 12 (11.7%) had generalized seizures, and two (1.9%) had unclassified seizures. Most p... | PMC9977742 |
Significance | epilepsy | EPILEPSY | IV lacosamide was generally well tolerated in pediatric patients (≥1 month to <17 years) with epilepsy, and no new safety concerns were identified.
| PMC9977742 |
Key Points | epilepsy | EPILEPSY |
Safety and tolerability of IV lacosamide infusions were evaluated in 103 pediatric patients (≥1 month to <17 years of age) with epilepsy.Seventy‐nine (76.7%) patients had one IV lacosamide infusion, 20 (19.4%) had two, one (1.0%) had three, and three (2.9%) had 10 infusions.The only TEAEs reported in ≥2 patients were ... | PMC9977742 |
INTRODUCTION | epilepsy | FOCAL SEIZURES, EPILEPSY | Lacosamide is an antiseizure medication (ASM). It is a functionalised amino acid that selectively enhances slow inactivation of neuronal voltage‐gated sodium channels.Several trials have investigated the efficacy and safety of oral formulations of lacosamide in pediatric patients. The efficacy and tolerability of adjun... | PMC9977742 |
METHODS | EP0060 was a Phase 2/3, multicentre, open‐label trial. The trial was conducted in accordance with the International Council for Harmonization Good Clinical Practice requirements, the ethical tenets that have their origin in the principles of the Declaration of Helsinki, and the local laws of the countries involved. Wri... | PMC9977742 | ||
Patient eligibility | epilepsy | APPENDIX, FOCAL SEIZURES, CLONIC SEIZURES, EPILEPSY | Patients could be enrolled if they were ≥1 month to <17 years of age, had a diagnosis of epilepsy with focal seizures or primary generalized tonic–clonic seizures, weighed ≥4 kg, and were considered an acceptable candidate for venipuncture and IV infusion. In addition, eligible patients were (i) receiving oral lacosami... | PMC9977742 |
Lacosamide dosing | epilepsy | EPILEPSY | The trial consisted of a screening and/or baseline period of up to 7 days; a treatment period; a final visit (1 day); and a safety follow‐up via telephone over a period of 1‐3 days. Patients received IV lacosamide based on clinical need or elective administration. Clinical need administration applied to patients who ne... | PMC9977742 |
Outcomes | ADVERSE EVENTS | The primary outcomes were treatment‐emergent adverse events (TEAEs), reported spontaneously by the patient and/or caregiver or observed by the investigator, and discontinuations due to TEAEs. Other safety outcomes included changes in 12‐lead electrocardiograms (ECGs), vital sign measurements (blood pressure and pulse r... | PMC9977742 | |
RESULTS | PMC9977742 | |||
Patient disposition and baseline characteristics | antiseizure, seizure, Epilepsy, epilepsy | MAY, EPILEPSY, EPILEPSY | This open‐label trial was conducted between May 2017 and June 2019; 103 patients were enrolled and completed the trial (SS; 77 from Europe, 26 from North America). Most patients (96 [93.2%]) were White. Fifty‐five patients were ≥8 to <17 years of age (cohort 1) and 48 were ≥1 month to <8 years of age (cohort 2). Patien... | PMC9977742 |
Lacosamide exposure | Most patients (74 [71.8%]) initiated lacosamide as adjunctive IV treatment upon enrolment, 26 (25.2%) received IV lacosamide as a replacement for prescribed oral lacosamide from a commercial supply, and three (2.9%) patients received IV lacosamide as a replacement for oral lacosamide received in another open‐label, lon... | PMC9977742 | ||
Safety and tolerability of | ADVERSE EVENTS, EVENT, ADVERSE EVENT, APPENDIX | A total of seven TEAEs were reported in five (4.9%) patients following treatment with IV lacosamide (Table Treatment‐emergent adverse events (SS‐IV)Abbreviations: IV, intravenous; SS‐IV, intravenous Safety Set; TEAE, treatment‐emergent adverse event.Medical Dictionary for Regulatory Activities Version 16.1 Preferred Te... | PMC9977742 | |
DISCUSSION | critically ill, epilepsy | CRITICALLY ILL, EPILEPSY | This open‐label, multicentre trial is the largest prospective investigation of the safety and tolerability of IV lacosamide in pediatric patients with epilepsy. IV lacosamide (2–12 mg/kg/day or 100‐600 mg/day) was generally well tolerated in patients ≥1 month to <17 years of age, and no new safety concerns were identif... | PMC9977742 |
Limitations | epilepsy | FOCAL SEIZURES, CLONIC SEIZURES, EPILEPSY | This trial is limited by its open‐label, uncontrolled design with no comparator or placebo group. The patient population was mostly White; the results may not be generalizable across racial groups. However, no relevant differences in the pharmacokinetics of lacosamide have been observed between healthy Asian, Black, an... | PMC9977742 |
AUTHOR CONTRIBUTIONS | Mark Kristof Farkas and Iryna Makedonska were involved in execution of the trial as study investigators. Cynthia Beller was involved in analysis and interpretation of the data. Ali Bozorg and Nancy Yuen were involved in study design, and analysis and interpretation of the data. Carrie McClung and Robert Roebling were i... | PMC9977742 | ||
CONFLICTS OF INTEREST | Mark Kristof Farkas and Iryna Makedonska each report no conflicts of interest. Cynthia Beller, Ali Bozorg, Carrie McClung, Robert Roebling, Tanisia Yates, and Nancy Yuen are employees of UCB Pharma. | PMC9977742 | ||
ETHICAL APPROVAL | We confirm that we have read the Journal's position on issues involved in ethical publication and affirm that this report is consistent with those guidelines. | PMC9977742 | ||
Supporting information | APPENDIX |
Appendix S1–S2
Click here for additional data file. | PMC9977742 | |
ACKNOWLEDGMENTS | APPENDIX | The authors thank the patients, their caregivers, and the investigators and their teams who contributed to this trial (Appendix | PMC9977742 | |
DATA AVAILABILITY STATEMENT | Underlying data from this manuscript may be requested by qualified researchers 6 months after product approval in the United States and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymised individual patient‐level data and redacted trial ... | PMC9977742 | ||
REFERENCES | PMC9977742 | |||
Methods | HOA | GROUP B | Fifty-seven patients with a lipid layer thickness (LLT) ≤ 75 interferometric colour units (ICU) were included in the study. In group A (20 patients) the effect of a single drop of F6H8 or CN on HOA and LLT was assessed immediately after application and up to two hours later. For long term effects (Group B) 37 patients ... | PMC9847907 |
Results | HOA | CN led to an increase of the LLT from 46.8 ± 16.9 ICU to 76.3 ± 23.5 ICU (p = 0.021) and to an increase of HOA from 0.43 ± 0.06 μm to 0.48 ± 0.08 μm immediately after application (p = 0.027). There was no correlation between the increase of LLT and HOA (r = -0.04; p = 0.90). In group B an increase of LLT was observed i... | PMC9847907 | |
Conclusion | HOA | CN leads to a short-term increase in LLT and HOA, but only immediately after application. In contrast F6H8 does lead to an increase of LLT after regular long-term use but has no effect on HOA. The regular application of lipid-based products does not seem to decrease the quality of vision as measured in HOA. Instead, CN... | PMC9847907 | |
Data Availability | All relevant data are within the paper. | PMC9847907 | ||
Introduction | neurosensory abnormalities, inflammation, Dry Eye Disease, disease of the ocular surface, hyperosmolarity | INFLAMMATION, DRY EYE DISEASE | Dry Eye Disease (DED) is defined as a multifactorial disease of the ocular surface characterized by a loss of homeostasis of the tear film, accompanied by ocular symptoms, in which tear film instability and hyperosmolarity, ocular surface inflammation and damage as well as neurosensory abnormalities play etiological ro... | PMC9847907 |
Materials and methods | PMC9847907 | |||
Trial design | This was a parallel-group, randomized, active-controlled trial. | PMC9847907 | ||
Participants, eligibility criteria, and settings | Eighty-two patients were included in this study. Two separate cohorts were recruited, one (A) to evaluate the immediate effect of a single application of two different lipid-based lubricants and a second (B) to assess the effect of a 12-week treatment with regular application five times per day.In cohort A (short term ... | PMC9847907 | ||
Interventions | Participants in both cohorts were randomized to either receive a cationic nanoemulsion (CN, Cationorm | PMC9847907 | ||
Outcome measurements | DISEASE | All measurements followed the same protocol: First, symptoms were assessed using the Ocular Surface Disease Index (OSDIHOA were calculated from wavefront data based on the ray tracing method and corneal front surface data obtained with a rotating Scheimpflug camera (PentacamNon-invasive measurements of the lipid layer ... | PMC9847907 | |
Sample size consideration | Sample size calculation is obtained from previous studies. | PMC9847907 | ||
Randomization | Using a simple unrestricted system using the random generator function of Excel (Microsoft Excel 2017, Microsofta—CONSORT Flow Diagram for short-term effect group. b—CONSORT Flow Diagram for long-term effect group. | PMC9847907 | ||
Ethics approval | RECRUITMENT, EYE | This prospective interventional randomized study included patients who were referred to Dry Eye clinic of the Department of Ophthalmology, University Hospital Duesseldorf, Germany, and healthy individuals without a history of DED who served as controls. All participants gave written informed consent for pseudonymized d... | PMC9847907 |
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