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Study Procedures
Eligible patients were randomly assigned in a 1:1 ratio to 2 treatment arms: a 3-week regimen (125 mg/m
PMC10712902
Endpoints and Assessment
death, SD, Cancer
DISEASE PROGRESSION, ADVERSE EVENT, DISEASE, SECONDARY, CANCER
The primary endpoint was progression-free survival (PFS), the time from randomization to disease progression or death from any cause, whichever occurred first. The secondary endpoints included the objective response rate (ORR, defined as the proportion of patients with the best overall response of the complete response...
PMC10712902
Statistical Analysis
tumor
DISEASE PROGRESSION, TUMOR PROGRESSION, TUMOR
The trial was powered to assess PFS between the 2 different dose schedules of Efficacy analyses were performed in the full analysis set (FAS) population who had received at least one dose of the study drug. For the primary analysis of PFS, data for patients who were alive and did not have disease progression, lost to f...
PMC10712902
Outcome Notes
ADVERSE EVENTS
See Baseline demographic and clinical characteristics.Data are median (range) or Abbreviation: DFS: disease-free survival.Treatment exposure and dose modifications.Data are mean (SD) or Summary of adverse events.Efficacy outcomes of progression-free survival (PFS) in the FAS population. (Efficacy outcomes of progress...
PMC10712902
Funding
This study was sponsored by CSPC Ouyi Pharmaceutical Co., Ltd.
PMC10712902
Conflict of Interest
The authors indicated no financial relationships.
PMC10712902
Data Availability
The data underlying this article will be shared on reasonable request to the corresponding author.
PMC10712902
IRB Approval
Cancer
CANCER
Ethics committee of Peking University Cancer Hospital & Institute (Approval No. 2018YJZ52).
PMC10712902
References
PMC10712902
Material and Methods
PMC10620860
Ethical Statement
This prospective, randomized observational study was conducted at the Pusan National University Hospital. The study was approved by the Institutional Review Board of the Pusan National University Hospital (IRB number: D-1910-027-083, Busan, South Korea) and was registered with the Clinical Research Information Service ...
PMC10620860
Patients
knee arthroplasty, cognitive impairment, TKA, psychiatric disorders
CRANIAL NERVE DISORDERS
Patients with American Society of Anesthesiologists (ASA) physical status I or II aged ≥65 years who were scheduled for elective total knee arthroplasty (TKA) under spinal anesthesia were eligible. The exclusion criteria were as follows: contraindications to spinal anesthesia; refusal of sedation during surgery; previo...
PMC10620860
Grouping
anxiety
The primary endpoint of this study was to determine different anxiety levels and identify the corresponding frequency bands. The purpose of dividing the patients into three groups was not for inter-group comparisons but rather to vary the levels of anxiety. Therefore, 60 patients were randomly assigned to one of the th...
PMC10620860
Spinal anesthesia and management
hypotension
QUINCKE, COLD, DECUBITUS
All patients received routine preoperative care without premedication. On arrival in the operating room, standard monitoring was initiated, including noninvasive automated blood pressure, electrocardiography, and pulse oximetry. Spinal anesthesia was induced in the lateral decubitus position using a 25-gauge Quincke sp...
PMC10620860
Measurement of anxiety and sedation
anxiety
The state and trait anxiety inventory (STAI) scores were used to assess anxiety during this study
PMC10620860
Functional near-infrared spectroscopy (fNIRS) measurement using NIRSIT ON
NIRSIT
Functional NIRS (fNIRS) was measured continuously for 10 min in each session using NIRSIT ON (OBELAB Inc., Seoul, Republic of Korea) that can measure cerebral oxygen saturation (rSOThe NIRSIT ON sensor is independently composed of two patches (Figure The power of each bandwidth (BW) was calculated within frequencies be...
PMC10620860
Outcome variables
All variables were measured repeatedly over three sessions (session 1: pre-anesthetic period, session 2: immediately after the spinal anesthesia period, and session 3: normal saline or dexmedetomidine administration period) for 10 min each. At each session, vital signs (mean blood pressure (MBP), heart rate (HR), and o...
PMC10620860
Statistical analysis
Statistical analyses were performed using SPSS version 24 (IBM Corp., Armonk, NY, USA), R
PMC10620860
Results
anxiety
A total of 67 patients scheduled for TKA were assessed for eligibility, and seven were excluded (five due to spinal block failure and two for refusal of sedation). The remaining 60 patients were assigned to one of the three groups and completed the study (Figure Table Patient characteristics and the variables assessed ...
PMC10620860
REFERENCES
PMC10247238
Background
clear cell renal cell carcinoma, renal cancer
CLEAR CELL RENAL CELL CARCINOMA, RENAL CANCER
Small (< 4 cm) clear cell renal cell carcinoma (ccRCC) is the most common type of small renal cancer and its prognosis is poor. However, conventional radiological characteristics obtained by computed tomography (CT) are not sufficient to predict the nuclear grade of small ccRCC before surgery.
PMC10561466
Methods
REGRESSION
A total of 113 patients with histologically confirmed ccRCC were randomly assigned to the training set (n = 67) and the testing set (n = 46). The baseline and CT imaging data of the patients were evaluated statistically to develop a clinical model. A radiomics model was created, and the radiomics score (Rad-score) was ...
PMC10561466
Results
REV
The radiomics model was constructed using six features obtained from the CT images. The shape and relative enhancement value of the nephrographic phase (REV of the NP) were found to be independent risk factors in the clinical model. The area under the curve (AUC) values for the training and testing sets for the clinica...
PMC10561466
Conclusion
The CT-based radiomics nomogram has the potential to be a noninvasive and preoperative method for predicting the WHO/ISUP grade of small ccRCC.
PMC10561466
Supplementary Information
The online version contains supplementary material available at 10.1186/s12885-023-11454-5.
PMC10561466
Keywords
PMC10561466
Introduction
RCCs, renal cell carcinoma, aggressiveness, RCC
RENAL CELL CARCINOMA, BENIGN TUMORS, RCC
The increasing use of cross-sectional imaging in recent decades has led to an increase in the incidence of renal cell carcinoma (RCC) [Most small RCCs appear as benign tumors, but some can exhibit high aggressiveness and have the potential to spread to the perirenal fat or distant locations [The most popular noninvasiv...
PMC10561466
Patients and methods
PMC10561466
Patients
high-grade small ccRCC, a renal tumor, Tumors, kidney tumors, tumors
TUMORS, RECRUITMENT, TUMORS, KIDNEY TUMORS
The Institutional Ethics Committee approved this retrospective study and waived the need for patient consent. The study included patients who underwent abdominal CT scans and were diagnosed with a renal tumor at our institution between January 2016 and January 2022. The inclusion criteria were as follows: (1) Patients ...
PMC10561466
CT imaging acquisition
Routine clinical CT scans of the kidney are typically performed using 64-slice multidetector CT equipment. The CT scan parameters are as follows: the tube voltage is 120 kV-140 kV; tube current is 250mA-400 mA; slice thickness is 5 mm. Approximately 80 to 100 mL (1.5mL/kg) of contrast agents (Omnipaque, GE Healthcare) ...
PMC10561466
Traditional radiological characteristics analysis
tumor, calcification, necrosis
CORTEX, TUMOR, LYMPH NODE METASTASIS, NECROSIS
Two radiologists, Reader 1 and Reader 2, with 5 and 10 years of experience in diagnostic abdominal radiology, respectively, conducted a thorough review of the CT images. In cases where there was a disagreement between the two radiologists, they would engage in joint discussions to reach a consensus. The evaluation of t...
PMC10561466
Construction of the clinical model
The differences between clinic-radiological characteristics of high-grade and low-grade small ccRCC were analyzed using univariate analysis. For categorical variables, the Chi-square test or Fisher exact test was used, while for continuous variables, the
PMC10561466
Tumor segmentation and extraction of radiomics features
tumor
TUMOR, RENAL TUMORS
Figure  Schematic diagram of a radiomics study of renal tumors Manual three-dimensional (3D) of the tumor. a, b and c are the unenhanced phase (UP), the corticomedullary phase (CMP) and the nephrographic phase (NP), respectively. d is 3D volumetric reconstructionThe extraction of features was performed using the Artifi...
PMC10561466
Construction of the radiomics model
REGRESSION
To reduce redundant features and mitigate overfitting in the developed radiomics model, the following steps were undertaken for the features in the training set: (1) Features with an ICC greater than 0.75 were selected, (2) Univariate logistic analysis was conducted to identify the features that exhibited statistical s...
PMC10561466
Construction of radiomics nomogram and evaluation model performance
Clinical variables and Rad-score were combined to create a nomogram. Calibration curves were utilized to evaluate the calibration of the nomogram. The Hosmer-Lemeshow test was applied to assess the nomogram’s goodness of fit. The receiver operator characteristic (ROC) curves were utilized to evaluate the discrimination...
PMC10561466
Correlation between rad-score and immune infiltration
kidney tumor
KIDNEY TUMOR, INFILTRATION
To assess the correlation between Rad-score and immune infiltration, we collected immunohistochemical images from 40 patients with small ccRCC and evaluated a total of 12 immunomarkers. Subsequently, hierarchical clustering analyses were performed for specific immunomarkers. We selected paraffin-embedded kidney tumor t...
PMC10561466
Statistical analysis
Python software (v.3.6.0) and R software (v.3.5.1) were used to perform the statistical analysis. A statistically significant difference between the two was defined as
PMC10561466
Results
PMC10561466
Extraction of features and filtering to create a radiomics model
Of the 4785 radiomics features in the three phases, 2560 had good repeatability (ICC > 0.75), and the dimensionality reduction section was based on these features. A total of 597 features were significantly different by univariate analysis. The six most valuable features were selected from 597 features based on the Gra...
PMC10561466
The development of nomogram and evaluation of model performance
high-grade
REGRESSION
The clinic-radiological characteristics and Rad-score from the training cohort were subjected to a multivariate logistic regression analysis to obtain a radiomics nomogram score (Nomo-score): Nomo-score= -3.4699 + 0.9858 × Rad-score + 2.1449 × Shape + 2.4012 × REV2 (Fig.   A radiomics nomogram distinguishing between hi...
PMC10561466
The correlation between rad-score and the immune microenvironment
We examined the expression pattern and distribution of 12 immune markers in 40 patients with small ccRCC. To investigate the relationship between Rad-score and local immune status, we conducted and correlation analyses (Figure
PMC10561466
Discussion
tumor, high-grade, kidney tumors, RCC, tumors
TUMOR, TUMORS, KIDNEY TUMORS, RCC
With the increased detection rate of small ccRCC, the frequent underestimation of the histological grade of tumors on puncture biopsy, and the widespread use of active surveillance for patients with small RCC in clinical practice, a reliable method is needed to differentiate the histological grade of small ccRCC. This ...
PMC10561466
Conclusion
We have developed and validated a CT-based radiomics nomogram that incorporates a rad-score, shape and REV2 to predict the grading of small ccRCC preoperatively. This nomogram will assist clinicians in making informed diagnostic and treatment decisions.
PMC10561466
Acknowledgements
Not applicable.
PMC10561466
Authors’ contributions
YG conceived and wrote the main manuscript text. XW, XZ, CZ and CL collect and process data. JL polished and revised the manuscript. XWu supervised the algorithm development and analyzed the data. All authors read and approved the final manuscript.
PMC10561466
Funding
This work was supported by 2021 Medical Empowerment- Pilot Elite Research Project Special Fund (NO. XM_HR_YXFN_2021_05_19).
PMC10561466
Data availability
The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
PMC10561466
Declarations
PMC10561466
Ethic approval and consent to participate
The Ethics Committee of The First Affiliated Hospital of Anhui Medical University approved this retrospective study, and the informed consent was waived. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and /or national research committe...
PMC10561466
Consent for publication
Not applicable.
PMC10561466
Competing interests
The authors declare no competing interests.
PMC10561466
References
PMC10561466
Objective
LONG COVID
To characterize clinical picture of Long COVID patients and to identify factors associated with quality of life.
PMC10187923
Methods
REGRESSION, SECONDARY, LONG COVID
A secondary data analysis from a randomized clinical trial (RCT) was carried out with 100 Long COVID patients treated by Primary Health Care and residents in the territory of Aragon (northeast of Spain). The main variable of the study was quality of life, evaluated using the SF-36 Questionnaire, in relation to socio-de...
PMC10187923
Results
affective affectation
LONG COVID
Long COVID patients suffer a decrease in their levels of physical and mental health. On the one hand, the higher number of persistent symptoms (b = -0.900, p = 0.008), worse physical functioning (b = 1.587, p = 0.002) and sleep quality (b = -0.538, p = 0.035) are predictors of worse quality of life, physical subscale. ...
PMC10187923
Conclusion
It is necessary to design rehabilitation programs that consider both the physical and mental health of these patients, thus obtaining an improvement in their quality of life.
PMC10187923
Data Availability
The data sets used and/or analyzed during this study are available on the ZENODO platform. They were registered and published on 02/20/2023 with DOI:
PMC10187923
Introduction
COVID-19 Syndrome, cognitive, functional and social variables, fatigue, musculoskeletal pain
DISEASE, SEQUELAE, LONG COVID
Since the World Health Organization (WHO) declared COVID-19 a highly contagious and harmful pandemic for the human species on March 11, 2020 [Even though most people infected with COVID-19 turn out to be asymptomatic or develop mild-moderate symptoms, it is estimated that around 15% of those affected have progressed to...
PMC10187923
Methodology
PMC10187923
Study design
SECONDARY
This research study is a secondary data analysis [
PMC10187923
Sample size
The sample size was established in the RCT study, as can be seen in its protocol article [
PMC10187923
Recruitment and participants
COVID-19 Syndrome
DISEASE
The study population has been Post COVID-19 Syndrome patients, of legal age (18 years or older) and treated by Primary Health Care. The exclusion criteria put forward for its collection have been: not having a positive diagnostic test for COVID-19 for more than the previous 3 months; have a diagnosis of severe uncontro...
PMC10187923
Variables and instruments
myalgia, Gastrointestinal symptoms, fever, cognitive (memory loss, tiredness, spasms, Depression, chills, sore throat, blurred vision, dyspnea, dry, headaches, Anxiety, infections, back pain, hair loss, partial loss of smell or taste, eye problems, fatigue, chest pain, cough, infection, bruising, Insomnia, confusion, t...
SORE THROAT, INFECTIONS, LONG COVID, INFECTION, SECONDARY, HAIR LOSS, CONJUNCTIVITIS, ORTHOSTATIC HYPOTENSION, OVERACTIVE BLADDER, ERECTILE DYSFUNCTION
This study contemplated multiple variables that allow us to know about the Long COVID patient from a broad perspective. For this, in addition to sociodemographic and clinical variables, a total of 10 scales were selected.Socio-demographic variables: gender (man, woman, other), age, civil status (married or in couple/si...
PMC10187923
Statistical analysis
REGRESSION, MOS
Statistical analyses were carried out using the IBM SPSS Statistics version 22.0.0.0 and Microsoft Excel computer programs. First, the sample distribution was analyzed, obtaining Shapiro–Wilk statistic values that were lower than 0.05 for all of the variables except for the number of symptoms, SF-36 general health and ...
PMC10187923
Ethics considerations
Ethics approval was granted by the Clinical Research Ethics Committee of Aragon (PI21/139 and PI21/454). The procedures carried out for the creation of this work complied with the ethical standards of the previously mentioned committee and with the 1975 Declaration of Helsinki. All of the subjects signed an informed co...
PMC10187923
Results
A total of 100 people participated, of which 80 were women and 20 men. The median age was 47 years (IQR 11 years, range: 29–72).
PMC10187923
Description of sociodemographic and clinical variables of the total sample and comparing by gender.
Delving into the persistent symptoms, as can be observed on
PMC10187923
Description of persistent symptomatology, frequency and intensity.
Tables
PMC10187923
Comparation SF-36 physical health score and SF-36 mental health score, according to the gender, marital status, educational level, and employment status.
TWD: temporary work disability.
PMC10187923
Correlation between SF-36 physical health score and SF-36 mental health score and age, number of persistent symptoms, cognitive and physical functioning, affective state, sleep quality, social support, number of steps walked, and personal construct (self-efficacy, patient´s activation and health literacy).
Depression, Anxiety
REGRESSION
HADS: Hospital Anxiety and Depression Scale, MOS-SS: Medical Outcomes Study Social Support Survey (MOS-SS), IPAQ-SF: International Physical Activity Questionnaire-Short FormRegarding the linear regression model, the results are shown in
PMC10187923
Linear regression models in relation to the SF-36 physical and mental health score.
PMC10187923
Discussion
myalgia, cognitive impairment, fatigue, Memory loss, frustration, infection, tiredness, Confusion
DISEASE, CHRONIC DISEASES, COVID-19 INFECTION, LONG COVID, INFECTION, SECONDARY, REGRESSION
This is an analysis of secondary data from an RCT conducted in Spain with 100 Long COVID patients with a diagnostic test for COVID-19 performed 12 weeks or more ago and regularly attended by primary helth care. In this way, it has been tried to obtain scientific evidence that helps to characterize clinical picture of L...
PMC10187923
Limitations and strengths
DISEASE, SECONDARY, PATHOLOGY, LONG COVID
Our study has some limitations. First, although the secondary data analysis of RCTs are a good starting point to know the baseline situations of some investigations [Regarding the strengths, research on the Long COVID disease is scaled up and, particularly, the impact on the quality of life of those affected. For this ...
PMC10187923
Conclusion
cognitive impairment
REGRESSION, LONG COVID
In conclusion, patients diagnosed with Long COVID suffer a decline in their physical and mental health, which are proportionally and significantly correlated with the number of symptoms they present, cognitive impairment, a low affective-emotional state, related problems with their quality sleep and an acceptable level...
PMC10187923
Supporting information
PMC10187923
Frequency and intensity of persistent symptomatology.
Chronicity
(DOCX)Click here for additional data file.The authors would like to thank the Network for Research on Chronicity, Primary Care, and Health Promotion (RICAPPS, code RD21/0016/0001-Health Institute Carlos III, Spain), the Primary Health Care Research Group of Aragon (GAIAP-B21-20R) of the Department of Science, the Unive...
PMC10187923
References
PMC10187923
1. Introduction
Obesity, weight loss
OBESITY, BLOOD, PATHOLOGY, BLIND
Obesity has reached pandemic proportions and has become a major health concern worldwide. Therefore, it is necessary to find new strategies against this condition and its associated comorbidities. Green coffee polyphenols (GCP) and oat beta-glucans (BGs) have proven their hypolipidaemic and hypoglycaemic effects. This ...
PMC10180771
2. Materials and Methods
PMC10180771
2.1. Subjects and Ethical Considerations
SECONDARY, INSULIN RESISTANCE, RECRUITMENT
For the present trial, the primary outcome established was a reduction in body weight. Changes in blood lipids, insulin resistance and body fat percentages were established as secondary outcomes. Based on this, the inclusion criteria for the recruitment of volunteers were as follows: men and women between 18 and 60 yea...
PMC10180771
2.2. Food Supplements
Detailed information on the composition of the food supplements has been described elsewhere [
PMC10180771
2.3. Study Design
BLIND
The study was a randomised, crossover, three-arm, blind intervention that lasted 8.5 months. After a 2-week run-in, volunteers were randomly allocated to begin consuming GCP, BG or GCP/BG; randomisation was carried out using the MicrosoftAt the beginning and end of each intervention period, volunteers attended the Huma...
PMC10180771
2.4. Analysis of Metabolism Biomarkers
MP, Diabetes
DIABETES
After collecting the blood samples, serum and plasma were obtained by centrifugation at 3000× C-peptide, ghrelin, gastric inhibitory polypeptide (GIP), glucagon-like peptide-1 (GLP-1), leptin, glucagon insulin, plasminogen activator inhibitor (PAI-1), resistin and visfatin concentrations were analysed in plasma using t...
PMC10180771
2.5. Statistical Analysis
The sample size was calculated using the G*Power 3.1.9.7 program, considering body weight as the main variable. Assuming a statistical power of 80%, a level of statistical significance of 5%, a two-tailed hypothesis and a standard deviation of 6.5 and aiming to detect a difference of 2.5 kg, the sample size was calcula...
PMC10180771
3. Results
The participants in the study were 17 men and 12 women with a mean BMI of 30.1 ± 0.6 kg/m
PMC10180771
3.1. Dietary Intake
The data on macro- and micronutrient intake during the study are shown in
PMC10180771
3.5. Hepatic Function and Inflammatory Markers
Finally,
PMC10180771
4. Discussion
cardiometabolic diseases, reduction in blood pressure, TG, weight reduction
CVD, OBESE, INSULIN SENSITIVITY
Changes in dietary habits, such as reducing total energy intake, limiting the consumption of fat- and carbohydrate-rich foods and increasing the consumption of plant-based foods such as vegetables, legumes, fruits and nuts, along with an active lifestyle and regular exercise, are considered the most effective strategie...
PMC10180771
5. Conclusions
overweight
OBESE
The regular intake of the studied food supplements containing BG could improve DBP and VLDL-C blood concentrations, which are of interest in cardiovascular health. However, the consumption of GCP, BG and a combination of both bioactive ingredients was not enough to induce significant positive changes in lipid and gluco...
PMC10180771
Author Contributions
Conceptualisation, L.B., R.M. and B.S.; methodology, J.G.-C., B.S., R.M., J.L.S.-C., M.A.S. and S.G.-R.; software, J.G.-C., J.L.S.-C., B.S., M.A.S. and S.G.-R.; validation, B.S. and L.B.; formal analysis, J.G.-C., M.A.S. and S.G.-R.; investigation, B.S., R.M. and L.B.; resources, L.B. and R.M.; data curation, J.G.-C., ...
PMC10180771
Institutional Review Board Statement
The study was conducted in accordance with the Declaration of Helsinki and approved by the Clinical Research Ethics Committee of Hospital Universitario Puerta de Hierro, Majadahonda in Madrid (Spain), and the Bioethics Subcommittee of Consejo Superior de Investigaciones Científicas (CSIC). The study was registered in C...
PMC10180771
Informed Consent Statement
Informed consent was obtained from all subjects involved in the study.
PMC10180771
Data Availability Statement
Data may be available from the corresponding author upon request.
PMC10180771
Conflicts of Interest
The authors declare no conflict of interest. The funders had no role in the design of the study; in the collection, analyses or interpretation of data; in the writing of the manuscript; or in the decision to publish the results.
PMC10180771
References
BLOOD
Study flow diagram (Consolidated Standards of Reporting Trials, CONSORT 2010).Energy, macronutrient and micronutrient intake recorded in 72 h recalls filled in by volunteers at each intervention stage with the food supplements containing green coffee polyphenols (GCP), beta-glucan (BG) and the mixture of GCP/BG.Data ex...
PMC10180771
Objective
The objective was to analyse and compare the formation and quality of the embryos developed using conventional in vitro fertilization (IVF) and IVC techniques with an INVOCell™ device.
PMC10712802
Methods
Two groups were formed, with eight couples in each, one in culture for three days (D3) and another in culture for five days (D5), using intravaginal culture technique with an INVOcell device and a conventional in vitro fertilization technique.
PMC10712802
Results
Embryo formation in Group D5 showed 46.7% (IVC) and 40% (IVF) of recovered blastocysts. In the group D5, the conventional IVF, better embryo development dynamics was observed, with 66% of expanded blastocysts, against 28% in the IVC. Group D3 showed 75% (IVC) and 53% (IVF) of embryo formation. Embryonic quality in Grou...
PMC10712802
Conclusions
The results showed that the IVC technique, using the INVOCell™ device, provided a healthy and balanced environment for the development and obtaining of quality embryos with three and five days of culture.
PMC10712802
INTRODUCTION
Infertility
INFERTILITY
Infertility is a public health problem that according to the World Health Organization (The intravaginal culture (IVC) technique using the INVOCell ™ device has being offered as a novelty, and has been a topic in clinical discussions, but this technology is not new (In Brazil, This study aimed to analyse the rate and q...
PMC10712802