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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Participants | Alzheimer’s disease, memory loss, dementia, cognitive impairment | Participants were aged 66 years or older on waiting lists at 3 MOW programs in Florida (1 program) and Texas (2 programs). We included participants who had self-reported or proxy-reported dementia during the programs’ intake assessment—a process completed for all individuals who request meals from these 3 MOW programs.... | PMC10733798 | |
Randomization | The statistician (R.G.) generated a 1:1 stratified, permuted, block randomization scheme, in which each block comprised 6 participants. | PMC10733798 | ||
Interventions | Participants randomized to daily-delivered meals were to receive 5 lunchtime meals delivered to their homes, 2 to 5 times per week, by an MOW program volunteer or a paid driver who interacted with the participant and provided an informal wellness check (all employees/volunteers are asked by programs to report any conce... | PMC10733798 | ||
Measures and Primary Study Outcome | To examine feasibility, we tracked enrollment, examined baseline characteristics between the randomized arms, monitored participants’ fidelity to the intervention, measured the proportion of participants who we were able to link with CMS data, and analyzed the primary study outcome. Participants’ demographics (ie, age,... | PMC10733798 | ||
Adverse Events | deaths | BROWN | Participant deaths, while expected and not related to the intervention, were tracked by the research team. All deaths were reported to the safety officer, the Brown University institutional review board, and the National Institute on Aging program officer for review and oversight. | PMC10733798 |
Linking Data | Outcome data were obtained by linking enrolled participants with CMS administrative data, which were obtained through a study-specific data use agreement that included the 2021 to 2022 Medicare Master Beneficiary Summary File (MBSF) and the 2021 to 2022 Minimum Data Set. | PMC10733798 | ||
Sample Size and Power | Given that this was a pilot study, the target sample size was not based on power but rather on available funds to provide meals for 6 months to enrolled participants. Assuming that the proportions of participants who would be admitted to nursing homes in 6 months were 11% in the daily-delivered arm and 13% in the drop-... | PMC10733798 | ||
Statistical Analysis | death | REGRESSION, EVENT | We used an intention-to-treat analysis; all participants were observed until death, outcome event, or end of the 6-month follow-up. We examined baseline demographic characteristics using data provided by programs. We examined differences in our primary study outcome, time to nursing home admission, between the 2 interv... | PMC10733798 |
Results | Study-specific IDs of 325 prospective enrollees who met inclusion criteria were sent to the research team and were randomized between April and October 2021 ( | PMC10733798 | ||
CONSORT Diagram | CONSORT indicates Consolidated Standards of Reporting Trials. | PMC10733798 | ||
Demographic Characteristics of Individuals Randomized by Enrollment Status | The difference between individuals who were enrolled and those who were randomized but not enrolled was significant at Other race and ethnicity includes Asian, multiracial, and “other,” as reported by the programs. Results for those categorized as other were combined because the small numbers could result in participan... | PMC10733798 | ||
Time From Randomization to Nursing Home Placement by Study Arm | Survival probability for mortality and nursing home placement were derived from Centers for Medicare & Medicaid Services data and observed 6 months from randomization (hazard ratio, −0.67; 95% CI, −1.52 to 0.19). The number at risk represents the average across linkage imputations. Not all 16 individuals were linked in... | PMC10733798 | ||
Discussion | dementia | This pilot study demonstrated the feasibility of implementing a pragmatic randomized clinical trial among participants with self- or proxy-reported dementia on waiting lists at MOW programs. We also showed the ability to link participants with their CMS data, monitor fidelity, and measure the time to nursing home place... | PMC10733798 | |
Limitations | dementia | Consistent with the pragmatic design, this study relied on self-reported and proxy-reported information to identify individuals with dementia. Using information that programs typically collect, this pilot is more generalizable than a study that requires a confirmed diagnosis. Future research should validate this self-r... | PMC10733798 | |
Conclusions | dementia | The findings of this pilot clinical trial demonstrated the feasibility of conducting an embedded pragmatic trial within MOW programs, enrolling older adults with dementia, monitoring their fidelity, linking data, and measuring participants’ outcomes. Although there was lower nursing home placement among participants re... | PMC10733798 | |
Background | esophageal and gastric cardia cancers | COMPLICATIONS | Chemoradiotherapy complications has always been of great concern to both clinicians and patients during the course of treatment. The purpose of the present study was to examine the effectiveness of oral famotidine on the reduction of hematologic complications of patients with esophageal and gastric cardia cancers under... | PMC10199581 |
Methods | anemia, esophageal and cardia cancers | THROMBOCYTOPENIA, ANEMIA, GRANULOCYTOPENIA, LYMPHOCYTOPENIA | A single-blind controlled trial was conducted on 60 patients with esophageal and cardia cancers, who were undergoing chemoradiotherapy. Patients were randomly assigned to 2 groups with 30 patients to receive either 40 mg of oral famotidine (daily and 4 h before each session) or placebo. Complete blood count with differ... | PMC10199581 |
Results | thrombocytopenia | THROMBOCYTOPENIA | The findings indicated a significant effect of famotidine on reduction of thrombocytopenia among intervention group compared to control group ( | PMC10199581 |
Keywords | PMC10199581 | |||
Background | dysphagia, nausea,, Cancer, death, toxicity, cancer, thrombocytopenia, cardia, esophageal cancers, nausea, fatigue, vomiting, anemia, lymphopenia, hypotension, weight loss, cancers, micronuclei, dermatitis | ESOPHAGEAL CANCER, DYSPHAGIA, CANCERS, CARDIOVASCULAR DISEASES, CANCER, THROMBOCYTOPENIA, MINOR, DNA DAMAGE, ESOPHAGITIS, GRANULOCYTOPENIA, LYMPHOPENIA, ANEMIA, CHROMOSOMAL ABERRATIONS, DERMATITIS, COMPLICATIONS, CANCER | According to recent estimates, by 2025 the prevalence of cancer is expected to soar by 45% in developed countries. Cancer is the second cause of death worldwide following cardiovascular diseases. More than one million cases of gastric cardia and 450,000 cases of esophageal cancers are being diagnosed annually, which ar... | PMC10199581 |
Methods and materials | PMC10199581 | |||
Trial design and participants | esophageal and gastric cardia cancers | This was a single center, parallel designed (1:1), single-blind randomized placebo-controlled trial performed on patients with esophageal and gastric cardia cancers who were referred to the radiation oncology clinic of the Vali-E-asr Hospital, Zanjan, Iran, from September 2020 to December 2021. | PMC10199581 | |
Ethical considerations | The present study was approved by the Ethics Committee of Zanjan University of Medical Sciences [IR.ZUMS.REC.1399.158]. Written informed consent was obtained from all participant. Patients entered the study with their full awareness and willingness. Patients could withdraw from the study at any time. The medicine used ... | PMC10199581 | ||
Eligibility criteria | cardia cancers, Death, non-metastatic esophageal | TREATMENT COMPLICATIONS, RENAL IMPAIRMENT | The inclusion criteria were considered the patients aged ≥ 18 years with non-metastatic esophageal and cardia cancers who were candidates for chemo-radiotherapy and did not receive Proton pump inhibitors (PPIs) and other H2-blockers.Death during the study, being unable to continue treatment due to the severity of treat... | PMC10199581 |
Interventions | esophageal and cardia cancers | COMPLICATIONS | This trial was designed to determine the effectiveness of oral famotidine on reducing the acute hematological complications of radiotherapy among patients with esophageal and cardia cancers. All patients received a fixed therapeutic dose of external beam radiation therapy. 15MV high-energy photon from linear accelerato... | PMC10199581 |
Outcomes | cancer, anemia | LYMPHOCYTOPENIA, CANCER, THROMBOCYTOPENIA, ANEMIA, GRANULOCYTOPENIA, COMPLICATIONS | Acute hematological complications of radiotherapy including lymphocytopenia, granulocytopenia, thrombocytopenia, and anemia were the outcome variables of the study that were assessed once at baseline and then weekly at the end of each week using complete blood count (CBC) with differential at the laboratory of Vali-e-A... | PMC10199581 |
Sample size | The sample size was determined based on the study of Razzaghdoust et al. [ | PMC10199581 | ||
Randomization and blinding | Participants, laboratory staff, data collectors, outcome assessors were blinded by not informing them of the group allocations. Data analysts were blinded by providing them with a blinded version of the data. The principal Investigator was aware of treatment assignments. Random sequence of participants was made using B... | PMC10199581 | ||
Statistical analyses | Shapiro–Wilk test was used to test the normality of the numeric data. Mean ± standard deviation (SD), median (IQR) and frequency (%) were used to report descriptive statistics, as applicable. Between-group comparisons were examined using Mann–Whitney U test and independent samples t-test with mean difference (MD) and 9... | PMC10199581 | ||
Results | PMC10199581 | |||
Basic characteristics of the participants | esophageal cancer, gastric cardia adenocarcinomas, SD, squamous cell carcinoma and, adenocarcinoma | OESOPHAGEAL CANCER | A total of 60 patients (32 male, 28 female) with stage I–III esophageal cancer including squamous cell carcinoma and adenocarcinoma, in addition to stage I–III Siewert type I esophagogastric junction (EGJ) and gastric cardia adenocarcinomas were included in the study.With regard to the gender ratio of the participants,... | PMC10199581 |
Discussion | tumor, micronucleus, lymphocytopenia, thrombocytopenia, micronuclei, esophageal cancers, spermatogenesis, gastric cardia, prostate cancer, radiation-induced micronucleus | ESOPHAGEAL CANCER, TUMOR, ASPERMATOGENESIS, LYMPHOCYTOPENIA, THROMBOCYTOPENIA, DNA DAMAGE, CHROMOSOMAL ABNORMALITIES, PROSTATE CANCER, COMPLICATIONS | In the current study we assessed the effectiveness of oral famotidine as a redioprotective agent in reducing hematological complications of radiotherapy among a population of patients with gastric cardia and esophageal cancers. Our findings revealed that there was a significant reduction in thrombocytopenia in the famo... | PMC10199581 |
Conclusion | cancer, thrombocytopenia | CANCER, THROMBOCYTOPENIA | Our findings proved that famotidine was an effective radioprotector in terms of the lymphocyte and platelet counts, so that at the end of the study patients in famotidine group showed significantly higher frequencies of lymphocytes and platelets. Besides, in the famotidine group, a significant reduction in thrombocytop... | PMC10199581 |
Acknowledgements | Not applicable. | PMC10199581 | ||
Author contributions | ZKM, OY, AZ, and AS designed the study. ZKM, OY and MR provided the data and performed data analyses and quality control. ZKM supervised the study. MR conducted the statistical analysis. MR wrote the main manuscript text. MR prepared all figures. ZKM takes responsibility for the paper as a whole. All authors reviewed t... | PMC10199581 | ||
Funding | This study was performed without funding. | PMC10199581 | ||
Availability of data and materials | The datasets used and analyzed during the current study are available from the corresponding author on reasonable request. | PMC10199581 | ||
Declarations | PMC10199581 | |||
Ethics approval and consent to participate | This study was conducted in compliance with the Declaration of Helsinki and guidelines on Good Clinical Practice and was conducted with the approval of the Ethics Committee of Zanjan University of Medical Sciences [IR.ZUMS.REC.1399.158], and a written informed consent was obtained from all participants. | PMC10199581 | ||
Consent for publication | Not applicable. | PMC10199581 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10199581 | ||
References | PMC10199581 | |||
Key Points | PMC10698621 | |||
Question | colorectal cancer | COLORECTAL CANCER, LIVER METASTASES | Is microsatellite-stable or mismatch repair–proficient advanced colorectal cancer with liver metastases (LM) resistant to immune checkpoint inhibitors? | PMC10698621 |
Findings | DISEASE, SECONDARY | In this secondary analysis of a randomized clinical trial of 180 patients, those without LM had significantly improved progression-free and overall survival. In patients without LM, durvalumab and tremelimumab treatment was associated with improved progression-free survival and disease control rate, not overall surviva... | PMC10698621 | |
Meaning | colorectal cancer | LIVER METASTASIS, COLORECTAL CANCER, SECONDARY | Future clinical trials of immune checkpoint inhibitors in microsatellite-stable or mismatch repair–proficient advanced colorectal cancer should stratify patients according to the presence of LM and focus on understanding the mechanism of resistance by LM.This secondary analysis of a randomized clinical trial investigat... | PMC10698621 |
Importance | COLORECTAL CANCER, LIVER METASTASES | Immune checkpoint inhibitors (ICIs) have limited activity in microsatellite-stable (MSS) or mismatch repair–proficient (pMMR) colorectal cancer. Recent findings suggest the efficacy of ICIs may be modulated by the presence of liver metastases (LM). | PMC10698621 | |
Objective | COLORECTAL CANCER | To investigate the association between the presence of LM and ICI activity in advanced MSS colorectal cancer. | PMC10698621 | |
Design, Setting, and Participants | treatment-refractory colorectal cancer, Cancer | SECONDARY, CANCER | In this secondary analysis of the Canadian Cancer Trials Group CO26 (CCTG CO.26) randomized clinical trial, patients with treatment-refractory colorectal cancer were randomized in a 2:1 fashion to durvalumab plus tremelimumab or best supportive care alone between August 10, 2016, and June 15, 2017. The primary end poin... | PMC10698621 |
Intervention | Durvalumab plus tremelimumab or best supportive care. | PMC10698621 | ||
Main Outcomes and Measures | tumor, death | REGRESSION, TUMOR, SECONDARY, DISEASE | Hazard ratios (HRs) and 90% CIs were calculated based on a stratified Cox proportional hazards regression model. Plasma tumor mutation burden at study entry was determined using a circulating tumor DNA assay. The primary end point of the study was OS, defined as the time from randomization to death due to any cause; se... | PMC10698621 |
Results | Of 180 patients enrolled (median age, 65 [IQR, 36-87] years; 121 [67.2%] men; 19 [10.6%] Asian, 151 [83.9%] White, and 10 [5.6%] other race or ethnicity), LM were present in 127 (70.6%). For patients with LM, there was a higher proportion of male patients (94 of 127 [74.0%] vs 27 of 53 [50.9%]; | PMC10698621 | ||
Conclusions and Relevance | colorectal cancer | SECONDARY, LIVER METASTASES, COLORECTAL CANCER | In this secondary analysis of the CCTG CO.26 study, the presence of LM was associated with worse outcomes for patients with advanced colorectal cancer. Patients without LM had improved PFS and higher DCR with durvalumab plus tremelimumab. Liver metastases may be associated with poor outcomes of ICI treatment in advance... | PMC10698621 |
Introduction | cancer, deaths, Colorectal cancer, colorectal cancer | CANCER, COLORECTAL CANCER, COLORECTAL CANCER, METASTATIC DISEASE | Colorectal cancer is the third most commonly diagnosed cancer and the second leading cause of cancer-related mortality worldwide. In 2020, approximately 1.93 million patients were diagnosed with colorectal cancer, resulting in 935 000 deaths.Recent findings suggest that advanced colorectal cancer with metastatic diseas... | PMC10698621 |
Methods | treatment-refractory, colorectal cancer, death, Cancer | COLORECTAL CANCER, CANCER | The Canadian Cancer Trials Group (CCTG) CO.26 study is a phase 2 study that randomized 180 patients with treatment-refractory advanced colorectal cancer unselected for MSI status to durvalumab, an antibody against programmed death ligand 1, plus tremelimumab, an antibody against the cytotoxic T-cell lymphocyte antigen-... | PMC10698621 |
Statistical Analysis | tumor | REGRESSION, SECONDARY, TUMOR | For this retrospective secondary analysis performed from February 11 to 14, 2022, patients were divided into groups based on the presence or absence of LM and study treatments. Cohorts with and without LM were based on radiological findings at the time of study entry. Plasma tumor mutation burden (pTMB) was determined ... | PMC10698621 |
Results | A total of 180 patients were enrolled and randomized, with 119 patients in the durvalumab plus tremelimumab group and 61 in the BSC group. The median age was 65 years (range, 36-87 years); there were 121 men (67.2%) and 59 women (32.8%). In terms of race and ethnicity, 19 patients (10.6%) were Asian, 151 (83.9%) were W... | PMC10698621 | ||
Study Flow Diagram | PMC10698621 | |||
Baseline Characteristics of the Intention-to-Treat Population | tumor | ONCOLOGY, TUMOR, LIVER METASTASES | Abbreviations: ECOG, Eastern Cooperative Oncology Group; EGFR, epidermal growth factor receptor; LM, liver metastases.Unless otherwise indicated, data are expressed as No. (%) of patients.Includes American Indian or Alaska Native, Black, Native Hawaiian or Other Pacific Islander, and unknown race or ethnicity.Scores ra... | PMC10698621 |
Univariate Analysis of OS and PFS by Treatment and Presence of LM | DISEASE, LIVER METASTASES | Abbreviations: DCR, disease control rate; HR, hazard ratio; LM, liver metastases; NA, not applicable; OR, odds ratio; OS, overall survival; PFS, progression-free survival. | PMC10698621 | |
Survival by Treatment Groups and Presence of Liver Metastases | Error bars indicate 90% CIs. BSC indicates best supportive care.On univariable analysis, there were no differences in OS between the durvalumab plus tremelimumab and BSC groups, regardless of LM, and a test of interaction was negative. Progression-free survival was improved with in the durvalumab plus tremelimumab grou... | PMC10698621 | ||
Subgroup Analysis of Overall Survival (OS) and Progression-Free Survival (PFS) in Multivariable Analysis | tumor | TUMOR | BSC indicates best supportive care; HR, hazard ratio; pTMB, plasma tumor mutation burden. | PMC10698621 |
Discussion | colorectal cancer, small-cell lung cancer, melanoma | COLORECTAL CANCER, MELANOMA, MULTIPLE CANCER, MALIGNANT NEOPLASM, MALIGNANT NEOPLASMS, METASTATIC DISEASE, HEPATOCELLULAR CARCINOMA AND CHOLANGIOCARCINOMA, METASTATIC DISEASE | Metastatic disease involving the liver is common in advanced solid malignant neoplasms. The proportion of patients with LM is particularly high in advanced colorectal cancer, with approximately 70% having liver involvement either alone or in combination with other sites of metastatic disease.The presence of LM is assoc... | PMC10698621 |
Limitations | This study has some limitations. Our analysis was unplanned and exploratory in nature. Additionally, it had limited statistical power because there were only 53 patients without LM. Studies reporting differential impact with regard to the presence of LM are heterogeneous. It is possible that different ICIs may have dif... | PMC10698621 | ||
Conclusions | LMs | SECONDARY, LIVER METASTASES, COLORECTAL CANCER | In this secondary analysis of the CCTG CO.26 trial, LMs were associated with worse survival outcomes among patients with advanced colorectal cancer. Liver metastases should be considered in the design and interpretation of future clinical studies evaluating ICI therapy. | PMC10698621 |
Abstract | PMC9991501 | |||
Objective | advanced/unresectable, cancer, death | CANCER | First-line pembrolizumab with/without chemotherapy versus chemotherapy was evaluated in programmed death ligand 1 combined positive score ≥1, locally advanced/unresectable or metastatic gastric cancer/gastrooesophageal junction cancer in the KEYNOTE-062 study. We present results for patients enrolled in Asia. | PMC9991501 |
Methods | SECONDARY | Eligible patients were randomly assigned 1:1:1 to pembrolizumab 200 mg, pembrolizumab plus chemotherapy (cisplatin + 5-fluorouracil or capecitabine) or placebo plus chemotherapy Q3W. End points included overall survival (primary) in combined positive score ≥1 and combined positive score ≥10 populations and safety and t... | PMC9991501 | |
Results | A total of 187 patients were enrolled in Asia (pembrolizumab, | PMC9991501 | ||
Conclusions | death, cancer/gastrooesophageal junction cancer | This post hoc analysis showed pembrolizumab monotherapy was associated with numerically improved overall survival and a favourable tolerability profile versus chemotherapy in Asians with programmed death ligand 1–positive advanced gastric cancer/gastrooesophageal junction cancer.This study is registered with Subgroup a... | PMC9991501 | |
Introduction | Gastric cancer, death, gastrooesophageal junction cancer, cancer, cancer death, advanced/metastatic, GEJC | GASTRIC CANCER, GASTROOESOPHAGEAL JUNCTION CANCER, CANCER | Gastric cancer (GC) and gastrooesophageal junction cancer (GEJC) is the fifth most frequently diagnosed cancer and the third leading cause of cancer death globally (The standard of care for the 85% of patients with unresectable, locally advanced/metastatic GC/GEJC in Asia is doublet or triplet fluoropyrimidine- and pla... | PMC9991501 |
Material and methods | PMC9991501 | |||
Trial design, patients and treatment | Full details of the phase 3 KEYNOTE-062 study (All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1964 and later versions. The study protocol and all amendments were approved by the... | PMC9991501 | ||
Assessments and outcomes | Tumour, tumour, Cancer | ADVERSE EVENT, TUMOUR, ADVERSE EVENT, TUMOUR, INFUSION REACTION, CPS, CANCER | Tumour responses were assessed using Response Evaluation Criteria in Solid Tumours, version 1.1 (RECIST v1.1), by blinded independent central review (BICR) every 6 weeks. Adverse events were assessed throughout the study and at 30 days after treatment discontinuation (90 days for serious AEs and immune-mediated AEs and... | PMC9991501 |
Statistical analysis | Efficacy was evaluated in all randomly assigned patients in Asia and safety was evaluated in all randomly assigned patients in Asia who received ≥1 dose of study treatment. OS, PFS and DOR were estimated using the nonparametric Kaplan–Meier method and rules for censoring, and between-arm differences in OS and PFS were ... | PMC9991501 | ||
Results | PMC9991501 | |||
Patients | MAY | Between 18 September 2015, and 26 May 2017, 763 patients (pembrolizumab, Baseline characteristics of patients enrolled in Asia in the KEYNOTE-062 study
| PMC9991501 | |
Efficacy—pembrolizumab monotherapy versus chemotherapy | death | CPS | In the PD-L1 CPS ≥1 population, median OS was 22.7 months (95% CI, 14.3–28.5) with pembrolizumab versus 13.8 months (95% CI, 10.5–16.9) with chemotherapy (HR, 0.54; 95% CI, 0.35–0.82) (Kaplan–Meier estimates of overall survival for patients enrolled in Asia in the KEYNOTE-062 study. Pembrolizumab monotherapy versus che... | PMC9991501 |
Efficacy—pembrolizumab plus chemotherapy versus chemotherapy | CPS | In the PD-L1 CPS ≥1 population, median OS was 16.5 months (95% CI, 12.8–19.6) with pembrolizumab plus chemotherapy versus 13.8 months (95% CI, 10.5–16.9) with chemotherapy (HR, 0.78; 95% CI, 0.53–1.16) (In the PD-L1 CPS ≥1 population, median PFS was 8.5 months (95% CI, 7.0–10.3) with pembrolizumab plus chemotherapy ver... | PMC9991501 | |
Safety—all treatment arms | ADVERSE EVENTS | Treatment-related AEs occurred in 35 of 62 (56.5%), 62 of 62 (100%), and 53 of 57 patients (93.0%) receiving pembrolizumab, pembrolizumab plus chemotherapy and chemotherapy, respectively (Treatment-related adverse events
| PMC9991501 | |
Discussion | tumours, cancers, death | CPS, CANCERS, TUMOURS | In this subpopulation analysis of the phase 3 KEYNOTE-062 trial, first-line pembrolizumab monotherapy was associated with numerically improved OS compared with chemotherapy for patients enrolled in Asia with PD-L1–positive GC/GEJC. A greater benefit was observed with pembrolizumab monotherapy in this subgroup analysis ... | PMC9991501 |
Abbreviations | PD, death, MSI-H | VIRUS, DISEASE, MICROSATELLITE INSTABILITY, EPSTEIN, ADVERSE EVENT, ONCOLOGY, CPS, GASTROOESOPHAGEAL JUNCTION CANCER, GASTRIC CANCER | BICR, blinded independent central review; CPS, combined positive score; CR, complete response; DOR, duration of response; EBV, Epstein–Barr virus; ECOG PS, Eastern Cooperative Oncology Group performance status; ERBB2, Erb-B2 receptor tyrosine kinase 2; GC, gastric cancer; GEJC, gastrooesophageal junction cancer; HER2, ... | PMC9991501 |
Authors’ contribution | Shinichi, Jen-Shi | Conception, design or planning of the study: Yee Chao, Shi Rong Han, Shinichi Shiratori, Sukrut Shah and Kohei ShitaraAcquisition of data: Hironaga Satake, Keun-Wook Lee, Hyun Cheol Chung, Jeeyun Lee, Jen-Shi Chen, Takaki Yoshikawa, Kenji Amagai, Kun-Huei Yeh, Masahiro Goto, Yee Chao, Ka-On Lam and Kohei ShitaraAnalysi... | PMC9991501 | |
Disclosures | Jen-Shi | ONCOLOGY, EVENTS, CROSS | Hironaga Satake reports research funding paid to his institution from Ono Pharmaceutical Co Ltd, Daiichi Sankyo and Taiho Pharmaceutical Co Ltd, and honoraria for lectures from Bristol Myers Squibb Co., Ltd., Bayer Co., Ltd., Chugai Pharmaceutical Co., Ltd, Daiichi Sankyo Co., Ltd., Eli Lilly Japan Co., Ltd., MSD Co., ... | PMC9991501 |
Data sharing | Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA (MSD) is obligated to protect the rights and privacy of trial participants. To fulfil the company’s obligation, MSD has a procedure in place for evaluating and fulfilling requests for sharing company clinical trial data with qualified external ... | PMC9991501 | ||
Funding | Funding for this study was provided by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. Grant number not applicable. | PMC9991501 | ||
Supplementary Material | Click here for additional data file.Click here for additional data file. | PMC9991501 | ||
Acknowledgements | The authors thank the patients and their families and caregivers as well as the primary investigators and site personnel for participating in the study. Medical writing and/or editorial assistance was provided by Holly C. Cappelli, PhD, CMPP, of ApotheCom (Yardley, PA, USA). This assistance was funded by MSD K.K., Toky... | PMC9991501 | ||
References | PMC9991501 | |||
Background | strabismus | STRABISMUS, INTRAOCULAR PRESSURE | It is well-established that maintaining stable intraocular pressure (IOP) within the normal range during ophthalmic surgery is important. Esketamine is a commonly used drug in pediatric general anesthesia due to its good analgesic and sedative effects. However, its application in ophthalmic surgery is limited because i... | PMC10426143 |
Methods | strabismus | STRABISMUS | A total of 181 children with strabismus undergoing unilateral eye surgery under general anesthesia were recruited. Intravenous induction included the use of sufentanil 0.1 µg/kg, propofol 3 mg/kg, and esketamine. Base on the dosage of esketamine, the patients were randomly allocated into three groups: esketamine low (E... | PMC10426143 |
Results | There were no significant differences in age, gender, body mass index (BMI), and respiratory parameters among the three groups at T | PMC10426143 | ||
Conclusion | strabismus | STRABISMUS | Propofol combined with sufentanil significantly decreased IOP during the induction of general anesthesia. Although a dose of 0.5 mg/kg esketamine elevated IOP compared to the low-dose and control groups after induction, the IOP remained lower than baseline. 0.25 mg/kg esketamine combined with propofol and sufentanil ha... | PMC10426143 |
Trial registration | The registration number is ChiCTR2200066586 at Chictr.org.cn. Registry on 09/12/2022. | PMC10426143 | ||
Keywords | PMC10426143 | |||
Introduction | sudden increase, Strabismus, retinal detachment, choroidal edema, nausea, vomiting | STRABISMUS, PROLAPSE, CENTRAL RETINAL ARTERY OCCLUSION, LOW INTRAOCULAR PRESSURE, COMPLICATIONS, RETINAL DETACHMENT, DISEASES, INTRAOCULAR PRESSURE | Stable intraocular pressure is beneficial for maintaining the shape and function of the eyeball, essential for the prognosis of patients undergoing ophthalmic surgery or those with ophthalmic diseases. The sudden increase in intraocular pressure during the induction period can lead to nausea, vomiting, central retinal ... | PMC10426143 |
Materials and methods | PMC10426143 | |||
Study population | retinopathy, allergic, keratopathy, upper respiratory tract infection, strabismus, glaucoma | RETINOPATHY, UPPER RESPIRATORY TRACT INFECTIONS, KERATOPATHY, STRABISMUS, NEUROMUSCULAR DISEASE, GLAUCOMA, EYE | The institutional review board of Tianjin Eye Hospital approved this prospective, randomized, double-blind study, registered in the Chinese Clinical Trial Registry on 09/12/2022 (ChiCTR2200066586). Guardians of all participants signed informed consent after obtaining a detailed understanding of the study objectives, pr... | PMC10426143 |
Study methods | Using a random number table created by statisticians using SPSS statistical software, 181 patients were allocated into three groups: esketamine low (EL) group, esketamine high (EH) group, and normal saline (NS) group. All patients had routine fasting for 8 h and liquid fasting for 2 h before surgery. Penehyclidine hydr... | PMC10426143 | ||
Data collection | INTRAOCULAR PRESSURE | Preoperative general indicators included age, gender, weight, body mass index (BMI), and ASA classification. Systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), tidal volume (VT), PETCOThe primary outcome of this study is IOP. IOP at each time point was measured by a skilled ophthalmologist ... | PMC10426143 |
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