title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
|---|---|---|---|---|
Relationship between sleep health improvement and individual attributes. | (Notes) 1. Robust standard errors in parentheses.2. ***, **, and * indicate statistical significance at the 1%, 5%, and 10% levels.3. The purpose at the start of the program (multiple responses) and major changes in work and life during the program period are used as control variables but are omitted from the table. | PMC10553342 | ||
5. Discussion and conclusion | major loss, insomnia, sleep deficiency, ’ behavior | EVENTS | Using a randomized controlled trial of a sleep improvement program in a firm’s workforce, this paper examined the extent to which improved sleep health increases work productivity. The results of the analysis revealed the following. First, participants in the sleep improvement program showed a statistically significant... | PMC10553342 |
Supporting information | TRANSFORMATION | (PDF)Click here for additional data file.This paper is a part of a joint research project combining the studies “Research on Work Style Reform and Health Management” (Sachiko Kuroda) and “Productivity Effects of Personnel Policies and the Transformation of Employment Systems” (Hideo Owan) at the Research Institute of E... | PMC10553342 | |
References | PMC10553342 | |||
Subject terms | meniscal injury, meniscus injury | Immunity-and-matrix-regulatory cells (IMRCs) derived from human embryonic stem cells have unique abilities in modulating immunity and regulating the extracellular matrix, which could be mass-produced with stable biological properties. Despite resemblance to mesenchymal stem cells (MSCs) in terms of self-renew and tri-l... | PMC10618459 | |
Introduction | meniscus injuries, meniscus injury, Meniscus injuries, injuries | Meniscus injuries are the second most commonly occurring injuries to the knee.Stem cell-based regenerative therapy is an emerging and promising option for healing meniscus injury.To date, one double-blinded randomized controlled trialIn the present study, we found that hESCs-derived-IMRCs present strong immunomodulator... | PMC10618459 | |
Results | PMC10618459 | |||
IMRCs possess a stronger immunomodulatory and pro-regenerative profile than UCMSCs | PROLIFERATION | In this study, IMRCs derived from hESCs were generated through the passage of migrating cells acquired from human embryoid bodies (hEBs) using serum-free reagents (Supplementary Fig. IMRCs activated by synovial fluid enhanced chondrocytes proliferation and differentiation. In order to obtain a more comprehensive unders... | PMC10618459 | |
IMRCs have a good safety profile for administration in vivo | Toxicity | The IMRCs used in this study were the same batch as before, and the detailed karyotyping and in vivo tumorigenicity assays had been described in our previous article.Toxicity test after cell transplantation. The study design, macroscopic observation, histological analysis and representative immunohistochemical staining... | PMC10618459 | |
Intra-articular injection of IMRCs repairs punch defects in the rabbits’ meniscus | fibrous | The efficacy of this IMRCs-based therapy was further evaluated. At week 8 post-injection, samples of the entire meniscus of rabbits were collected for macroscopic observations and assessed using a semi-quantitative scale according to the previous report.Strongly positive Safranin-O staining (red) of extracellular matri... | PMC10618459 | |
A phase I dose-escalating trial of IMRCs in the treatment of meniscus injury | PMC10618459 | |||
Intra-articular injection of IMRCs is safe | pain | ADVERSE EVENTS, BLOOD, BLOOD CLOTTING | All participants tolerated the injection procedure well, with no serious adverse events (SAE) associated with IMRCs during the post-procedure period. Four of the 18 patients (22.2%) experienced symptoms of mild adverse events (AEs), including joint pain after injection in 1 case of the mid-dose group and local swelling... | PMC10618459 |
Radiological analysis shows that IMRCs enhance meniscus repair | meniscus injury | The efficacy of IMRCs was assessed using MRI according to the Stoller’s classification standard of meniscus injury.Clinical trial shows efficacy outcomes of IMRCs in MRI analysis and knee function scores after IMRCs injection. Data from meniscus MRI images at week 1, 4, 8, 12 and 48 after IMRCs injection demonstrated t... | PMC10618459 | |
Intra-articular injection of IMRCs relieves pain and improves knee function | pain | OSTEOARTHRITIS | The pain intensity was assessed on a 10-point Visual Analogue Score (VAS). In a total of 18 cases, the VAS (described as mean ± SEM below) decreased from 3.50 ± 0.40 before treatment to 1.69 ± 0.33 at week 48 after IMRCs injection, and the VAS pain intensity in patients was significantly decreased compared to the basel... | PMC10618459 |
Discussion | TGF-β1, meniscus injury, avascular | The meniscus has limited healing capacity, especially the avascular zone that occupies two-thirds of the meniscus. We have shown that intra-articular injection of hESCs-derived IMRCs enables the endogenous regeneration of injured meniscus in rabbits. This is likely achieved by modulating the injured environment as the ... | PMC10618459 | |
Materials and methods | PMC10618459 | |||
Cell culture | The IMRCs were prepared as described previously, and they have been verified in accordance with the requirements of China’s National Institutes for Food and Drug Control (NIFDC). | PMC10618459 | ||
Cell co-culture with synovial fluid stimulation | At the fourth passage, cells were digested and plated onto 12-well plates. IMRCs and UCMSCs were seeded at a density of 1 × 10 | PMC10618459 | ||
Cytokine analysis | The supernatants of IMRCs and UCMSCs were collected after synovial fluid stimulation for 24 h. The samples were analyzed by 48-plex Bio-Plex Pro Human Cytokine Assay (Bio-Rad, Hercules, CA, USA; 1200728), following the guidelines provided by the manufacturer. | PMC10618459 | ||
Preparation and analysis of RNA-seq libraries | Total RNA was extracted from IMRCs and UCMSCs using Trizol (Invitrogen, Waltham, MA, USA; 15596018). Subsequently, RNA-seq libraries were prepared with the NEBNext | PMC10618459 | ||
Animals | All animal experiments were conducted according to protocols approved by the Animal Care and Use Committee of Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology (Registration number: TJH-201806001). 26 New Zealand white rabbits that were 6 months old and weighed 2.5-3.0 kg were obt... | PMC10618459 | ||
Animal surgery and post-surgery care | STERILE | All rabbits fasted for 12 h before surgery. In sterile settings, a knee arthrotomy was performed under general anesthesia (RDW Life Science Co., Ltd., isoflurane, R510-22-10). Anesthesia was supplied with a small oxygen mask through a veterinary isoflurane tank (RDW Life Science Co., Ltd., R580). The anesthesia was ind... | PMC10618459 | |
Cell transplantation and immunosuppression in rabbits | To evaluate their safety over both short and long durations, we conducted a series of biosafety experiments following the ‘Guidelines for Human Somatic Cell Therapies and Quality Control of Cell-based Products’ issued by the China Food and Drug Administration (CFDA).The IMRCs stored in a liquid nitrogen tank were thawe... | PMC10618459 | ||
Tissue harvesting and processing in rabbits | dehydration, overdosage | DEHYDRATION | The rabbits were sacrificed by overdosage with isoflurane 8 weeks after IMRCs injection with anesthesia. After sacrificing, the organs and whole meniscus were placed in 4% ice-cold PFA. Images of the whole meniscus were taken on the same day of harvesting and further completed the dehydration, paraffin embedding, and s... | PMC10618459 |
Macroscopic observation and semiquantitative scoring | Tissue growth was assessed macroscopically using naked-eye observation and entire meniscus images were obtained under a microscope (Guangzhou Micro-shot Technology Co., Ltd., MZ62). The meniscus defect filling and quality of repair were assessed. The defect repair and other features of repair were scored with a semiqua... | PMC10618459 | ||
Histological evaluation and immunohistochemistry staining of the regenerated tissue | toxicity | SECONDARY | All the tissues were sliced with microtome at 4 μm thickness. To detect meniscus cells (chondrocytes) in the neo-meniscus and analyze collagen distribution, matrix stainability and matrix contents, glycosaminoglycan, H&E staining, Masson’s trichrome and Safranin-O staining were used. For toxicity analysis, H&E staining... | PMC10618459 |
Fluorescence in situ hybridization (FISH) analysis for existing of IMRCs | Human DNA-specific reference probes linked to fluorescent molecules, i.e., FISH analysis was used to detect human cells in the rabbit meniscus and internal organs according to previous reports. | PMC10618459 | ||
Dose-escalating clinical trial design and ethical considerations | meniscus injury | The study is an open-label, dose-escalation phase I clinical trial conducted from January 2019 to December 2020 that investigated the role of human embryonic stem cells-derived mesenchymal stem cells (IMRCs) in the treatment of meniscus injury (ClinicalTrials.gov Identifier: NCT03839238). The protocol was approved by t... | PMC10618459 | |
Participants Eligibility | 25 patients were screened. Eligible trial subjects were adults (18-65 years old) with Grade I-II meniscus injury according to the Stoller classification standard | PMC10618459 | ||
Allocation and Interventions | Eighteen patients enrolled in our study were sequence assigned to three groups: 6 patients in each of the three-group received 1 | PMC10618459 | ||
Outcome measures | PMC10618459 | |||
Primary outcome | Cancer | ADVERSE EVENTS, ADVERSE EVENT, ADVERSE EVENT, CANCER | Safety was measured by the documentation of local and systemic adverse events. A combination of vital signs, physical examination, and blood test (including the routine manual complete blood count, biochemistry, liver, kidney function, electrolytes, coagulation, cellular immunity, lymphocyte function and cytokines) and... | PMC10618459 |
Statistical analysis | SPSS 23.0 software was used for the statistical analysis. Outcome measures were analyzed based on the intention-to-treat population. Data are reported as means ± SEM. An unpaired t-test was used to assess efficacy before and after injection, and a one-way analysis of variances was used for the comparison in three group... | PMC10618459 | ||
Supplementary information |
Supplementary MaterialsSupplementary Table 2These authors contributed equally: Liangjiang Huang, Song Zhang, Jun Wu, Baojie Guo | PMC10618459 | ||
Supplementary information | The online version contains supplementary material available at 10.1038/s41392-023-01670-7. | PMC10618459 | ||
Acknowledgements | This work was supported by the Natural Key Research and Development Program (No: 2021YFA1101604), the key Research and Development program of Hubei province (2022BCA028), the international cooperation project of China Manned Space Program, and program for Tongji Hospital Academic Frontier Youth Team(2019A20). We thank ... | PMC10618459 | ||
Author contributions | H.C., J.H., and B.Y.H. conceived the project and supervised the experiments. L.J.H., Y.J.L.(Yajie Li), and Y.Y.L. conducted the injection operation and patient care. S.Z., J.W., B.J.G., Z.W.L., and S.Z.A.S. performed the animal safety experiments. T.T.G., W.J.L., and Y.T. participated in stem cell differentiation and e... | PMC10618459 | ||
Data availability | The data used in the current study are available from the corresponding authors upon reasonable request. Participants data without names and identifiers will be made available after approval from all corresponding authors. Please refer to Supplementary Materials and Methods for further details regarding the materials a... | PMC10618459 | ||
Competing interests | The authors declare no competing interests. | PMC10618459 | ||
References | PMC10618459 | |||
Background | NCT03592264 | SOLID TUMORS | Report of a Phase 1 dose-escalation study of OBI-3424 monotherapy in patients with advanced solid tumors (NCT03592264). | PMC10180615 |
Methods | A classic 3 + 3 design was used to determine the maximum tolerated dose and recommended Phase 2 dose (RP2D) of OBI-3424 administered intravenously, as a single agent, at doses of 1, 2, 4, 6, 8, or 12 mg/m | PMC10180615 | ||
Results | toxicities, Dose-limiting | Dose-limiting hematologic toxicities at 12 mg/m | PMC10180615 | |
Conclusions | The RP2D is 12 mg/m | PMC10180615 | ||
Subject terms | PMC10180615 | |||
Introduction | NSCLC, tumor, cancers, cancer, prostate | TUMOR, CANCERS, CANCER, PROSTATE, HEPATOCELLULAR CARCINOMA, NSCLC | Aldo-keto reductases (AKRs) are a superfamily of NAD(P)(H)-dependent oxidoreductases that primarily catalyze the reduction of aldehydes and ketones to their corresponding alcohols [AKR1C3 is expressed in various normal human tissues, including sex hormone-dependent (e.g., testis, breast, endometrium, and prostate) and ... | PMC10180615 |
Reduction of OBI-3424 by AKR1C3 in the presence of NADPH to produce the cytotoxic agent OBI-2660. | NSCLC, human hepatocellular carcinoma, death | SOLID TUMORS, CYTOTOXICITY, NSCLC | In the presence of NADPH, reduction of OBI-3424 is mediated by AKR1C3 to release the cytotoxic moiety OBI-2660, which is an aziridine bis-alkylating agent, leading to crosslinking of DNA at the N7 (or O6) position of guanine and subsequent cell death. AKR1C3 aldo-keto reductase family 1 member C3.In a study using 11 hu... | PMC10180615 |
Methods | Cancer | CANCER | The study was conducted at two centers in the United States: The University of Texas MD Anderson Cancer Center and The Ohio State University Comprehensive Cancer Center. All patients provided written informed consent at the time of enrollment stating that they were aware of the investigational nature of the study. The ... | PMC10180615 |
Patients | cancers, Tumors, active malignancies, infection, hematologic, hepatic, and renal function | CANCERS, BRAIN METASTASES, DISEASE, SOLID TUMORS, TUMORS, INFECTION, NONMELANOMA SKIN CANCER, ONCOLOGY, IN SITU CANCER | Eligible patients were ≥18 years of age and had histologically or cytologically confirmed advanced solid tumors for which standard treatments were exhausted or were no longer effective; measurable disease as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) guidelines; Eastern Cooperative Oncol... | PMC10180615 |
Study design | toxicities, treatment-emergent adverse, DLTs, tumor | TUMOR | A standard “3 + 3” dose-escalation design was used. The primary endpoints were incidence of dose-limiting toxicities (DLTs) and treatment-emergent adverse events (TEAEs), determination of the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D), and characterization of the OBI-3424 pharmacokinetic profile. Seco... | PMC10180615 |
Treatment | OBI-3424 was administered by intravenous infusion over 30 min. The starting dose of OBI-3424, 1 mg/m | PMC10180615 | ||
Patient monitoring | tumor, bleeding, Tumor, neutropenia, fatigue, toxicity, diarrhea, thrombocytopenia, fever, nausea,, Cancer | ADVERSE EVENT, TUMOR, BLEEDING, TUMOR, NEUTROPENIA, FEBRILE NEUTROPENIA, THROMBOCYTOPENIA, EVENTS, CANCER | Safety assessments were performed at least once every 3 weeks throughout the study treatment period and included physical examination, measurement of vital signs, clinical laboratory tests, 12-lead electrocardiography, and urinalysis. Cell counts, concomitant medication review, and collection of TEAEs were done weekly.... | PMC10180615 |
Pharmacokinetics | OBI-3424 (prodrug) and OBI-2660 (active metabolite) concentrations were analyzed from blood samples collected on day 1 of cycle 1 before, 15 min after the beginning of, and at the end of the infusion and 15, 30, 60, and 90 min and 2, 4, 6, and 8 h after the end of the infusion. Human plasma samples were analyzed by a v... | PMC10180615 | ||
Pharmacodynamics and biomarkers | tumor, tumors | TUMOR, TUMORS | Optional tumor tissue samples were collected prior to screening to measure AKR1C3 expression. OBI worked with the in vitro diagnostics company NeoGenomics Laboratories, Inc. (Aliso Viejo, CA, USA) to develop a validated immunohistochemistry (IHC) assay, which is being used to identify patients whose tumors have “high A... | PMC10180615 |
AKR1C3 expression level in 10 tumor tissue types. | tumor, SCC squamous cell carcinoma, Tumor, HCC hepatocellular carcinoma, HNSCC head and neck squamous cell carcinoma, CRC colorectal carcinoma | TUMOR, TUMOR | AKR1C3 aldo-keto reductase family 1 member C3, CRC colorectal carcinoma, HCC hepatocellular carcinoma, HNSCC head and neck squamous cell carcinoma, IHC immunohistochemistry, SCC squamous cell carcinoma. Tissue slides were considered evaluable if hematoxylin and eosin staining showed ≥100 viable tumor cells. AKR1C3 expr... | PMC10180615 |
Statistical analysis | The sample size in the current study was determined empirically, and there was no formal hypothesis testing. Categorical and continuous data were summarized with frequencies and percentages or descriptive statistics, respectively. All patients who received ≥1 dose of OBI-3424 ( | PMC10180615 | ||
Results | PMC10180615 | |||
Dose-limiting toxicity and maximum tolerated dose | In Schedule A, OBI-3424 was well tolerated at doses of up to 8 mg/m | PMC10180615 | ||
Hemoglobin level and platelet count changes with treatment. | Change in ( | PMC10180615 | ||
Pharmacokinetics | Mean plasma concentration versus time profiles of single doses of OBI-3424 and its active metabolite (OBI-2660) at doses ranging from 1 to 14 mg/m | PMC10180615 | ||
Pharmacodynamics | tumor | TUMOR | Thirty-two of the 39 patients provided archival (28/32) or fresh biopsy (4/32) tumor tissue specimens for AKR1C3 expression testing using the validated, automated IHC assay (NeoGenomics). Among the 32 specimens, 6 tumor tissue specimens did not have sufficient viable tumor cells and were non-evaluable. AKR1C3 H-scores ... | PMC10180615 |
Antitumor activity | tumor | DISEASE PROGRESSION, TUMOR, CHOLANGIOCARCINOMA | Thirty-three of 39 patients were evaluable for tumor response by RECIST v1.1. Six patients were not evaluable because of early discontinuation due to disease progression (A patient with cholangiocarcinoma, treated with OBI-3424 at 10 mg/mReasons for discontinuation of the study drug for all patients were as follows: di... | PMC10180615 |
Discussion | nausea, T-cell ALL, tumor, cancers, fatigue, epithelial carcinomas, thrombocytopenia, thrombocyopenia, anemia, B-cell ALL, hepatocellular tumors, ALL, hepatocellular cancer, advanced/metastatic pancreatic cancer, cholangiocarcinoma | TUMOR, CANCERS, PANCREATIC TUMORS, DISEASE, THROMBOCYTOPENIA, B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA, ANEMIA, CHOLANGIOCARCINOMA | In this first-in-human, dose-escalation, Phase 1 study, OBI-3424, a small-molecule prodrug, was tolerated at doses of up to 14 mg/mThe most common TEAEs were anemia (64%), thrombocytopenia (49%), nausea (26%), and fatigue (21%). Three patients experienced serious TEAEs; all 3 experienced grade ≥3 anemia and 2 of the 3 ... | PMC10180615 |
Supplementary information | The online version contains supplementary material available at 10.1038/s41416-023-02280-4. | PMC10180615 | ||
Acknowledgements | We thank the investigators, coordinators, and study site personnel, as well as the patients and their families for participation in this study. We also acknowledge Leslie Chu, PhD, and Donald Young, MS, whose work was funded by OBI Pharma Inc, for assistance in writing this article. | PMC10180615 | ||
Author contributions | All authors contributed to the concept and design of the study; the acquisition, analysis, and interpretation of data; the drafting and revising of the manuscript; and the final approval of the manuscript submission. | PMC10180615 | ||
Funding | This study was funded by OBI Pharma Inc., Taipei City, Taiwan. | PMC10180615 | ||
Data availability | The data generated in the current study are available within the article and its supplementary data files. | PMC10180615 | ||
Competing interests | Diaccurate, Cancer | CANCER | Dr. AMT has received clinical trial research funding (through her institution) from OBI Pharma USA Inc., IMMATICS, Parker Institute for Cancer Immunotherapy, Agenus, Tempus, Tvardi, Boston Biomedical, and Karus Therapeutics. Dr. AMT has served in a consulting or advisory role for Vincerx, Diaccurate, and BrYet. Dr. CFV... | PMC10180615 |
Ethics approval and consent to participate | All patients provided written informed consent at the time of enrollment stating that they were aware of the investigational nature of the study. The study was approved by the institutional review board of both institutions and conducted in accordance with the ethical principles of the International Council for Harmoni... | PMC10180615 | ||
Consent for publication | Not applicable. | PMC10180615 | ||
References | PMC10180615 | |||
Objective | rhinopharyngeal obstruction | To analyze the reliability of estimating the percentage of rhinopharyngeal obstruction by the adenoid using nasofibroscopy and its correlation with clinical symptoms. | PMC10493505 | |
Methods | OSA, rhinopharyngeal obstruction | SLEEP APNEA, OBSTRUCTIVE SLEEP APNEA | Cross-sectional observational study was conducted, involving 80 patients between 4 and 14 years old, recruited from Santa Casa of São Paulo general otorhinolaryngology outpatient service during the years of 2020 and 2021. All patients underwent nasal endoscopy examination, and the recorded videos were randomly assigned... | PMC10493505 |
Results | Satisfactory intra- and inter-rater correlations were observed, and the results were consistent with the Pro Image J Software. However, no correlation was found between the percentage of obstruction and the severity of clinical symptoms. | PMC10493505 | ||
Conclusion | rhinopharyngeal obstruction | Nasofibroscopy demonstrates good reliability in assessing a percentage of rhinopharyngeal obstruction caused by adenoids. However, there is no correlation between the degree of obstruction of the rhinopharynx and the clinical symptoms. | PMC10493505 | |
Level of evidence | 4. | PMC10493505 | ||
Keywords | PMC10493505 | |||
Introduction | rhinopharyngeal obstruction, Adenoid hypertrophy, hypertrophy, nasal obstruction, adenoid hypertrophy | SLEEP APNEA, ADENOID HYPERTROPHY, TONSILLAR HYPERTROPHY, HYPERTROPHY, ADENOID HYPERTROPHY | Adenoid hypertrophy is one of the most common alterations of the upper airways in childhoodNasofibroscopy is considered the gold standard exam for assessing adenoid hypertrophy, enabling direct visualization of the rhinopharynx and adenoid lymphoid tissue.Unlike tonsillar hypertrophy,The limitations of the technique, a... | PMC10493505 |
Methods | upper airway infection, rhinopharyngeal obstruction, nasosinusal complaints, OSA, palate, congenital diseases, craniofacial malformations | OBSTRUCTIVE SLEEP APNEA, DOWN SYNDROME, IMMUNODEFICIENCIES, TONSILLAR HYPERTROPHY, NEUROMUSCULAR DISEASES, CONGENITAL DISEASES | Cross-sectional observational study that analyzes the reliability of adenoid evaluation by nasofibroscopy and correlates the degree of rhinopharyngeal obstruction with clinical symptoms.The study was approved by the Ethics and Research Committee (CAAE 29266820.1.0000.5479). Data were stored on the RedCap platform.The p... | PMC10493505 |
Statistical analysis | obstruction of the rhinopharynx, Obstruction of the rhinopharynx, rhinopharyngeal obstruction | The sample size was calculated based on Pearson's correlation, adopting a significance level of 5%, test power of 80%, and an initial correlation between obstruction of the rhinopharynx by adenoid and clinical symptoms of 0.4 was assumed, resulting in a minimum sample of 50 patients.Intra-rater reliability (between T1 ... | PMC10493505 | |
Results | adenoid hypertrophy, obstruction of the rhinopharynx, inferior turbinate hypertrophy, XXX | ADENOID HYPERTROPHY, ALLERGIC RHINITIS | Eighty patients from the General Otorhinolaryngology outpatient clinic of XXX were screened. Among them, 29 were not included in the analysis (Flowchart representing the selection criteria applied to the study patients.The demographic and clinical characteristics of the included patients are described in Clinical and d... | PMC10493505 |
Discussion | rhinopharyngeal obstruction, rhinorrhea, otitis, adenoid hypertrophy, respiratory complaints, obstruction of the rhinopharynx), obstruction by the adenoid, nasal obstruction, palate, airway infection, adenoid, hypertrophic adenoids, tonsil hypertrophy | HYPERTROPHIC, OTITIS, SLEEP APNEA, ALLERGIC RHINITIS, ADENOID HYPERTROPHY, TONSIL HYPERTROPHY, COMPLICATIONS | Although nasofibroscopy is considered the gold standard exam in the diagnosis of adenoid hypertrophy, most studies use classifications that are not currently used in clinical practice.In the study, all four evaluators demonstrated a good correlation between T1 and T2 times (R > 0.7). However, although it is a good corr... | PMC10493505 |
Conclusion | rhinopharyngeal obstruction | ADENOID HYPERTROPHY | The findings of this study allow us to conclude that the evaluation of the percentage of rhinopharyngeal obstruction by the adenoid, through nasofibroscopy, is a reliable, consistent, and reproducible method for the evaluation and classification of adenoid hypertrophy. However, no correlation was observed between the d... | PMC10493505 |
Conflicts of interest | The authors declare no conflicts of interest. | PMC10493505 | ||
References | PMC10493505 | |||
Supplementary data | The following are Supplementary data to this article:Supplementary material related to this article can be found, in the online version, at doi: | PMC10493505 | ||
Background | critically ill | CRITICALLY ILL | Intention-to-treat analyses of POINCARE-2 trial led to inconclusive results regarding the effect of a conservative fluid balance strategy on mortality in critically ill patients. The present as-treated analysis aimed to assess the effectiveness of actual exposure to POINCARE-2 strategy on 60-day mortality in critically... | PMC10626740 |
Methods | REGRESSION | POINCARE‑2 was a stepped wedge randomized controlled trial. Eligible patients were ≥ 18 years old, under mechanical ventilation and had an expected length of stay in ICU > 24 h. POINCARE-2 strategy consisted of daily weighing over 14 days, and subsequent restriction of fluid intake, administration of diuretics, and/or ... | PMC10626740 | |
Results | A total of 1361 patients were included. Overall, 24.8% of patients in the control group and 69.4% of patients in the strategy group had a score of exposure ≥ 75. Exposure to the POINCARE-2 strategy was not associated with 60-day all-cause mortality (ALR: OR 1.2, 95% CI 0.85–1.55; IVLR: OR 1.0, 95% CI 0.76–1.33). | PMC10626740 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s13054-023-04701-5. | PMC10626740 | ||
Keywords | PMC10626740 | |||
Background | cancers, critically ill, ARDS, septic shock | CANCERS, CRITICALLY ILL, HEMODYNAMIC INSTABILITY, SEPTIC SHOCK, ARDS, ACUTE RESPIRATORY DISTRESS SYNDROME | Among critically ill patients in intensive care units (ICU), early and aggressive fluid resuscitation is indicated to tackle hemodynamic instability [Higher mortality was reported in critically ill patients with a positive fluid balance in various clinical settings, such as septic shock, acute respiratory distress synd... | PMC10626740 |
Methods | PMC10626740 | |||
Design and setting | CRITICALLY ILL | The POids INtensive CARE 2 (POINCARE-2) trial was a stepped wedge cluster randomized controlled trial implemented in 12 French ICUs [Critically ill patients who were admitted to one of the 12 recruiting ICUs were allocated either to the control group (and received standard of care during the control period) or to the s... | PMC10626740 | |
Population and sampling | trauma | Eligible patients were ≥ 18 years old, under mechanical ventilation (through endotracheal intubation), admitted to one of the 12 participating ICUs between 48 and 72 h prior to inclusion, and with an expected length of stay after inclusion of > 24 h.Main exclusion criteria were clinical condition or unavailability of b... | PMC10626740 | |
Assessment of exposure to the strategy | To assess exposure of patients to the strategy under scrutiny, we developed a dedicated score. This score was based on the amount of deviation from the algorithm on which the strategy relied (Additional file Additional file | PMC10626740 | ||
Outcomes | myocardial infarction, patent mesenteric ischemia, RIFLE, hypotension, renal damage, hypokalemia, VFDs | HYPERNATREMIA, EVENT, MYOCARDIAL INFARCTION, EVENTS | The main outcome was vital status at Day 60 (alive vs deceased). Secondary outcomes included mechanical ventilator-free days (MVFDs) and vasopressor-free days (VFDs), defined as the cumulative number of days alive with no mechanical ventilation (or no prescription of vasopressor, respectively) between Day0 and Day28; r... | PMC10626740 |
Statistical analysis | PMC10626740 | |||
Descriptive analyses | EVENTS, SECONDARY | We first described the distribution of the score of exposure to the strategy in our sample, overall and by group. We then described patients’ characteristics at admission, overall, and stratified on (1) the quartile of score of exposure to the strategy, and (2) both the ICU and the group, using mean (standard deviation... | PMC10626740 |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.