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2.4. Study Assessment and Outcomes | Eligible participants completed a clinic assessment visit and faecal sample collection (for gut microbiome analysis) at the start (weeks 0 and 16) and at the end (weeks 8 and 24) of each diet intervention phase. To determine the effect of a MedDairy diet on the gut microbiota, changes to the gut microbiota between base... | PMC10459086 | ||
2.5. Dietary Adherence | Dietary adherence was assessed and reported previously [ | PMC10459086 | ||
2.6. Faecal Microbiome Analysis | EBOS | Faecal sample collection was performed in an OMNIgene GUT stool collection kit (DNA Genotek, Ottawa, ON, Canada) for sample preservation, according to instructions provided by the manufacturer, and using a disposable urine collection hat (EBOS Healthcare, Kingsgrove, NSW, Australia). Samples were returned to the labora... | PMC10459086 | |
2.7. Statistical Analyses | Baseline participant demographics between dietary groups were statistically compared using an unpaired All microbiome data were checked for normality using the Shapiro–Wilks method. Changes in overall microbial alpha diversity measures were analysed using the Wilcoxon sign-rank or Mann–Whitney The association between c... | PMC10459086 | ||
2.8. Power Calculation | The initial sample size calculation was based on the ability to detect a clinically relevant difference of 2.5 mmHg in systolic blood pressure (primary study outcome) at a power of 90% and | PMC10459086 | ||
3. Results | Of the 43 participants randomised, 41 commenced the diet schedule and 37 continued to completion ( | PMC10459086 | ||
3.1. Effects of Diet Intervention on the Overall Faecal Microbiota Structure and Composition | No significant changes in bacterial richness and evenness were evident after the MedDairy or LFD diet study arms (The potential for effects resulting from the MedDairy or LFD intervention at Phase 1 to affect baseline measures at Phase 2 (following the 8-week washout period) was investigated. Carryover effects from Pha... | PMC10459086 | ||
3.2. Differential Effects between MedDairy and Low-Fat Diets on Specific Gut Bacteria | While the broad characteristics of the faecal microbiota remained unaltered by MedDairy or LFD, changes were observed at the level of individual bacteria taxa. Following the 8-week MedDairy intervention, significant changes were observed for several bacterial taxa, including increases in the relative abundance of | PMC10459086 | ||
3.3. Gut Bacteria Changes Were Associated with Diet and Clinical Outcomes | Associations between changes in altered bacterial taxa and changes in clinical, anthropometric, and cognitive measures were determined by correlation analysis (Correlation analysis based on both interventions (MedDairy and LFD) indicates that a higher relative abundance of The changes in relative abundance of | PMC10459086 | ||
4. Discussion | CVD | This study sought to explore the effects of an 8-week Mediterranean diet enriched with dairy products (to reach the recommended Australian dietary intake of 1000–1300 mg of calcium) on the gut microbiome of Australian adults at risk of CVD. The dairy enrichment involved 3–4 daily servings of any of the following dairy ... | PMC10459086 | |
Supplementary Materials | The following supporting information can be downloaded at: Click here for additional data file. | PMC10459086 | ||
Author Contributions | K.J.M., J.M.H., A.T.W. and C.R.D. designed the project and secured funding. K.A.D. contributed to the project design. K.J.M., A.T.W., K.A.D. and C.R.D. conducted the trial and collected study data. K.J.M. and C.R.D. developed the diet. J.M.C. and Y.W. performed the gut microbiome analysis. J.M.C. and Y.W. developed and... | PMC10459086 | ||
Data Availability Statement | Raw sequence data are publicly accessible from the Sequence Read Archive repository using the BioProject ID PRJNA996323 and at | PMC10459086 | ||
Conflicts of Interest | The authors declare no conflict of interest. The funding sponsor, Dairy Australia, had no role in the design of the study or the preparation of the manuscript. | PMC10459086 | ||
References | cardiovascular disease | CARDIOVASCULAR DISEASE | Flow diagram of the cross-over study involving an 8-week MedDairy and an 8-week low-fat diet intervention in adults with cardiovascular disease risk. Adapted from Wade et al., 2018 [Alpha diversity measures of (Alterations in bacterial relative abundance following 8 weeks of the MedDairy diet. ((Demographic and clinica... | PMC10459086 |
Background | seroma, bleeding, hernia | BLEEDING, SEROMA, POSTOPERATIVE COMPLICATION, COMPLICATIONS | Open mesh repair of incisional hernia is associated with different local complications, particularly bleeding and seroma formation. Traditionally, drains have been placed perioperatively to prevent these complications, despite the lack of scientific evidence or expert consensus. We formulated the hypothesis that the ab... | PMC9803733 |
Methods | SECONDARY, OTHER COMPLICATION | Prospective randomized study using standardized surgical technique and drain placement. The primary endpoint was the evaluation of residual fluid collection with ultrasound on postoperative day 30. Other complications, subdivided into medical and surgical, were analyzed as secondary endpoints. | PMC9803733 | |
Results | There were 144 patients randomized (70 with drain, 74 without drain). No difference was identified between both groups for fluid collection at 30 days (60.3% vs. 62%, | PMC9803733 | ||
Conclusions | hernia | Prophylactic drainage in open incisional hernia repair does not objectively reduce the rate of postoperative fluid collections. Therefore, our results do not support the use of routine drainage in incisional hernia repair. | PMC9803733 | |
Trial registration | Trial registration on clinicaltrials.gov (NCT00478348). | PMC9803733 | ||
Supplementary Information | The online version contains supplementary material available at 10.1007/s00268-022-06725-4.Open access funding provided by University of Lausanne | PMC9803733 | ||
Introduction | hernia | SITE INFECTION, COMPLICATIONS | Incisional hernia formation presents a major burden of care after open abdominal surgery. It may occur in up to 20% of patients after median laparotomy [The most common complications after open mesh incisional hernia repairs are surgical site infections and collections [Indeed there are few prospective studies comparin... | PMC9803733 |
Material and methods | PMC9803733 | |||
Compliance with ethical standards | This prospective randomized multicentric study was conducted according to the CONSORT statement guidelines [ | PMC9803733 | ||
Patients | strangulated hernia, hernia | Patients were screened preoperatively at the outpatient clinic of the Department of visceral surgery, Lausanne University Hospital CHUV. Inclusion criteria were patients between 20 and 80 years old requiring an elective open incisional hernia repair with a physical status classification according to the American Societ... | PMC9803733 | |
Sample size calculation | hernia, hematoma, seroma | RECURRENCE, SURGICAL SITE INFECTION, COMPLICATION, SEROMA, HEMATOMA, COMPLICATIONS | The complication rate in the drainage group was estimated to reach 20%. No prospective study comparing drainage and without drainage was available in the literature when the study was started. Rates of complications were estimated according to a consensus between surgeons participating to the study. We hypothesized tha... | PMC9803733 |
Surgical techniques and randomization | BLIND | Patients were electronically randomized on the day before surgery. They were allocated to the treatment group (with drainage) or the control group (without drainage). A clinical nurse performed the randomization through a web-based service (This study was not blinded due to technical limitations. Indeed, it would have ... | PMC9803733 | |
Endpoints | Seroma, hematoma, seroma, abscess | ABSCESS, SEROMA, HEMATOMA, SEROMA, COMPLICATIONS | The endpoints were registered during a follow up period of thirty days. The primary endpoint was the presence of a fluid collection on postoperative day 30 (POD 30). All patients underwent an ultrasound to objectively assess the presence or absence of a collection. Collections were subdivided into seroma, hematoma and ... | PMC9803733 |
Statistical analysis | COMPLICATIONS | The null hypothesis was the absence of difference between both groups and the alternative hypothesis was a decrease of complications without drain. The normal distribution of the variables was assessed with a Kolmogorov–Smirnov test. Continuous variables were analyzed with a Student’s t-test and categorial binary varia... | PMC9803733 | |
Results | PMC9803733 | |||
Endpoints | SITE INFECTION, DISEASE | The rate of fluid collection at POD 30, which was defined as the primary endpoint, was high in both groups, but the difference between both groups (60.3% drain group vs. 62.0% no drain group, Operative and postoperative characteristicsSurgical site infection according to Center for Disease Control and Prevention (CDC) ... | PMC9803733 | |
Follow up | The follow up was complete for all patients, with a clinical and radiological control at POD 30. | PMC9803733 | ||
Discussion | seroma, hernia | MINOR, SURGICAL SITE INFECTION, RECRUITMENT, COMPLICATION, SECONDARY, SURGICAL COMPLICATIONS, SEROMA, COMPLICATIONS | This prospective randomized study assessed the role of intraoperatively placed drains to avoid postoperative fluid collection after open incisional hernia repair. Postoperative fluid collections were observed in both groups in up to 65% of patients, and drain placement could not decrease the incidence of that particula... | PMC9803733 |
Conclusion | hernia | Prophylactic drainage in open incisional hernia repair does not objectively reduce the rate of postoperative fluid collections. Therefore, our results do not support the use of routine drainage in incisional hernia repair. | PMC9803733 | |
Acknowledgements | RECRUITMENT | The authors would like to thanks Dr Paroz A., Dr Vuilleumier H. and Dr Donadini A. for their respective contribution to the study, regarding the design, the implementation and patient’s recruitment. The authors declare that they have no conflict of interest. Abdominal wall ultrasound carried out systematically on post-... | PMC9803733 | |
Funding | Open access funding provided by University of Lausanne. | PMC9803733 | ||
Declarations | PMC9803733 | |||
Conflict of interest | The authors declare no conflict of interest. | PMC9803733 | ||
Ethical approval | Abdominal wall ultrasounds carried out systematically on post-operative day 30 were supported by the research fund of the Visceral Surgery Department of Lausanne University Hospital CHUV, Lausanne, Switzerland. The study was approved by the local ethics committee (CER-VD 31/07, DP-2007-CHV-UNIL) and was registered as a... | PMC9803733 | ||
Informed consent | Informed consent was obtained from all individual participants included in the study. | PMC9803733 | ||
References | PMC9803733 | |||
Objective | hypotension | Academic Editor: V. E. Sathishkumar The aim of the study is to explore the clinical effect of dexmedetomidine combined with low-dose norepinephrine (NE) continuous pumping in preventing supine hypotension. | PMC9922180 | |
Methods | A total of 160 puerperaes who underwent elective cesarean section were selected. The puerperaes were equally divided into | PMC9922180 | ||
Results | bleeding | BLEEDING | There were no statistically significant differences in the age, gestational age, body mass index, bleeding volume, fluid supplement volume, Apgar scores of new borns at the 1st and 5th minute, the blood gas values of umbilical cord arterial and venous in the four groups ( | PMC9922180 |
Conclusion | hypotension | ADVERSE REACTIONS, ADVERSE EFFECTS | Dexmedetomidine combined with continuous pumping of low-dose norepinephrine can effectively prevent the occurrence of supine hypotension, reduce the occurrence of other adverse reactions, and have no obvious adverse effects on neonates. | PMC9922180 |
1. Introduction | SUPINE HYPOTENSION SYNDROME, UTERUS | Intraspinal anesthesia has always been the first choice for cesarean section. However, after the full-term parturient is anesthetized in spinal canal, the foil effect of abdominal muscles on the uterus is eliminated. In supine position, the enlarged uterus oppresses the inferior vena cava and abdominal aorta. At the sa... | PMC9922180 | |
2. Materials and Methods | PMC9922180 | |||
2.1. General Information | congenital malformations, fetal distress | PRETERM DELIVERY, CARDIOVASCULAR DISEASE, FETAL DISTRESS | This study selected 160 healthy singleton mothers aged 20–35 who underwent elective cesarean section in Wuhu Second People's Hospital from August, 2019, to August, 2021. Participants with cardiovascular disease, fetal congenital malformations, fetal distress and preterm delivery, and participants who have intraspinal a... | PMC9922180 |
2.2. Study Protocol and Intervention | hypotension | After all the eligible parturients entered the operating room, venous passage of the upper limb was established, and the left radial artery catheterization was performed under local anesthesia, and BP, HR, EKG and SpOAfter intrathecal injection of 10 min, the maternal sensory block level was measured by acupuncture met... | PMC9922180 | |
2.3. Outcome Measures | bleeding, nausea, chest tightness, hypotension, shivering | ADVERSE REACTIONS, REACTIVE HYPERTENSION, SECONDARY, BLEEDING | The primary outcome was defined as the additional dose of NE and the secondary outcome was defined as other indicators of puerperaes and neonates, including the incidence of maternal hypotension. General condition of parturient: age, gestational age, body mass index, volume of bleeding and fluid replacement; interventi... | PMC9922180 |
2.4. Statistical Analysis | Statistical analysis was performed using SPSS 25.0 software. All data were tested by | PMC9922180 | ||
3. Results | PMC9922180 | |||
3.1. Baseline Information and Indicators | The combination of Apgar score and fetal umbilical artery blood gas analysis is considered to be the criterion for judging the state of newborns [ | PMC9922180 | ||
3.2. Incidence of Hypotension, Additional NE, and Adverse Events | ADVERSE REACTIONS, REACTIVE HYPERTENSION | Compared with group As shown in The incidence of adverse reactions in the dexmedetomidine group, noradrenalin group, and dexmedetomidine combined with noradrenalin group was significantly lower than that in the saline group, and the incidence of adverse reactions in dexmedetomidine combined with noradrenalin group was ... | PMC9922180 | |
4. Discussion | bradycardia, postoperative chills, anxiety, nausea and vomiting, pain, hypotension | ADVERSE EFFECTS, MUSCLE RELAXATION, COMPLICATIONS | Cesarean section is an important procedure in modern obstetrics. It is of great significance to relieve the anxiety and tension of parturient and reduce the pain and complications of cesarean section patients during perioperative period. Because of the particularity of cesarean section, in order to avoid adverse effect... | PMC9922180 |
5. Limitation | Although this study has a certain clinical significance, it has certain limitations, and the follow-up needs to be further confirmed by a large-sample, multicenter randomized controlled trial. | PMC9922180 | ||
6. Conclusion | hypotension | ADVERSE REACTIONS, ADVERSE EFFECT | To sum up, in the healthy women who underwent elective cesarean section, continuous infusion of dexmedetomidine combined with low-dose norepinephrine can effectively maintain the circulatory stability of patients during operation, effectively prevent hypotension in the supine position, and reduce the incidence of other... | PMC9922180 |
Data Availability | The datasets used or analyzed during the current study are available from the corresponding author on reasonable request. | PMC9922180 | ||
Ethical Approval | This study was conducted in accordance with the Declaration of Helsinki and was approved by the ethics committee of our hospital. | PMC9922180 | ||
Consent | All participants had signed the informed consent. | PMC9922180 | ||
Conflicts of Interest | The authors declare that they have no conflicts of interest. | PMC9922180 | ||
Authors' Contributions | blood loss, hypotension | ADVERSE REACTIONS, BLOOD LOSS | Conception and design of the research was done by WSL, ZJ, and CJ. Acquisition of data was done by ZJ, SY, ZF, and CJ. Analysis and interpretation of the data were done by ZJ, SY, and WQF. Statistical analysis was done by ZJ, SY, and WSL. ZJ and SY wrote the manuscript. Critical revision of the manuscript for the intel... | PMC9922180 |
Aim | Cancer | METASTATIC GASTRIC CANCER, CANCER | Edited by: Yuming Jiang, Wake Forest University, United StatesReviewed by: Zibing Wang, Henan Provincial Cancer Hospital, China; Lu Han, Henan Provincial Cancer Hospital, ChinaTo evaluate the safety and initial efficacy of autologous cytokine-induced killer (CIK) cells combined with S-1+oxaliplatin (SOX) as the first-l... | PMC10646377 |
Materials and methods | ADVERSE EVENTS, DISEASE, SECONDARY | In this two-arm, single-center exploratory trial, patients with locally advanced or metastatic GC were randomly assigned (1:1) to receive autologous CIK cells in combination with SOX (CIK-SOX) or SOX alone. The primary endpoint was the incidence of adverse events (AEs). Progression-free survival (PFS), overall survival... | PMC10646377 | |
Results | gastrointestinal reaction, anemia, leucopenia, neutropenia | NEUTROPENIA, THROMBOCYTOPENIA, ANEMIA, LEUCOPENIA, HYPERBILIRUBINEMIA | Fifty-nine patients were enrolled in the study between November 20, 2014 and September 6, 2017. A total of 31 patients received CIK-SOX and 28 patients received SOX. The most common AEs in both groups were gastrointestinal reaction, leucopenia, neutropenia, anemia, thrombocytopenia, hyperbilirubinemia, and elevated asp... | PMC10646377 |
Conclusion | The safety of CIK-SOX as the first-line treatment for patients with locally advanced or metastatic GC was good. Although the PFS and OS in the CIK-SOX group were not statistically significantly different compared to the values in the SOX alone group, this treatment increased the PFS and OS duration, with the absolute i... | PMC10646377 | ||
Clinical trial registration | PMC10646377 | |||
Introduction | Gastric cancer, death | MALIGNANT TUMORS, GASTRIC CANCER | Gastric cancer (GC) is one of the most common malignant tumors. Its incidence ranks fifth in the world, while death rate ranks second, representing a serious threat to people’s life and health (Adoptive cell therapy (ACT) aims to collect human autoimmune cells, expand their number after cultivation At present, a variet... | PMC10646377 |
Patients and methods | PMC10646377 | |||
Study design | toxicity, PD, Cancer | DISEASE, METASTASIS, CANCER | This randomized, open-label, exploratory study was conducted at a single center. Since the main purpose of the study was exploratory, no statistical assumptions were made about the sample size. Patients were randomly assigned (1:1) to receive CIK-SOX or SOX alone using the central randomization system. Randomized group... | PMC10646377 |
Patients | Tumors, gastric adenocarcinoma | TUMORS, GASTRIC ADENOCARCINOMA | Patients with histologically confirmed gastric adenocarcinoma and radiographic diagnosis of locally advanced or metastatic GC were eligible for inclusion. Other inclusion criteria included age of ≥ 18 years old, measurable and/or evaluable lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST) g... | PMC10646377 |
Preparation of autologous CIK cells | CIK cells were derived from the patient’s own peripheral blood. Peripheral blood mononuclear cells were isolated using Ficoll-Hypaque density gradient centrifugation. Mononuclear cells (lymphocytes) were adjusted to a concentration of 2×10 | PMC10646377 | ||
Cell infusion | After 14 days of cultivation, the proportion of obtained CD4, CD8, and NKT cells was as follows: CD3+: 85–98.3%, with an average of 92.6%; CD3+CD8+: 49.6–81.8%, with an average of 68.2%; CD3+CD4+: 9.7–43.5%, with an average of 22.7%; CD3-CD56+: 1–15%, with an average of 6.0%; and CD3+CD56+(NKT): 3.4–27.4%, with an aver... | PMC10646377 | ||
Therapeutic regimen | Patients received SOX alone or in combination with autologous CIK cells every 3 weeks. SOX regimen included oxaliplatin (130 mg/m | PMC10646377 | ||
Assessment | PD, tumor, death | ADVERSE EVENTS, TUMOR, ADVERSE EVENT | Clinical examination and laboratory evaluation were required before each treatment cycle. After baseline assessment, tumor status was assessed using computed tomography scanning and tumor markers every 6 weeks until achieving PD according to the RECIST guideline version 1.1 (Safety was evaluated based on adverse event ... | PMC10646377 |
Statistical analysis | PD, death, SD, tumor | DISEASE, SECONDARY, REMISSION, TUMOR | The purpose of the present study was to explore the safety and effectiveness of the CIK-SOX regimen. The primary end point was the incidence of AEs. The AE evaluation was calculated and classified according to CTCAE v4.0. The secondary end points were progression-free survival (PFS), overall survival (OS), objective re... | PMC10646377 |
Results | PMC10646377 | |||
Patient disposition and characteristics | Tumors | TUMORS, DISEASE, ONCOLOGY | Between November 20, 2014 and September 6, 2017, 62 patients were randomly assigned to receive treatment with CIK-SOX (n=31) or SOX alone (n=31). Three patients in the SOX group withdrew their informed consent and did not start the study treatment. Thus, SS and FAS included 31 patients in the CIK-SOX group and 28 patie... | PMC10646377 |
Treatment exposure | PD | As of December 6, 2017, all 59 patients ceased study therapy, most of them due to PD. Furthermore, 61.3% (19/31) of patients in the CIK-SOX group and 53.5% (15/28) of patients in the SOX group received follow-up chemotherapy, while 12.9% (4/31) and 7.1% (2/28) of patients, respectively, received radical gastrectomy. | PMC10646377 | |
Safety | ADVERSE EVENT |
Adverse events.
SOX, S-1+oxaliplatin; CIK-SOX, CIK cells in combination with SOX; ALT, alanine aminotransferase; AST, aspartate aminotransferase; TBIL total bilirubin; DBIL direct bilirubin; CREA, creatinine.Bold represents P-values with statistical differences. | PMC10646377 | |
PFS and OS | PD | EVENTS | As of December 6, 2019, 46 patients experienced endpoint events (PD) and 10 were censored (six patients received surgical treatment and four were lost to follow-up). Median PFS values were 6.9 months [95% confidence interval (CI), 4.3–8.8] in the CIK-SOX group and 4.9 months [95% CI, 3.6–7.7] in the SOX group (hazard r... | PMC10646377 |
ORR and DCR | PD | DISEASE, REMISSION, BEST | In the efficacy analysis, the investigators determined that 29 patients in the CIK-SOX group and 25 patients in the SOX group had measurable lesions. No patients in the CIK-SOX group achieved CR, while 16 patients achieved PR, and 11 patients achieved SD. The ORR was 55.2% (95% CI, 35.7–73.6%) and DCR was 93.1% (95% CI... | PMC10646377 |
Discussion | tumor | TUMOR, INFILTRATION, METASTASIS | With the development of ICIs, a number of large phase III clinical studies have established the role of ICI combined with chemotherapy in the treatment of locally advanced or metastatic GC patients, but the population-wide data showed limited benefits. It has been hypothesized that one of the reasons for the poor effic... | PMC10646377 |
Conclusions | Autologous CIK cells in combination with SOX demonstrated a good safety profile as the first-line therapy in locally advanced or metastatic GC patients. Although the PFS and OS in the CIK-SOX group were not statistically significantly different compared to those in the SOX alone group, the treatment prolonged the PFS a... | PMC10646377 | ||
Data availability statement | The original contributions presented in the study are included in the article/supplementary material. Further inquiries can be directed to the corresponding author. | PMC10646377 | ||
Ethics statement | Cancer Center/Cancer | The studies involving humans were approved by The Ethics Committee of the National Cancer Center/Cancer Hospital, the Chinese Academy of Medical Sciences and Peking Union Medical College. The studies were conducted in accordance with the local legislation and institutional requirements. The participants provided their ... | PMC10646377 | |
Author contributions | XM: Conceptualization, Data curation, Writing – original draft, Formal Analysis, Methodology, Project administration. LP: Data curation, Formal Analysis, Writing – original draft. JW: Data curation, Formal Analysis, Writing – original draft. LG: Investigation, Writing – original draft. WZ: Investigation, Writing – orig... | PMC10646377 | ||
Acknowledgments | SESSION | The paper was selected by 2023 ASCO Annual Meeting for presentation in a ‘Poster Session’. | PMC10646377 | |
Conflict of interest | Authors XL and JL were employed by the company Beijing Biohealthcare Biotechnology Co., Ltd.The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. | PMC10646377 | ||
Publisher’s note | All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or ... | PMC10646377 | ||
References | PMC10646377 | |||
Background | LAGC, gastric cancer | GASTRIC CANCER | Gastrectomy with D2 dissection and adjuvant chemotherapy is the standard treatment for locally advanced gastric cancer (LAGC) in Asia. However, administering chemotherapy with sufficient intensity after gastrectomy is challenging. Several trials demonstrated the efficacy of neoadjuvant chemotherapy (NAC). However, limi... | PMC10468941 |
Methods | Patients received three cycles of SOX | PMC10468941 | ||
Results | The median age of 26 enrolled patients was 74.5 years. The median DI in NAC-SOX | PMC10468941 | ||
Conclusions | NAC-SOX | PMC10468941 | ||
Supplementary Information | The online version contains supplementary material available at 10.1007/s10147-023-02373-3. | PMC10468941 | ||
Keywords | PMC10468941 | |||
Introduction | gastric cancer, cancer, Cancer | GASTRIC CANCER, CANCER, CANCER | According to the 2020 Global Cancer Observatory Data, gastric cancer (GC) is the 4th most deadly cancer in the world, and most common in East Asia [Gastrectomy with D2 lymph node dissection and postoperative adjuvant chemotherapy is currently the standard treatment for locally advanced GC (LAGC) in Asian countries [The... | PMC10468941 |
Patients and methods | MAY | This multicenter, open-label, single-arm, prospective phase II clinical trial was conducted from June 2018 to May 2020 at 11 institutions in Japan. The study protocol was approved by the Clinical Research Network Fukuoka Certified Review Board. The study was conducted according to the tenets of the Declaration of Helsi... | PMC10468941 | |
Eligibility criteria | neurologic or psychiatric disorders, cancer, liver cirrhosis, hepatitis, esophageal infiltration, gastric adenocarcinoma | CARDIOVASCULAR DISEASE, DRUG HYPERSENSITIVITY, CANCER, LIVER CIRRHOSIS, GASTRIC CANCER, ONCOLOGY, HEPATITIS, GASTRIC ADENOCARCINOMA | All patients had histologically confirmed untreated gastric adenocarcinoma based on an endoscopic biopsy of the primary lesion. The major inclusion criteria were diagnoses of cT3–4, N1–3, and M0 (according to the Japanese Gastric Cancer Classification: 3rd English edition) based on image findings (endoscopy, abdominal ... | PMC10468941 |
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