Comparison of the efficacy and tolerability of elobixibat plus sodium picosulfate with magnesium citrate and split-dose 2-L polyethylene glycol with ascorbic acid for bowel preparation before outpatient colonoscopy: a study protocol for the multicentre, randomised, controlled E-PLUS trial.

BACKGROUND: Sodium picosulfate (SP)/magnesium citrate (MC) and polyethylene glycol (PEG) plus ascorbic acid are recommended by Western guidelines as laxative solutions for bowel preparation. Clinically, SP/MC has a slower post-dose defaecation response than PEG and is perceived as less cleansing; therefore, it is not currently used for major bowel cancer screening preparation. The standard formulation for bowel preparation is PEG; however, a large dose is required, and it has a distinctive flavour that is considered unpleasant. SP/MC requires a small dose and ensures fluid intake because it is administered in another beverage. Therefore, clinical trials have shown that SP/MC is superior to PEG in terms of acceptability. We aim to compare the novel bowel cleansing method (test group) comprising SP/MC with elobixibat hydrate and the standard bowel cleansing method comprising PEG plus ascorbic acid (standard group) for patients preparing for outpatient colonoscopy. METHODS: This phase III, multicentre, single-blind, noninferiority, randomised, controlled, trial has not yet been completed. Patients aged 40-69 years will be included as participants. Patients with a history of abdominal or pelvic surgery, constipation, inflammatory bowel disease, or severe organ dysfunction will be excluded. The target number of research participants is 540 (standard group, 270 cases; test group, 270 cases). The primary endpoint is the degree of bowel cleansing (Boston Bowel Preparation Scale [BBPS] score ≥ 6). The secondary endpoints are patient acceptability, adverse events, polyp/adenoma detection rate, number of polyps/adenomas detected, degree of bowel cleansing according to the BBPS (BBPS score ≥ 8), degree of bowel cleansing according to the Aronchik scale, and bowel cleansing time. DISCUSSION: This trial aims to develop a "patient-first" colon cleansing regimen without the risk of inadequate bowel preparation by using both elobixibat hydrate and SP/MC. TRIAL REGISTRATION: Japan Registry of Clinical Trials (jRCT; no. s041210067; 9 September 2021; https://jrct.niph.go.jp/ ), protocol version 1.5 (May 1, 2023).

Randomized controlled trial of remimazolam compared with placebo in Japanese patients undergoing upper gastrointestinal endoscopy: Phase III investigator-initiated clinical trial.

OBJECTIVES: To assess the effectiveness of remimazolam against normal saline (placebo) as a sedative agent for endoscopy in a multicenter, randomized, double-blind, investigator-initiated phase III controlled trial. METHODS: We included 48 Japanese patients undergoing upper gastrointestinal endoscopy. For the procedure, an initial remimazolam dose of 3 mg and additional doses of 1 mg were administered, as determined in the phase II clinical study. The primary study end-point was the successful sedation rate during gastrointestinal endoscopy, determined as a Modified Observer's Assessment of Alertness/Sedation score ≤4 before the start of endoscopy, the completion of gastrointestinal endoscopy, and two or fewer additional doses per 6 min. RESULTS: The successful endoscopy sedation rates were 91.9% and 9.1% in the remimazolam and placebo groups, respectively (P < 0.01). The time from the end of endoscopy to arousal was 0.0 (0.0-0.0) min for both groups. The number of additional doses required to achieve sedation was lower in the remimazolam group than that in the placebo group (P < 0.01). CONCLUSIONS: Remimazolam demonstrated a significantly higher sedation effect during upper gastrointestinal endoscopy in Japanese patients with safe and fast recovery compared with placebo.

Comparison of hemostatic ability between spray coagulation and forced coagulation modes in endoscopic submucosal dissection in patients with early gastric neoplasms: a study protocol for multicenter randomized controlled trial (Spray-G trial).

BACKGROUND: Endoscopic submucosal dissection (ESD) is the standard treatment for early gastric neoplasms (EGN). Controlling intraoperative bleeding is crucial for ensuring safe and reliable procedures. ESD using the spray coagulation mode (SCM-ESD) has been developed to control bleeding more effectively than ESD using the conventional forced coagulation mode (FCM-ESD). This study aims to compare the hemostatic efficacies of SCM-ESD and FCM-ESD. METHODS: This multicenter, prospective, parallel, randomized, open-label superiority trial will be conducted in five Japanese institutions. Patients with a preoperative diagnosis of intramucosal EGC will be randomized to undergo either SCM-ESD or FCM-ESD. The primary outcome measure is the completion of ESD with an electrosurgical knife alone, without the use of hemostatic forceps. Secondary outcomes include the number and duration of hemostasis using hemostatic forceps, procedure time, curability, and safety. A total of 130 patients will be enrolled in this study. DISCUSSION: This trial will provide evidence on the hemostatic efficacy of SCM-ESD compared with FCM-ESD in patients with intramucosal EGN, potentially improving the safety and reliability of ESD procedures. TRIAL REGISTRATION: The trial has been registered at the University Hospital Medical Information Network Clinical Trials Registration (UMIN-CTR) as UMIN000040518. The reception number is R000054009.

Impact of an artificial intelligence-aided endoscopic diagnosis system on improving endoscopy quality for trainees in colonoscopy: Prospective, randomized, multicenter study.

OBJECTIVE: This study was performed to evaluate whether the use of CAD EYE (Fujifilm, Tokyo, Japan) for colonoscopy improves colonoscopy quality in gastroenterology trainees. METHODS: The patients in this multicenter randomized controlled trial were divided into Group A (observation using CAD EYE) and Group B (standard observation). Six trainees performed colonoscopies using a back-to-back method in pairs with gastroenterology experts. The primary end-point was the trainees' adenoma detection rate (ADR), and the secondary end-points were the trainees' adenoma miss rate (AMR) and Assessment of Competency in Endoscopy (ACE) tool scores. Each trainee's learning curve was evaluated using a cumulative sum (CUSUM) control chart. RESULTS: We analyzed data for 231 patients (Group A, n = 113; Group B, n = 118). The ADR was not significantly different between the two groups. Group A had a significantly lower AMR (25.6% vs. 38.6%, P = 0.033) and number of missed adenomas per patient (0.5 vs. 0.9, P = 0.004) than Group B. Group A also had significantly higher ACE tool scores for pathology identification (2.26 vs. 2.07, P = 0.030) and interpretation and identification of pathology location (2.18 vs. 2.00, P = 0.038). For the CUSUM learning curve, Group A showed a trend toward a lower number of cases of missed multiple adenomas by the six trainees. CONCLUSION: CAD EYE did not improve ADR but decreased the AMR and improved the ability to accurately locate and identify colorectal adenomas. CAD EYE can be assumed to be beneficial for improving colonoscopy quality in gastroenterology trainees. TRIAL REGISTRATION: University Hospital Medical Information Network Clinical Trials Registry (UMIN000044031).

Left ventricular mass and valve performance after surgical and transcatheter aortic valve replacement: a single-center experience from Japan.

Background: There are few reports on the postoperative left ventricular mass (LVM), aortic valve area (AVA), and pressure gradient (PG) after surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR) in Japan. We aimed to compare the postoperative LVM, AVA, stroke volume (SV), PG, and long-term outcomes between patients undergoing SAVR and TAVR procedures from single center in Japan. Methods: This was a retrospective cohort study. We included 107 patients who underwent simple SAVR between January 2012 and May 2022 (SAVR group, n=107) and 274 who underwent TAVR between January 2016 and May 2022 (TAVR group, n=274). The overall mean follow-up periods was 28.8±25.9 months (median: 24 months; range, 0.03-117 months). Results: The aortic valve mean PG (mmHg) was significantly smaller in the TAVR group than in the SAVR group (P<0.001). The AVA index (cm2/m2) was significantly larger in the TAVR group than in the SAVR group (P<0.001). The SV index (mL/m2) was significantly smaller in the SAVR group than in the TAVR group (P=0.02). The LVM index (LVMI) (g/m2) was significantly smaller in the SAVR group than in the TAVR group (P<0.001). The incidence of mild or higher postoperative paravalvular leak (PVL) and pacemaker implantation were significantly higher in the TAVR group. The 5-year postoperative mortality, re-hospitalization, and major adverse cerebral and cardiovascular events (MACCEs) were significantly better in the SAVR group. Conclusions: The postoperative aortic valve PG, AVA, and SV were better in the TAVR group; however, LVM regression and postoperative outcomes were better in the SAVR group.

Impact of the Barthel Index Score and Prognosis on Patients Undergoing Transcatheter Aortic Valve Replacement and Surgical Aortic Valve Replacement.

BACKGROUND: Few studies have compared the Barthel Index (BI) score and postoperative outcomes of transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR). We aimed to examine the relationship between the BI score and postoperative outcomes in patients who underwent TAVR and SAVR.Methods and Results: The study included patients who underwent SAVR between January 2014 and December 2022 (n=293) and patients who underwent TAVR between January 2016 and December 2022 (n=312). We examined the risk factors for long-term mortality in the 2 groups. The mean (±SD) preoperative BI score was 88.7±18.0 in the TAVR group and 95.8±12.3 in the SAVR group. The home discharge rate was significantly lower in the SAVR than TAVR group. The BI score at discharge was significantly higher in the SAVR than in TAVR group (86.2 vs. 80.2; P<0.001). Significant risk factors for long-term mortality in the TAVR group were sex (P<0.001) and preoperative hemoglobin level (P=0.008), whereas those in the SAVR group were preoperative albumin level (P=0.04) and postoperative BI score (P=0.02). The cut-off point of the postoperative BI score determined by receiver operating characteristic curve analysis was 60.0. CONCLUSIONS: The BI score at discharge was a significant risk factor for long-term mortality in the SAVR group, with a cut-off value of 60.0.

Medical equipment that improve safety and outcomes of inter-facility transportation of critically ill patients: A systematic review.

BACKGROUND: Although many critically ill patients require inter-facility transport for definitive or specialized therapy, the medical equipment required to enhance transport safety remains unclear. This review was performed to summarize the evidence regarding devices used to improve the safety and survival in patients requiring such transport. METHODS: We searched MEDLINE, the Cochrane Central Register of Controlled Trials, and Igaku Chuo Zasshi for randomized controlled trials and observational studies comparing outcomes according to the presence or absence of devices (or new vs conventional devices) during transfer of critically ill patients. RESULTS: Four studies focusing on continuous blood pressure monitoring, extracorporeal membrane oxygenation, pelvic circumferential compression devices, and cuffed tracheal tubes, respectively, met the inclusion criteria. A meta-analysis was not performed because the 4 studies focused on different devices. Near-continuous blood pressure monitoring increased interventions such as intravenous fluid administration during transport, shortened the intensive care unit and hospital lengths of stay, and reduced the incidence of multiple-organ failure compared with use of oscillometric devices. Despite the small sample size and varying severity of illness among the groups, transport of patients with severe respiratory failure under extracorporeal membrane oxygenation resulted in fewer hypoxemic events during transport than transport on conventional ventilators. During transport of patients with pelvic fractures, pelvic belts may help to reduce mortality and the transfusion volume. Cuffed (vs uncuffed) tracheal tubes may reduce post-transport tube replacement events in pediatric patients. CONCLUSION: Studies on devices needed for inter-facility transport of critically ill patients are scarce, but some devices may be beneficial.

Impact of prior bevacizumab therapy on the incidence of ramucirumab-induced proteinuria in colorectal cancer: a multi-institutional cohort study.

BACKGROUND: The association between prior bevacizumab (BEV) therapy and ramucirumab (RAM)-induced proteinuria is not known. We aimed to investigate this association in patients with metastatic colorectal cancer (mCRC). METHODS: mCRC patients who received folinic acid, fluorouracil, and irinotecan (FOLFIRI) plus RAM were divided into with and without prior BEV treatment groups. The cumulative incidence of grade 2-3 proteinuria and rate of RAM discontinuation within 6 months (6M) after RAM initiation were compared between the two groups. RESULTS: We evaluated 245 patients. In the Fine-Gray subdistribution hazard model including prior BEV, age, sex, comorbidities, eGFR, proteinuria ≥ 2 + at baseline, and later line of RAM, prior BEV treatment contributed to proteinuria onset (P < 0.01). A shorter interval between final BEV and initial RAM increased the proteinuria risk; the adjusted odds ratios (95% confidence intervals) for the intervals of < 28 days, 28-55 days, and > 55 days (referring to prior BEV absence) were 2.60 (1.23-5.51), 1.51 (1.01-2.27), and 1.04 (0.76-1.44), respectively. The rate of RAM discontinuation for ≤ 6M due to anti-VEGF toxicities was significantly higher in the prior BEV treatment group compared with that in the no prior BEV treatment group (18% vs. 6%, P = 0.02). Second-line RAM discontinuation for ≤ 6M without progression resulted in shorter overall survival of 132 patients with prior BEV treatment (P < 0.01). CONCLUSION: Sequential FOLFIRI plus RAM after BEV failure, especially within 55 days, may exacerbate proteinuria. Its escalated anti-VEGF toxicity may negatively impact the overall survival.

The effectiveness of corrective exercises on the KOJI AWARENESS score and activity-related pain intensity.

BACKGROUND: The KOJI AWARENESS� screening test is a self-administered screening tool for assessment of mobility, stability, and strength. It provides corrective exercises corresponding to the individual's answers to the KOJI AWARENESS� test questions. However, there is no evidence of the effectiveness of corrective exercises in improving KOJI AWARENESS� screening test scores and activity-related pain. METHODS: Twenty-six healthy subjects (11 female and 15 male ; age 20?50 years) were selected for participation. In a controlled laboratory setting, subjects were administered the KOJI AWARENESS� test and were provided with individualized exercise programs based on the results of this first test. KOJI AWARENESS� results were checked on the first day immediately after the first exercise session, and then again after the two-week program. Pain intensity was also assessed during daily training using a numerical rating scale. RESULTS: Compared to pre-intervention, KOJI AWARENESS� scores were significantly higher immediately after the first corrective exercise session and after 2 weeks of intervention (p<0.001). Moreover, pain intensity was significantly lower after 2 weeks of intervention (p<0.001). CONCLUSIONS: Individualized KOJI AWARENESS� corrective exercises were effective immediately on the first day and also after the two-week program in improving the KOJI AWARENESS� score and reducing pain intensity during daily training. J. Med. Invest. 70 : 208-212, February, 2023.

Association between homologous recombination gene variants and efficacy of oxaliplatin-based chemotherapy in advanced pancreatic cancer: prospective multicenter observational study.

Next-generation sequencing (NGS)-based gene profiling can identify patients with pancreatic cancer with homologous recombinant repair gene pathogenic variants (HRRv). Several retrospective studies have reported a positive association between HRRv and the efficacy of platinum-based chemotherapy. However, this association remains to be validated in a prospective study. This multicenter, prospective, observational study included patients with histologically confirmed unresectable or recurrent pancreatic cancer who required systemic chemotherapy. Patients who were oxaliplatin-naïve patients were eligible. The HRRv status was measured using a College of American Pathologists-accredited NGS panel. One-year overall survival rate (1yr-OS%) was calculated after initiation of oxaliplatin-based chemotherapy and was set as the primary endpoint. Forty patients were enrolled between August 2018 and March 2020. The NGS success rate was 95% (38/40). HRRv was detected in 11 patients (27.5%). Oxaliplatin-based chemotherapy was administered to 9 of 11 patients with HRRv (81.8%) and 15 of 29 patients with non-HRRv (51.7%). The 1yr-OS% after initiation of oxaliplatin-based chemotherapy was 44.4% [95% confidence interval (CI) 13.7-71.9] and 57.1% (95% CI 28.4-78.0) in HRRv-positive and -negative cohorts, respectively. These data suggested that HRRv status alone could not be a potential predictive marker of oxaliplatin-based chemotherapy in patients with advanced pancreatic cancer. These results were in line with the results of a recent phase II study reporting the limited efficacy of poly(adenosine diphosphate-ribose) polymerase inhibitor in patients with pancreatic cancer who harbored HRRv other than BRCA. Future studies investigating patients with biallelic HRRv in the first-line setting are warranted.Trial registration UMIN000033655.

Machine learning-based model for prediction and feature analysis of recurrence in pancreatic neuroendocrine tumors G1/G2.

BACKGROUND: Pancreatic neuroendocrine neoplasms (PanNENs) are a heterogeneous group of tumors. Although the prognosis of resected PanNENs is generally considered to be good, a relatively high recurrence rate has been reported. Given the scarcity of large-scale reports about PanNEN recurrence due to their rarity, we aimed to identify the predictors for recurrence in patients with resected PanNENs to improve prognosis. METHODS: We established a multicenter database of 573 patients with PanNENs, who underwent resection between January 1987 and July 2020 at 22 Japanese centers, mainly in the Kyushu region. We evaluated the clinical characteristics of 371 patients with localized non-functioning pancreatic neuroendocrine tumors (G1/G2). We also constructed a machine learning-based prediction model to analyze the important features to determine recurrence. RESULTS: Fifty-two patients experienced recurrence (14.0%) during the follow-up period, with the median time of recurrence being 33.7 months. The random survival forest (RSF) model showed better predictive performance than the Cox proportional hazards regression model in terms of the Harrell's C-index (0.841 vs. 0.820). The Ki-67 index, residual tumor, WHO grade, tumor size, and lymph node metastasis were the top five predictors in the RSF model; tumor size above 20 mm was the watershed with increased recurrence probability, whereas the 5-year disease-free survival rate decreased linearly as the Ki-67 index increased. CONCLUSIONS: Our study revealed the characteristics of resected PanNENs in real-world clinical practice. Machine learning techniques can be powerful analytical tools that provide new insights into the relationship between the Ki-67 index or tumor size and recurrence.

[Surgical Outcomes Prior to Antibiotics Administration for Infective Endocarditis].

OBJECT: We examined the surgical outcomes for infective endocarditis (IE) at our institution. METHODS: Between January 2012 and March 2022, we operated on 43 patients who diagnosed active IE. We decided to perform surgery after antibiotics administration for at least two weeks. RESULTS: The mean age was 63.9 years old, and 28 male were included. The affected valves were 12 aortic valves, and 26 mitral valved and five multi valves, the causative microorganisms were Staphylococcus aureus 14 patient, Staphylococcus spp. 3 patients, Streptococcus spp. 17 patients, Enterococcus spp. 3 patients, and others 6 patients. One patient underwent aortic valve repair, and 17 patients underwent aortic valve preplacement. Twenty four underwent mitral valve repair, and eight underwent mitral valve replacement. The duration of preoperative antibiotics administration was 27.7±2.1 days (median 28 days). There were six in-hospital death (motality 14.0%). The five-years survival rate was 78.1% and the freedom from cardiac events at five years was 88.4%. CONCLUSION: The strategy for preoperative management and timing of surgery for IE patients at our institution was appropriate.

Surgically-treated hemoptysis and alveolar hemorrhaging resulting from severe mitral regurgitation: A case report.

Cardiac etiologies of hemoptysis are less common. One such etiology includes mitral regurgitation. In patients with hemoptysis and unilateral consolidation, careful chest auscultation and cardiac assessment may assist in making an early diagnosis.

Feasibility, Safety, Enjoyment, and System Usability of Web-Based Aerobic Dance Exercise Program in Older Adults: Single-Arm Pilot Study.

BACKGROUND: During the COVID-19 epidemic, opportunities for social interaction and physical activity among older people are decreasing, which may have a negative impact on their health. As a solution, a web-based group exercise program provided through a videoconferencing platform would be useful. As a web-based exercise program that older adults can easily, safely, and enjoyably perform at home, we developed a short-duration, light-intensity aerobic dance exercise program. Before studying the effectiveness of this exercise program, its characteristics, such as feasibility, safety, enjoyment, and system usability, should be examined among older adults. OBJECTIVE: This pilot study aimed to examine the feasibility, safety, and enjoyment of a web-based aerobic dance exercise program and the usability of a web-based exercise delivery system using a videoconferencing platform for older adults. METHODS: This study was designed as a prospective single-arm pilot study. A total of 16 older adults participated in an 8-week web-based aerobic dance program held every morning (8:30 AM to 8:50 AM) on weekdays at home. Retention and adherence rates were measured for the program's feasibility. Safety was assessed by the heart rate reserve, an index of exercise intensity calculated from heart rate, and the number of adverse events during exercise sessions. Enjoyment of this exercise program was assessed by an 11-point Likert scale ranging from 0 (not enjoyable at all) to 10 (extremely enjoyable) obtained through telephone interviews after the first-, third-, sixth-, and eighth-week intervention. For usability, the ease of the videoconferencing platform system was assessed through telephone interviews after the intervention. RESULTS: A female participant with hypertension dropped out in the second week because of the continuously reported high blood pressure (≥180 mmHg) before attending the exercise session in the first week. Therefore, the retention rate was 93.8% (15/16). Among the remaining participants, the median (IQR) overall adherence rate was 97.4% (94.7-100). Regarding safety, the mean (SD) heart rate reserve during the aerobic dance exercise was 29.8% (6.8%), showing that the exercise was relatively safe with very light to light intensity. There were no adverse events during the exercise session. The enjoyment score (0-10 points) significantly increased from the first (6.7 [1.7]) to sixth (8.2 [1.3]) and eighth week (8.5 [1.3]). Regarding usability, 11 participants reported difficulties at the beginning, such as basic touch panel operations and the use of unfamiliar applications; however, all got accustomed to it and subsequently reported no difficulty. CONCLUSIONS: This study showed high feasibility, enjoyment, and safety of the web-based aerobic dance exercise program in older adults, and the web-based exercise delivery system may have areas for improvement, albeit without serious problems. Our web-based aerobic dance exercise program may contribute to an increase in physical and social activities among older adults.

Safety and Efficacy of Sedation During Emergency Endoscopy for Upper Gastrointestinal Bleeding: A Propensity Score Matching Analysis.

BACKGROUND AND AIM: This study aimed to compare patients with and without sedation during emergency endoscopy for upper gastrointestinal bleeding (UGIB) and to clarify the safety and efficacy of sedation in emergency endoscopy. METHODS: We retrospectively collected 389 patients who underwent emergency endoscopy for UGIB at Ureshino Medical Center from 2016 to 2021. Patients were divided into two groups: sedation group during emergency endoscopy and nonsedation group. Clinical characteristics, patient status on admission, and UGIB etiology were evaluated. Treatment outcomes and adverse events were evaluated using propensity score matching (PSM), and risk factors for mortality from UGIB were investigated using Cox multivariate analysis. RESULTS: The sedation group was significantly younger, composed of a higher proportion of males, and had chronic liver disease. Blood pressure and hemoglobin level on admission were significantly higher in the sedation group. The main cause of bleeding was peptic ulcer, which was significantly higher in the nonsedation group. PSM created 133 matched pairs. The success rate of endoscopic hemostasis was similar in both groups, and procedure time was significantly shorter in the sedation group than in the nonsedation group (17.6 ± 10.0 versus 20.2 ± 10.2 min, P = 0.04). There were no significant differences in adverse events between groups. Cox multivariate analyses revealed that red blood cell transfusion [hazard ratio (HR) 4.45, P < 0.02] and rebleeding (HR 3.30, P = 0.03) were associated with increased risk of 30-day mortality from UGIB. CONCLUSIONS: Sedation reduced the procedure time during emergency endoscopy for UGIB. Sedation during emergency endoscopy for UGIB is acceptable for safe endoscopic procedures.

Efficacy and safety of vonoprazan-based regimen for Helicobacter pylori eradication therapy in Japanese adolescents: a prospective multicenter study.

BACKGROUND: Vonoprazan (VPZ)-based regimen for Helicobacter pylori (H. pylori) is safe and more efficacious than the proton pump inhibitor-based regimen mainly in adults. This study aimed to evaluate the efficacy and safety of a VPZ-based regimen for H. pylori eradication therapy in adolescents. METHODS: An H. pylori screening and treatment longitudinal project for third-year junior high school students in Saga Prefecture began in 2016. Students who tested positive for both urine and stool tests received a VPZ-based regimen. On the checklist, students were asked for diarrhea, fever, abdominal pain, nausea, vomiting, urticaria, dysgeusia, or bloody stool occurrence during the therapy. RESULTS: The longitudinal project for H. pylori screening and treatment among third-grade students in Saga Prefecture targeted 41,115 students from 2017 to 2021 and 836 as positive. Of the 645 students, 542 (84.0% in per protocol [PP] analysis and 73.6% in intention-to-treat [ITT] analysis) were successful in primary eradication therapy. The secondary eradication therapy was successful in 79 (96.3% in PP analysis and 76.7% in ITT analysis) of 82 students. In the primary eradication therapy, abdominal pain occurred in 164 (27.9%), diarrhea in 217 (36.9%), nausea or vomiting in 7 (1.2%), and urticaria in 13 (2.2%) students. In the secondary eradication therapy, abdominal pain occurred in 12 (19.4%) and diarrhea in 17 (27.4%) students. The eradication therapy of 5 students was interrupted due to adverse events only by primary eradication therapy. CONCLUSIONS: VPZ-based regimen for H. pylori was efficacious and safe for adolescents, as in adults, for both primary and secondary eradication therapies.

Validity of the KOJI AWARENESS self-screening test for body movement and comparison with functional movement screening.

OBJECTIVE: This study aimed to validate the KOJI AWARENESS™, a self-screening movement test, and compare it with the Functional Movement Screen (FMS). METHODS: Fifty-seven healthy participants completed the KOJI AWARENESS™ and functional movement screening. Pearson's correlation coefficients were used to assess the validity of the test. Subsequently, partial correlation analysis was used to determine the associations between age, sex, body mass index, and sports level as control variables and motor function. RESULTS: Correlation and partial correlation analyses showed a strong positive correlation between the functional movement screening and the KOJI AWARENESS™ scores. CONCLUSION: This study found that the KOJI AWARENESS™ test is valid and comparable to functional movement screening. It can be used for self-screening of movement.

Further Evidence that Gradients of Extracellular pH Direct Migration of MDA-MB-231 Cells In Vitro.

We hypothesised that concentration gradients of O2/H+ within tissue guide migration of primary cancer cells toward intra-tumour microvessels, thus promoting intravasation and eventual haematogenous metastasis of cancer cells. Previously, we demonstrated in vitro that MDA-MB-231 cells under pH and O2 gradients (0.2-0.3 units/mm and ~ 6%/mm, respectively) migrate toward higher pH/O2 regions. The present study was designed to address questions yet unanswered in the previous one, i.e., (1) whether extracellular O2 gradients could be a cue for directional cell migration in physiologically relevant O2 environments, and (2) whether average pH level in the bulk extracellular medium affects directional cell migration. In the absence of pH gradients, directional cell migration was not demonstrated at a physiological O2 level (<5%). We demonstrated that both the migration velocity and directionality are significantly affected by the average extracellular pH level. This result is consistent with our model for directional cell migration that does not necessitate sensing of pH gradient at a single cell level. Thus, in this study, we demonstrated further evidence that gradients of extracellular pH direct migration of MDA-MB-231 cells in vitro.