Endoscopic retrograde cholangiopancreatography (ERCP) is one of the most frequently performed minimally invasive procedures currently available for diagnosis and treatment of biliary and pancreatic diseases. Though considered a safe procedure, it has the highest rate of complications among the other endoscopic procedures, such as duodenal perforation and hepatic subcapsular hematoma (HSH). We are a presenting a case report and review of the current literature.We report one case HSH rupture, in a 25 years old female patient, 15 cm in diameter, affecting liver segments VI, VII and VIII, who underwent surgical treatment and performed a systematic literature review with the descriptors: endoscopic retrograde colangiopancreatography and hepatic subcapsular hematoma. All articles were reviewed and data on cases that presented rupture of the HSH analyzed separately.Sixty one cases of HSH were described in the literature, fourteen of them ruptured.When analyzing only the subgroup of patients who had ruptured subcapsular hematoma, we showed a significant increase in the mortality rate of patients when compared to non-ruptured (21.4% × 2.2%). We also report that patients with rupture required some type of intervention, of which 78.6% required surgery.Conservative treatment may be the conduct and will suffice for most cases of non-ruptured hematomas. For patients who evolve with rupturing, surgical resolution, although non-mandatory, is necessary in most cases.HSH ruptured is a rare and potentially fatal post-ERCP complication whose treatment is eminently surgical. Although it is a safe method, ERCP has the highest incidence of complications among upper gastrointestinal endoscopic procedures ,2, with Complications routinely described include acute pancreatitis (most common), acute cholangitis, hemorrhage, sepsis and cardiopulmonary changes . HoweverRegarding HSH, a extraluminal hemorrhagic complication with potential morbidity and mortality, there are 53 reports in literature, with a combined mortality rate of 7.5%, being 10 of those ruptured. The aim of this study is to perform a systematic review of HSH, an uncommon and high morbidity complication, and to report the case of a patient who presented with HSH after ERCP for choledocholithiasis treatment. The work has been reported in line with de SCARE criteria , and is 2A literature review was performed with the following descriptors: endoscopic retrograde cholangiopancreatography and hepatic subcapsular hematoma, in the following datebase: PubMed, scopus, BIREME.Exclusion criteria was: articles that did not have at least an abstract available in one of the following languages: Italian, French, English and Portuguese. All articles were reviewed and data on cases with HSH rupture were analyzed separately.The data was collected by two different authors, individually, and then analyzed, in case of any disagreement another author reviewed the original paper to minimize any error.Of the initial 70 results, nine were excluded due to not being related to the research, 2 were excluded due to language and finally 5 were excluded due to not have at least an abstract available .Chart 1F3A 25-year-old female teacher, married, native to Argentina, with no comorbidities, BMI of 24, was admitted to with jaundice to the emergency department (Bilirubin 11.2 mg/dL), with secondary choledocholithiasis diagnosed by ultrasound (US) imaging. Abdominal US showed a normal-looking liver, dilated intra and extrahepatic biliary system, with 1.3 cm bile duct and 1.0 cm calculus inside, and ERCP was indicated for treatment. The procedure was successful, and calculus was removed with the help of guide wire and papillotomy, without complications. The gallbladder did not contrast during the exam.The patient returned to the ward hemodynamically stable and asymptomatic. After 8 h of ERCP, she experienced sudden abdominal pain and pallor, laboratory tests and abdominal radiography showed significant gastric distension  and raisAntibiotic therapy was initiated with ciprofloxacin 400 mg every 12 h and metronidazole 500 mg every 8 h, and a CT scan of the abdomen was performed and showed subcapsular hematoma of about 15 cm in diameter, affecting liver segments VI, VII and VIII, with air and a small amount of perihepatic free fluid . At thisIntraoperatively, a minimal amount of hemoperitoneum, a gallbladder with thick and delaminated walls, and subcapsular hematoma affecting the right lobe of the liver with oozing bleeding in segment VI were identified . PatientOn the fourth postoperative day (PO), she evolved with hemodynamic instability and 1500 mL of bloody outflow through the drain, and a new surgical approach was indicated. During the intraoperative period, moderate hemoperitoneum, subcapsular hematoma affecting the entire enlarged hepatic parenchyma, and hepatic bleeding in a laceration pattern were observed. Patient received 05 units of packed red blood cells and was submitted to argon-based hemostasis and tamponade with six compresses.She remained intubated with ARDS (acute respiratory distress syndrome), maintaining a PaO2/Fio2 ratio of 60. Abdominal drainage was serosanguineous with an outflow rate of around 40 mL. After ventilatory improvement, a new laparotomy was performed, and compresses were removed. The liver was bruised on its entire surface, with no active bleeding, and enlarged . She was extubated on the 13th postoperative day and was discharged from the Intensive Care Unit (ICU) the following day, using antibiotics and pharmacologic venous thromboembolism prophylaxis.In the ward, the patient had some isolated fever peaks, with no defined source, and maintained antibiotic therapy with ciprofloxacin and metronidazole. On the 20th postoperative day, the patient was asymptomatic, with normal leukogram and sustained hemoglobin levels . She und4ERCP is an endoscopic procedure commonly performed since its introduction in 1968  with estThe overall mortality rate of this procedure after diagnostic intervention is 0.2%  and afteHepatic subcapsular hematoma is an extraluminal hemorrhagic complication secondary to ERCP, whose pathology is poorly understood and potentially life-threatening, requiring early identification and treatment. HSH after ERCP is a rare complication, but may be more frequent than previously thought ,26. So fThe incidence of this complication may be underestimated, since most patients have no symptoms and post-ERCP monitoring is uncommon ,28. The The etiology of these hematomas is still unclear, and two hypotheses have been raised. The first one suggests that liver damage is secondary to the traction force exerted by the biliary duct extractor balloon when trying to remove a retained calculus. This force would cause the rupture of biliary vessels and branches, with subsequent bleeding ,30. The In the literature review conducted in this study, of the 61 cases analyzed, 49 reported the use of guidewire in the procedure (80.3%), while 12 of them made no mention of its use or not (19.7%).Clinical manifestations of HSH are varied, including abdominal pain, shoulder pain, anemia, fever, and signs of hypotension. The literature review of this study showed that the most frequent clinical manifestation is abdominal pain (82.0%) followed by anemia (55.7%), hypotension (27.9%), fever (18.0%), and shoulder pain (13.1%)  which coThe onset of these symptoms, associated with subsequent or immediate hypotension, is suggestive of the presence of HSH. Their manifestation may occur from hours to days after the procedure ,37. Our When analyzing the time of onset the HSH rupture cases shows a significant reduction in the median time 12 h (1–96 h) compared to 27 h (2 h – 15 days) in the HSH and average time, as in the average time 25.5 h HSH rupture group and 69,4 h HSH .Table 3HThe most predominant diagnostic methods for HSH are CT (91.4%) and US (22.4%). In the reported case, the patient experienced abdominal pain, the most frequently described symptom, and anemia 8 h after ERCP, with abdominal CT.By analyzing only the subgroup of patients who had HSH rupture, we detected a significant increase in the mortality rate compared to non-ruptured (21.4% × 2.2%), even though the rupture subgroup was only 23.7% of the total number of cases reported in the literature. We also detected that patients with rupture required some type of intervention, of which 78.6% required surgery .The is a predominance HSH in right the lobe (87.3%) with 5.5% of the cases affecting both lobes; we also perform a statistic analyze, using Fisher's exact test, and no associations between death and the affected liver lobe side (p = 0.256) were verified.Treatment should be customized on a case-by-case basis, but antibiotic therapy is always recommended due to the high risk of infection ,26. HemoIn addition, monitoring hematoma progression with imaging such as CT and US is the optimal approach. Whenever there is hemodynamic instability with active bleeding and contrast extravasation, immediate surgical or radiological approach should be considered .Surgical treatment should be considered when patient’s general conditions becomes deteriorated, when there is hemodynamic instability, signs of peritoneal irritation, infected hematoma, findings of abdominal free fluid on CT  and compShould active bleeding and hemodynamic instability insue, it is reported in the literature that arteriography with bleeding source embolization has been used to control bleeding with satisfactory results ,26,28,30A review of the literature revealed the predominance of conservative treatment (39.3%), followed by surgical approach (27.9%), percutaneous hematoma drainage (22.95%), and, finally, embolization treatment (8.2%) .Table 4T5Hepatic subcapsular hematoma is a potentially fatal post-ERCP complication and should be considered as differential diagnosis of symptomatic post-procedure cases.No conflicts of interest relevant to this article.At our own expenses.0897129.0.0000.5479.Ethics approval: Santa Casa de São Paulo Ethics and Research Committee in Reference number: Written informed consent was not obtained from the patient. The head of our medical team has taken responsibility that exhaustive attempts have been made to contact the family and that the paper has been sufficiently anonymised not to cause harm to the patient or their family. A copy of a signed document stating this is available for review by the Editor-in-Chief of this journal on request.Luca G A Pivetta, conceptualization, Validation, Writing - Original Draft ; Caroline P C Ferreira, Methodology, Validation ; João P V Carvalho, Formal analysis, Data Curation ; Renata Y L Konichi, Data Curation, Software, Writing - Review & Editing,; Victor K F Kawamoto, Data Curation, Software ; Jose C Assef, Writing - Review & Editing, Supervision ; Mauricio A Ribeiro, Methodology, Writing - Review & Editing, Supervision, Project administration.Case reports that are not first-in-man study already approved in Ethics Committee.Pivetta, L.G.A.Not commissioned, externally peer-reviewed.


A non-hierarchical cluster analysis was conducted to evaluate the essential gait ability, according to the results of the PC1 score. One-way repeated analysis of variance with the Bonferroni correction was used to compare gait performances in the cluster groups. PCA outcomes indicated 76.9% variance for PC1–PC6, where PC1 (gait variability (GV): 18.5%), PC2 (pace: 17.8%), PC3 (rhythm and phase: 13.9%), and PC4  were the gait-related factors. All of the pace, rhythm, GV, and variables for bilateral coordination classified the gait ability in the cluster groups. We suggest that the treadmill walking task may be reliable to evaluate the gait performances, which may provide insight into understanding the decline of gait ability. The presented results are considered meaningful for understanding the gait patterns of healthy adults and may prove useful as reference outcomes for future gait analyses.This study investigated the gait characteristics of healthy young adults using shoe-type inertial measurement units (IMU) during treadmill walking. A total of 1478 participants were tested. Principal component analyses (PCA) were conducted to determine which principal components (PC Gait analysis is used to evaluate the physical function, health status, and quality of life ,2. It isSeveral gait analysis studies have been conducted in children , young aBy contrast, walking on treadmills may be more useful for the collection of data pertaining to numerous continuous walking steps in comparison with methods involving repeated and averaged patterns due to decreased space requirements, multiple repetitions of strides, and controllability of the walking speed . RecentlIn addition, utilizing a shoe-type inertial measurement unit (IMU) system has advantages when compared with previous studies using IMU sensors. The IMU sensors are mounted on both the left and right outsoles, which may enhance their position stability as well as decrease the motion artifacts and dynamic acceleration in comparison with the case where the IMU sensor is placed on the lumbar vertebra ,28, lates) such as the spatiotemporal parameters , GV, and the variables for bilateral coordination in all the participants as well as male and female. Lastly, the third purpose was to determine the characteristics of gait performance based on the clustered groups, according to the results of the PC1 score. Thus, we classified the clustered groups to determine the respective gait characteristics of young adults. We hypothesized that the participants who had altered gait variables indicated poorer gait performance based on the gait-related variables than the other participants.Therefore, the purpose of this study was the investigation of the gait characteristics in healthy young adults using shoe-type IMU during treadmill walking . The primary purpose was to examine which variables best defined the characteristics of healthy young adults with principal component analysis (PCA). The secondary purpose was to establish the normative reference values for the principal components . None of the participants had any history of musculoskeletal or neurological problems that affected gait, and all participants were able to walk without any support. Thirty-six participants were excluded from the study because they did not complete the testing for personal reasons. In total, 1478 participants  successfully performed the treadmill walking test (response rate: 92.4%) . All theTM, JEIOS, South Korea), which consisted of shoe-type data loggers  and a data acquisition system, were utilized in this study. The shoe-type data logger included an IMU sensor  that could measure triaxial acceleration (up to ± 6 g) and tri-axial angular velocities (up to ± 500° s−1) along the three orthogonal axes [®. The shoe-type IMU system showed excellent data agreement of the spatiotemporal parameters when compared with a three-dimensional motion capture system for healthy adults and patients with Parkinson’s disease  [Shoe-type IMU systems  ,33. The Prior to the treadmill walking test, biometric data were recorded for all the participants, including body height, weight, and body fat percentage. All participants completed questionnaires to assess their responses to physical activity (PA). PAs were evaluated with the use of the international PA questionnaire–short form (IPAQ–SF), which was composed of seven items that pertained to the self-reported PA of the participants, such as high, moderate, and walking PA. Based on these questionnaires, we assessed the frequency (days/week) and calculated the metabolic equivalents /week) . All the participants performed over-ground walking tests in a straight 10 m walkway before the treadmill test to calculate their self-preferred walking speeds  . SubsequThe treadmill walking data were collected at 100 Hz and were filtered with a second-order Butterworth low-pass filter with a cut-off frequency of 10 Hz ,32,33. LSpatiotemporal parameters were calculated as follows: 1) Pace: walking speed, stride length, step length, and normalized variables, 2) Rhythm: cadence, and 3) Phases: single support, double support, and stance. Similar to the case of the GV, the percentage coefficient of variance (CV) values were also calculated for all the spatiotemporal parameters ((standard deviation/mean) × 100) ,37. To evaluate the bilateral coordination, we calculated the gait asymmetry (GA) and phase coordination index (PCI) based on a previous study . The GA The PCI value integrates the accuracy and consistency of the left–right movements during over-ground walking. In order to calculate the PCI value, we first calculated the mean of the swing time for the left and right legs, and the higher value of the average swing time was used as the reference for the opposing leg . The relLi and tSi represent the times of the ith HS of the legs for long and short swing times, respectively, where tL(I + 1) > tSi > tLi. In order to maintain symmetry during walking, the φi value should be approximately 180°. Therefore, the mean value of the series of absolute differences (ABS) between φi and 180° (ABS_φ) was calculated to evaluate the overall accuracy. Furthermore, we also calculated the CV of φ in order to assess the level of consistency during the over-ground walking test. The PCI value was calculated as the combined CV of φ and percentage of ABS_φ (ABS_φ/180 × 100) [In this case, ts that had eigenvalues that exceeded unity were retained for interpretation. In addition, the Pearson’s product moment correlation analysis was used to determine the relationships between the PCs and the PAs.All the statistical analyses were performed using a commercially available statistics software program for Windows . The Shapiro–Wilk test was used to determine whether the data were normally distributed. To examine which variables best defined the characteristics of healthy young adults, we used PCA with a varimax rotation. Prior to PCA, Z-normalization  was performed for all the tested variables. The PC1 score. Prior to the non-hierarchical cluster analyses, hierarchical cluster analysis was conducted to determine the optimal number of clusters by means of a dendrogram [1 score. One-way analysis of variance (ANOVA) with the Bonferroni correction was used to compare the differences among the cluster groups (top vs. middle vs. lowest) with respect to the pace, rhythm, phases, GV, and variables for the bilateral coordination. The statistical significance level for the post-hoc test was set to 0.0167 (0.05/3).To establish the normative values for the gait-related variables, which includes mean and standard deviation as well as 95% of the confidence interval (CI), were also described for all participants. In addition, determining the gait characteristics for the healthy young adults, we conducted non-hierarchical cluster analyses (k-means method) to evaluate the essential gait ability according to the outcomes of the PCndrogram , where ts indicated as a result of PCA, and PC1 to PC6 explained 76.9% of the total variance (s are interpreted as follows: 1) PC1 refers to the GV, which is composed of the CVs of the spatiotemporal parameters and φ, 2) PC2 refers to the pace parameters, and comprises the walking speed, stride, step length, and normalized variables, 3) PC3 refers to the phases and rhythm, and comprises the single support, double support, and stance phases, and cadence, 4) PC4 refers to the variables for bilateral coordination and GA, 5) PC5 refers to the demographic characteristics, and 6) PC6 refers to the PAs. The results of the factor loadings for the PCs are listed in s and the total PAs indicated that PC1 exhibited a negative trend , whereas PC2 exhibited a positive trend  with respect to the frequency of the total PA.A total of six PCvariance . The PCsWe established the normative values for the pace, rhythm, phases, GV, and variables for the bilateral coordination in 1 score, which is the GV. There were no significant differences among the cluster groups 1 to 3. We clustered group according to the PCs were 76.9% (PC1 to PC6), whereas PC1 (GV: 18.5%), PC2 (pace parameters: 17.8%), PC3 (phases and rhythm parameters: 13.9%), and PC4  were gait-related variables. 2) We established the normative values for both all participants and males and females. 3) All of the pace, rhythm, GV, and variables for bilateral coordination clearly classified the gait ability in the cluster groups. These findings are discussed in detail below.The main findings of this study are as follows. 1) The contributions of the PC1 to PC6 explained 76.9% of the observed variances. Our reported PC1 was the GV parameter, which explained 18.5% of the observed variables. It was composed of the GV for the pace and phase parameters, and the CV of φ among the PCI variables. In addition, PC2 was the pace parameter, which was composed of the stride length, step length, walking speed, and other normalized variables, and explained 17.8% of the observed variables. These variables have been used as the primary parameters of gait analyses [1 (GV) and PC2 (Pace parameters) were related to the frequency of the PAs. In the cases where the participants performed PAs on a regular basis, their gait performances and postural stabilities were likely enhanced. In turn, this may indicate increased walking speeds or step lengths and decreased GV. Therefore, we propose the utilization of the GV and pace parameters to evaluate the gait ability.Our study conducted PCA analyses in healthy young adults in which the PCs best defined their gait characteristics. These results indicated that PCanalyses ,4,5,6. Tanalyses . Diminisanalyses  due to aanalyses , which manalyses . As indianalyses ,43,44,45analyses ,47, whicIn addition, our GV in the young adults indicated the stride length: 1.72% to 1.89%, step length: 1.01% to 1.09%, single support phase: 3.30% to 3.59%, double support phase: 7.24% to 7.62%, and stance phase: 2.55% to 2.72%. These results may be useful as the normative reference values because most previous studies focused on elderly adults ranging from 70 to 89 years old. Accordingly, these studies acknowledged that there was a lack of reference values for GV for young and middle-aged adults [Furthermore, our results indicated the GA and PCI values ranged between 1.72%–1.78% and 3.23%–3.48%, respectively. Our reported values for the GA and PCI exhibited narrow ranges when compared to previous studies ,11,12. IWe clustered the group according to the PC1 score, which is the GV. The pace, rhythm, GV, and variables for bilateral coordination classified the gait performance in the cluster groups. Specifically, cluster group 1 (top level) yielded faster walking speed and larger stride length compared to cluster groups 2 (middle level) and 3 (lowest level). We determined that the gait performance trends were worse for cluster group 3. Our participants who had shortened stride lengths and longer stance phases yielded slower walking speeds and larger GV, GA, and bilateral coordination. Increased walking speeds resulted in increases in the single support phase, whereas decreased walking speeds resulted in increases of the double support and stance phases . The sloIn addition, cluster group 3 (lowest level) yielded similar GV and PCI ranges compared with the healthy elderly population evaluated in previous studies  ,49. IncrThere are several strengths associated with this study. First, we analyzed relatively large samples of healthy young adults and determined the gait characteristics using various methods that included establishing reference values, which is compared to the gait performances. Second, our gait-related variables are considered reliable. For instance, our results for the GA and PCI exhibited relatively narrow ranges compared to previous studies ,11,12. TWe also recognize the limitations associated with this study. First, we recruited participants with prior experience in using the treadmill. The participants were asked to walk naturally on the treadmill, as in daily life, to the greatest extent possible during the testing procedure. Some previous studies have reported no significant differences in the spatiotemporal parameters between treadmill walking and over-ground walking in healthy humans ,50,51,52Our study investigated the gait characteristics in healthy young adults ranging in age from 19 to 30 years old using shoe-type inertial measurement units (IMU) during treadmill walking . We determined the characteristics of healthy young adults using PCA. It may be meaningful to utilize the pace, rhythm, and phase parameters as well as the GV values to evaluate the gait performance. In addition, we established the normative values of both all participants and males and females. Lastly, the pace, rhythm, GV, and variables for bilateral coordination classified the gait ability in young adults. Specifically, the participants who attained shortened stride lengths and longer stance phases yielded worse GV and bilateral coordination outcomes and needed to enroll in interventional programs to enhance their motor functions and reduce the potential risk that would lead to the decline of their gait abilities. Therefore, we consider that our results are meaningful and aid the understanding of gait patterns in healthy adults. We consider that they could be proven useful as reference values for assessing gait analyses in the future.


Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is an innovative approach for treating peritoneal carcinomatosis that applies chemotherapeutic drugs into the peritoneal cavity as an under-pressure airflow. It improves local bioavailability of cytostatic drugs as compared to conventional intraperitoneal chemotherapy. The aim of this study is to prove feasibility, efficacy and safety of this new treatment. Patients included in the analysis underwent at least two single port PIPAC procedures; drugs used were Oxaliplatin for colorectal cancers and Cisplatin + Doxorubicin for ovarian, gastric, and primary peritoneal cancers. The primary endpoint was the Disease Control Rate according to the RECIST  criteria. Secondary significant endpoints were overall and progression free survival, tumor regression on histology, and quality of life. Safety and tolerability were assessed according to the Common Terminology Criteria for Adverse Events 4. Sixty-three patients were enrolled in this trial. Forty patients (100 PIPAC) were eligible for analysis. Twenty patients were undergoing systemic chemotherapy. Fourteen patients reported an objective response (35%). Median overall survival was 18.1 months; median progression-free survival was 7.4 months. Minor morbidity was observed in seven procedures. Grade 3 complications occurred in two patients, and grade 4 in one patient submitted to reoperation. Single-port PIPAC is feasible, safe, and easy to perform. The combined treatment based on systemic chemotherapy and PIPAC does not induce significant hepatic and renal toxicity and can be considered a valid therapeutic option in patients with advanced peritoneal disease. Further studies on the use of PIPAC alone, possibly with different drug dosages, may define the real effectiveness of the procedure. Peritoneal carcinomatosis (PC) is a common manifestation of advanced gynecological and gastrointestinal malignancies, still associated to bad prognosis in the absence of an aggressive multimodal therapy. Although the combined treatment of cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) has been increasingly proposed as a curative treatment, the therapy of peritoneal metastasis remains largely palliative.CRS and HIPEC represent the gold standard treatment for pseudomyxoma peritonei (PMP) ,2 and peFor non-resectable PC, palliative systemic chemotherapy (sCT) is still, nowadays, often the standard of care. Some cheering improvement in survival was recorded in PC from colonic cancer, in which median survival raised from six to 24 months by novel drug agents . In othePressurized intraperitoneal aerosol chemotherapy (PIPAC) is an innovative intraperitoneal chemotherapy approach for peritoneal carcinomatosis that could overcome the limitation of IPC  . This neOn the basis of these considerations, we tested PIPAC within the framework of a single center, open label, non-randomized, single-arm, repeated single dose study to explore the efficacy, safety, and DCR (Disease Control Rate) of cisplatin, oxaliplatin, and doxorubicin in patients with PC from ovarian, gastric, and colorectal cancers and in primary cancers of the peritoneum.The target subject population is composed of patients with ovarian and colorectal cancers reporting relapse, or disease progression with peritoneal carcinomatosis after at least two lines of previous IV standard chemotherapy; and patients with recurrent gastric cancer, PMP, and primary peritoneal tumors, reporting disease relapse or progression with peritoneal carcinomatosis, after at least one line of previous IV standard chemotherapy. Patients had to be ineligible for cytoreductive surgery +/- HIPEC, and not tolerate or refuse systemic chemotherapy.Specifically, patients were eligible if they had clinical and pathological confirmation of peritoneal carcinomatosis from gastric, colorectal, and ovarian cancers or primary peritoneal tumors; were aged between 18 and 78 years; had good performance status (ECOG ≤ 2), blood and electrolytic counts, and liver, renal, and cardiopulmonary function parameters within 10% of the normal range; and a tumor mass present on CT-scan, in order to allow tumor response assessment with RECIST-criteria. All patients signed an informed consent form.Any of the following are regarded as an exclusion criterion from the study: extra-abdominal metastatic disease, with the exception of isolated pleural carcinomatosis; bowel obstruction; severe renal impairment; myelosuppression; severe hepatic impairment; severe myocardial insufficiency; recent myocardial infarction; severe arrhythmias; immunocompromised patients; or pregnancy. Progressive ascites was not an exclusion criterion.The PI-CaP study was approved by the Italian drug agency  and Istituto Superiore di Sanità. The study was registered with ClinicalTrials.gov, number NCT02604784 and EudraCT number 2015-000866-72 (approved on 30 April 2015). 18F-FDG PET according to PERCIST (Positron Emission Tomography Response Criteria in Solid Tumors) criteria (version 1.1); overall survival (OS); progression-free survival (PFS) according to RECIST criteria (version 1.1) after two or three cycles of PIPAC; degree of histological regression assessed by pathological review; and evaluation of specific circulating tumor markers before and after the first, second, and third PIPAC.The primary endpoint of the study was the DCR according to RECIST criteria (version 1.1) after two cycles of PIPAC. DCR was defined as the total number of patients with complete radiological response, partial response, and stable disease. A baseline abdominal CT scan was required ≤4 weeks before the first PIPAC procedure and repeated after the second PIPAC cycle. A further CT scan was not performed, in the case of clinical progressive disease. Secondary outcomes were the clinical tumor response to therapy, using Quality of life was evaluated according to the Short Form 36 Health Survey (SF-36), before the beginning of the treatment and after each PIPAC procedure.Safety and tolerability were assessed by the collection of adverse events, according to the Common Terminology Criteria for Adverse Events (CTCAE) 4, including physical examination results and laboratory assessments (chemistry and hematology).The survival follow-up data were regularly updated by medical examination or telephone calls. The last patient’s last visit (the study required at least 1-year follow-up after the second/third PIPAC procedure) was 30 October 2018. Clinical, laboratory and histopathology data were documented in our hospital information system and reported in a paper clinical record form. The histopathological response (regression grading) was assessed according to the PRGS . The patPIPAC procedures were scheduled every 6–8 weeks. Patients undergoing concurrent sCT had a wash-out period of 7–10 days before and after each PIPAC.PIPAC procedures were performed under general anesthesia. Venous thromboembolism prophylaxis was given the night before surgery using Enoxaparin 4000 IE. A single intravenous injection of cefazolin 2 g was administered about 30 min prior to surgery.2 pneumoperitoneum was applied. Explorative laparoscopy was carried out and Peritoneal Cancer Index (PCI) was determined. Peritoneal biopsies were taken for histological examination. Ascites volume was documented and removed. A nebulizer  was then connected to an intravenous high-pressure injector  and inserted into the abdomen. The tightness of the abdomen was controlled through a zero flow of CO2. A pressurized aerosol containing oxaliplatin at a dose of 92 mg/sm body surface in 150 mL dextrose solution was applied in patients with intestinal peritoneal carcinomatosis; an aerosol containing Cisplatin 7.5 mg/sm body surface in 150 mL NaCl 0.9% + Doxorubicin 1.5 mg/sm body surface in 50 mL NaCl 0.9% was administered in patients with gastric, ovarian, and primary peritoneal cancer. The chemotherapy injections were remote-controlled and no personnel remained in the operating room during the application. The flow rate was 30 mL/min and the maximal upstream pressure was 200 psi. The aerosol was maintained for 30 min at 37 °C and a pressure of 12 mmHg, then exsufflated via a closed line over two sequential micro-particle filters into the air waste system of the hospital. The single-port access was removed. No drainage of the abdomen was applied. The PIPAC procedure was repeated three times every 6–8 weeks.A midline single-port access (Olympus Quadport + platform) was realized and a 12 mm Hg COThe primary objective was to evaluate the DCR  according to the RECIST criteria. We used an optimal two-stage Simon’s design to differentiate between a DCR of 15%, below which the method is not considered clinically useful, and 30%, which is the DCR of clinical interest with type I and II errors of 0.0477 and 0.1994, respectively. Under these assumptions, we calculated that 19 patients had to be enrolled in the first stage. If more than three radiological responses were observed, the study should proceed to a projected accrual of 55 patients. The observation of a total of at least 13 responses will confirm a DCR of 30%. Under these conditions, the probability of early termination because the treatment is not effective is 0.6841. Considering an expected drop-out rate of 15%, the final sample size was established, at 63 patients. The expected DCR must be confirmed by the execution of at least two PIPAC procedures.Statistical analysis was carried out in the per-protocol population. Demographic data were summarized as frequency with percentage for categorical variables, and median with interquartile range for continuous variables.p-values less than 0.05 were considered statistically significant. Analyses were performed using R version 3.6.0 software.Overall survival and progression free survival curves were estimated using the Kaplan–Meier methods and compared using the log-rank test. Between October 2015 and December 2018, 171 single-port PIPAC procedures in 82 patients presenting PC from different primary tumors were performed. Between October 2015 and October 2017, 63 patients were enrolled in the PI-CaP trial. Data were locked in October 2018, when the last follow up of the last patient occurred. Laparoscopic non-access rate was 2.9% (2/67). In two cases, PIPAC procedure were not performed because of bowel obstruction.n = 6), deterioration of general condition (n = 9), palliative or rescue surgery execution (n = 8). Twenty patients received three PIPACs, 20 patients were not submitted to three PIPAC due to progression of disease (n = 12) and general condition deterioration (n = 8). Patients characteristics are detailed in Sixty-three patients were submitted to at least one PIPAC procedure (ITT: Intention To Treat population); these patients were included in the safety analysis. The Per-Protocol (PP) population was composed of 40 patients (patients submitted to at least two PIPAC procedures). The preplanned 2° PIPAC was not performed due to progression of disease (n = 20), and patients undergoing exclusive PIPAC procedure (n = 20). Diagram of the patients’ flow through the study is depicted in The protocol initially envisaged the enrollment of non-candidates for systemic chemotherapy (sCT). As a result of poor accrual problems, patients performing sCT were also included. Therefore, it was possible to split the population into two subgroups: patients undergoing sCT and PIPAC , 80 (range 45–150), and 88 (range 60–135) min, respectively. Mean hospital stay was 2.4 (range 2–6), 2.4 (range 2–8), and 2.6 (range 2–6) for the first, second, and third operation, respectively.p = 0.72). Median Progression-Free Survival (PFS) was not reached; the 1 and 2-yrs PFS was 58% and 54%, respectively, without any statistically significant difference with or without sCT (p = 0.97).The median Overall Survival (OS) rate of the ITT population was 15 months, with a 1 and 2-yrs OS of 67% and 40%, respectively. There was no statistically significant difference in terms of median OS between the group submitted (15 months) or not (20.6 months) to sCT (p = 0.53)). Median PFS was 7.4 months.Median OS of the PP population was 18.1 months, with a 1- and 2-yrs OS of 61% and 40%, respectively. Even in this subgroup, any statistically significant difference is due to sCT , and seven patients a stable disease (17.5%) shown by a Computed Tomography (TC) scan according to RECIST criteria (version 1.1). After two PIPAC procedures, clinical tumor response at 18F-FDG- PET according to PERCIST criteria (version 1.1) was reported in 13 patients (32.5%). We observed a stable disease in six cases, a partial response in seven, a progression disease in 11 . The degree of histological regression was assessed according to PRGS . After two PIPAC procedures, we reported a PRGS of 1, 2, 3, and 4 in six, one, 16, and six patients, respectively; in 10 patients it was not evaluable. After the third PIPAC, a PRGS of 1, 2, 3, and 4 was registered in three, zero, eight, and one patients, respectively. Overall, nine partial histological regressions, 11 disease stabilities, and two progression of diseases were recorded. In some cases, it was not possible to perform biopsies, or the specimens were not adequate for the assessment.The evaluation of specific circulating tumor markers before and after each PIPAC procedure, considering the several pathologies, were not significant. However, Ca125 for ovarian cancer and DMPM, and CEA and Ca19.9 for gastric and colorectal cancer were taken into consideration. A general tendency to slightly increase was identified after the first procedure, followed by a decrease after the second and the third PIPACs in patients where an objective ORR was found. Safety and tolerability were assessed by collection of adverse events, according to the Common Terminology Criteria for Adverse Events (CTCAE) 4, including physical examination results and laboratory assessments (chemistry and hematology). Complication rate was assessed on the total number of interventions (considering the ITT population).Overall complication rate was 8.1% (10/123). Major complication rate (CTCAE 3–4) was reported in three cases (2.4%).The most common complications were abdominal pain, nausea, hyperthermia, wound infection, anemia, and leucopenia. Only one patient was submitted to reoperation because of bleeding, likely due to surgical procedure. Thirty-day postoperative mortality rate was nihil. Renal and hepatic functions were not impaired.Quality of life was evaluated according to the Short Form 36 (SF-36) health survey before the beginning of the treatment and after each PIPAC procedure during the interval control (IC). The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0–100 scale, under the assumption that each question carries equal weight. The lower the score, the more disability; the higher the score, the less disability.Before first PIPAC, baseline general health was 49, emotional role functioning was 63.5, and bodily pain was 74.5. These sections were measured as 49.5, 63.5, and 71 after the first PIPAC procedure, and 45.5, 64, and 71 after the second one, respectively. Prominent complaints were fatigue, and digestive symptoms, such as nausea and constipation. In In this prospective open label phase 2 study, safety of PIPAC procedure was firstly investigated. No postoperative mortality was reported, and only one CTCAE grade 4 surgery-related complication was registered. In two patients, CTCAE grade 3 morbidity was reported: one patient for anemia, the other one to be readmitted because of nausea and abdominal pain. Minor complications were anemia, amylase increase, leukopenia, and abdominal pain. These results were comparable to that reported in two other phase II studies: Struller  reportedSince PIPAC is still primarily a palliative treatment, quality of life is a significant aspect. Evaluations were made according to the SF-36 health survey before the beginning of the treatment and after each PIPAC procedure during the interval control. Eight scaled scores were investigated . Baseline general health was 49, emotional role functioning was 63.5, and bodily pain was 74.5. These sections were measured as 49.5, 63.5, and 71 after the first PIPAC procedure, and 45.5, 64, and 71 after the second one, respectively . The mosp = 0.53). Median PFS was 7.4 months. The objective was widely achieved, but a limitation of the study was that there could have been a heterogeneous group of patients, in terms of primary neoplasia, treated and not with sCT. It should be emphasized that no statistically significant differences were reported between the two subgroups, neither in terms of DCR, nor survival. This is another aspect that can identify PIPAC as a useful treatment in fragile patients who are no longer able to withstand systemic treatments. If on the one hand having patients within the population undergoing systemic chemotherapy in association with PIPAC can allow a comparison between the two subgroups, on the other it does not allow an optimal evaluation of PIPAC effectiveness. Furthermore, considering the small size of the sample and the heterogeneity of the pathologies, it is even more complex to analyze the results in terms of DCR.In terms of treatment response, we reported a DCR of 35%. The hypothesis of this study was that PIPAC could induce a DCR in ≥30% patients, as assessed by RECIST criteria on the basis of a CT scan. Median OS of the PP population was 18.1 months without any statistically significant difference due to sCT , of 32.5%. It was noted that in many cases, FDG-PET was not specific either due to the histopathologic subtype  or due to inflammatory peritonitis post-PIPAC procedure.Considering the pathologic analysis, satisfying rates of objective histological regression (22.5%) and stability (27.5%) were observed. We must point out that in some cases it was not possible to perform biopsies, or the specimens were not adequate for the assessment.In summary, this study shows that PIPAC is active and well tolerated in patients with PC of different origins, even without additional palliative intravenous chemotherapy. On the other hand, even the combined treatment based on sCT and PIPAC is well tolerated without any significant change in terms of quality of life. The real role and timing of PIPAC in the treatment of PC has yet to be investigated. Large studies with single pathology patient cohorts are necessary to define its use and validate the results.


Gardenia jasminoides) is introduced. Methanol and deionized water were appropriate solvents for pigment recovery with maximum yields of at least 17% from the floral tissue. Pigment separation by thin layer chromatography also confirmed the presence of the carotenoids, which dissolved well in these high-strength polar solvents, in fruit, flower, and leaf materials. The spectral patterns of the extracts from ultraviolet and nuclear magnetic resonance showed maximum absorption at ~420 nm and the chemical shift values were similar to those of crocetin aglycones (crocins) in the methanol extracts of a commercial source of yellow gardenia (fructus or fruit of Gardenia florida). Chemical compositions were then evaluated using aqueous-phase capillary electrophoresis of the methanol extracts. The methanolic extracts of the flowers and fruit had 11 principal ingredients in common. Among these, crocetin and crocin 2 belong to the crocin group and are known to be the major components of commercial yellow Gardenia. This research not only demonstrates a sustainable means of raw material utilization for natural product recovery, but also encourages a movement toward an edible landscape for the community.In this research, a novel source of phytopigment crocins from fully open mature flowers of cape jasmine ( Natural dye extracts have been mainly used as colorants, additives, or antioxidants for the food, pharmaceutical, and textile industries for almost two centuries. However, the development of synthetic chemical dyes has brought about almost complete substitution of natural products owing to their durable and functional properties, such as color stability, time efficiency, and convenience . FortunaGardenia is an evergreen shrub used mostly for landscape functions and is known for its sweet, subtly fragrant flowers. A hybrid variety of this plant, i.e., Gardenia jasminoides Ellis or cape jasmine, has been generally used in Thailand for aromatherapy, hair decoration, and religious services (Gardenia (fructus or Zhizhi) (G. florida L.) is well-recognized in Traditional Chinese Medicine because of its bitter flavor and cold properties. As a result, a medicinal formula containing fructus is used to relieve hepatic and abdominal pains with underlying anti-phlogistic, diuretic, laxative, choleretic, and homeostatic properties .services . There iservices , 10. Theoperties . The fruoperties , 13. Theoperties . The pigar cells –17 and iar cells . Besidesmaturity . MoreoveGardenia from the floral tissue. This study was, therefore, conducted to characterize the pigments from a substitute raw material source that could replace the use of the propagating materials, i.e., the fruit. The outcomes of this study could also become the platforms for the development of novel environmentally friendly additive products for functional food and textile industries as well as encourage the movement toward a sustainably edible landscape.Despite the above-mentioned studies, there is a lack of information on the chemical characteristics of yellow G. jasminoides) were harvested from the botanical collection garden at the Faculty of Agriculture, Chiang Mai University, Thailand. Flowers at their mature stages  and leaves (dark green) were selected . Gardenia fructus (G. florida) were obtained from a local farm located in Mea Ei District, Chiang Mai, Thailand. They were pest free, clean, ca. 2–3 cm in diameter, 5–6 cm long, and yellow-orange in color . All materials were dried at 60°C in a hot-air oven for 48 h and stored at room temperature (25°C) in a room without direct sunlight until used. Moisture, fat, and ash contents were analyzed according to AOAC official methods of analysis , dichloromethane, ethyl acetate, and methanol for 48 h. The debris from the plant materials was removed and the extract was evaporated to dryness under vacuum. The yield (%) of the extracts was then obtained. To adjust the concentration, dried extract (0.5 mg) was redissolved in 100 μL of DIH2O, chloroform, ethyl acetate, and methanol. Aliquots (5 μL) of the extracts were spotted onto silica gel thin-layer chromatography (TLC) plates , dried, and developed in TLC tanks with different types of solvent systems, such polar, medium polar, and non-polar, to separate the polar and non-polar components from the plant materials (Dried tissues (5.0 g each) were ground to fine particles and soaked in 200 mL of each of the following solvents: deionized water  spectra, the extracts (1 mg) were dissolved in deuterated dimethyl sulfoxide (DMSO-d6)/deuterium oxide (D2O) and the spectral data were recorded on an Avance 300 MHz NMR spectrometer . Structural elucidation of the pigments was accomplished by comparison of the 1H NMR spectra as described by Choi et al. -visible spectrophotometer  , 23. Fori et al.  and Soboi et al. .2O (resistance >18 MΩ) and 1% acetic acid at a rate of 4 μL/min. Capillary electrophoresis–mass spectrometry (CE-MS) was performed using a 7100 Capillary electrophoresis system  coupled with quadrupole time-of-flight–mass spectrometry (qToF-MS) and a 6340 Ion Trap . A bare fused silica capillary (ø 50 μm and length 67.5 cm) was flushed step-wise with the prepared buffers according to the protocol described by Posch et al. (3) from the ion trap.For an aqueous system, the background electrolyte consisted of 10 mM ammonium acetate, titrated to pH 4.75 with acetic acid, and a constant positive voltage of +30 kV was applied for separation. The sheath–liquid interface was supplied with a 1:1 mixture of 2-propanol with DIHh et al. . Prior th et al. , 26–28. h et al. , 29. TenAnalyses of the chemical compositions and yields were done in triplicate and reported as the mean ± standard error. Differences between samples were determined by Duncan's multiple range tests in SPSS statistical program v.17 . Principal component analysis (PCA) was conducted to describe and interpret the interdependence of the data using the 2018 trial version of XLSTAT . A Venn plot was generated with BioVinci software .Gardenia spp. The fructus had a fat content as high as 17%, followed by the floral and leaf tissues, respectively. Siwawej and Jarayapun . The value falls within the reference range of ash content in Gardenia fruit  were used. The yellow pigment appeared in high polar organic solvents , mainly from the fruit and floral tissues of Gardenia. Methanol and DIH2O extracts of leaf tissue were green, whereas ethyl acetate extracts of leaf and flower tissues and dichloromethane extracts were black . In a similar study, six bands representing yellow pigments were isolated from Gardenia fruits using high polar solvents (H2O and methanol), which were later identified as crocin and crocetin of the carotenoid groups  together, with data that have been reported from NMR spectroscopy of Gardenia pigments (2O) extracts consisted of the major chemical shifts of CH-10 at 7.51 ppm and CH-10,10′ at 7.44 ppm of the trans form (peaks 1–4) as well as signals at ~2.0 ppm (peaks 13 and14) that are similar to those of crocetins , crocetin monogentiobioside monoglucoside ester, and crocetin diglucoside ester . The relationship between the compounds analyzed from the methanolic extracts was evaluated in the form of mass trace PCA, as shown in Gardenia fruit and flower. Generally, the crocins are able to absorb at 430 nm. The other miscellaneous components, including jasminodiol, genistein, and gardenoside, absorb the maximum wavelength at ~240 nm. In other studies, numerous bioactive ingredients were isolated and identified from fruit of Gardenia, including the iridoids (Gardenia and saffron (Gardenia, such as iridoids and triterpenoids (G. jasminoides and Zhizhi (Gardenia spp. have the potential to be developed into medicinal food and pharmaceutical products (Gardenia could be useful for finding alternative sources of natural food additives in a sustainable manner.The methanolic extracts of the n common . As it wiridoids , 43, whiiridoids . Crocins saffron , 22, 24. saffron . A few srpenoids , 47–49. d Zhizhi . These cd Zhizhi , 52. Thu2O extracts of fully mature flowers of G. jasminoides. They were structurally confirmed by means of NMR patterns and MS after separation by capillary electrophoresis in comparison with those of Gardenia yellow from Zhizhi. The other compounds were iridoids and triterpenoids, which have beneficial bioactivities that could be potential used as food additives and medicinally functional ingredients. In this sense, cape jasmine, a cultural ornamental plant, provides an opportunity to develop sustainable edible landscapes. The research information from this study could also increase the market value of the over-mature flowers that are often discarded.In this study, crocin 2 and crocetin were characterized for the first time from methanol and DIHThe datasets generated for this study are available on request to the corresponding author.The project idea and experimental design was developed and data were analyzed by SS. Sample collections were performed and the manuscript was written by SS and PS. The laboratory experiments were run by SS, KS, WR, and TJ. All authors contributed to the article and approved the submitted version.The 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.


Invasive procedures performed by trained nephrologists can reduce delays in making a definitive vascular access, complications, number of procedures on the same patient, and costs for the Public Health System.to demonstrate that a long-term tunneled central venous catheter (LTCVC) implanted by a nephrologist is safe, effective, and associated with excellent results.A retrospective study analyzed 149 consecutively performed temporary-to-long-term tunneled central venous catheter conversions in the operating room (OR) from a dialysis facility from March 2014 to September 2017. The data collected consisted of the total procedures performed, demographic characteristics of the study population, rates of success, aborted procedure, failure, complications, and catheter survival, and costs.the main causes of end stage renal disease (ESRD) were systemic arterial hypertension and diabetes mellitus, 37.9% each. Patients had a high number of previous arteriovenous fistula (1.72 ± 0.84) and temporary catheter (2.87 ± 1.9) attempts until a definitive vascular access was achieved, while the preferred vascular site was right internal jugular vein (80%). Success, abortion, and failure rates were 93.3%, 2.7% and 4%, respectively, with only 5.36% of complications (minors). Overall LTCVC survival rates over 1, 3, 6, and 12 months were 93.38, 71.81, 54.36, and 30.2%, respectively, with a mean of 298 ± 280 days (median 198 days). The procedure cost was around 496 dollars. Catheter dysfunction was the main reason for catheter removal (34%).Our analysis shows that placement of LTCVC by a nephrologist in an OR of a dialysis center is effective, safe, and results in substantial cost savings. However, catheters for hemodialysis are widely used in current practice: 15-50% of patients in Europe and 60% in the United States had their treatment started with a catheter as primary accessInvasive procedures performed by a nephrologist instead of a vascular surgeon or interventional radiologist, especially in areas of difficult access, can reduce delays in making a definitive vascular access, complications, number of procedures on the same patient, and costs for Public Health System. Therefore, nephrologists have taken the initiative to perform these proceedings themselves. Indeed, recent data have shown that nephrologists can safely and successfully perform these procedures with excellent resultsIn this study, we assessed the effectiveness and safety of a TC conversion to a LTCVC performed by a nephrologist without using fluoroscopy in an outpatient center. We also verified the clinical outcomes, complications, and cost of the procedure.long-term tunneled central venous catheter conversions in the operating room of a dialysis facility from March 2014 to September 2017, in Natal - RN (Brazil). Catheters were placed in the internal jugular or femoral veins. Prophylactic antibiotic was not routinely administered. Reasons for catheter removal were creation of an arteriovenous fistula, transfer to another dialysis modality, recovery of renal function, kidney transplant, death, infection, dysfunction, and accidental removal.This was a retrospective study of incident and non-incident dialytic patients. We performed 149 temporary-to-Data on all inserted catheters, clinical follow-up, and catheter-related complications were recorded by the nephrologist and by the dialysis nursing team. The data collected consisted of the total procedures performed, demographic characteristics, rates of success, aborted procedure, failure, complications and catheter survival, and costs.All procedures were performed by the same nephrologist and a nurse technician in an operating room of the dialysis facility and under sterile conditions, without fluoroscopy assistance, and guided by ultrasound when necessary. Preferred vascular site for implantation, in order of preference, were right internal jugular vein (RIJV), left internal jugular vein (LIJV), and femoral veins (FV). Whenever the LTCVC was in a FV, a new puncture was first attempted in the RIJV, because this site was admittedly a better option. If success was not achieved, the definitive catheter implant was maintained in this site.de novo long-term tunneled central venous catheter placement nearest from the clavicle. This maneuver aims to ensure a smooth curvature and prevent kinking  of the LTCVC. In all patients in our sample were used tip dual lumen catheter , 14.5 French diameter, with an overall and implant cuff-to-tip length ranging from 36-45 and 19-35 cm, respectively, depending on the insertion site, tunnel extension, and patient size. Sedation was not necessary, only local anesthesia with lidocaine 2%.As there was no fluoroscopic assistance, the length of the tunneled catheter inside the vein was based on the chest X-ray performed before conversion, so that the tip of the LTCVC entered the right atrium (5 cm below the mainstream bronchus). If the insertion site of was too high (3 cm from the clavicle), patients were submitted to a TC was converted to LTCVC by advancing a guidewire through one of the venous lumen of the existing temporary catheter, which was then removed. Afterward, a subcutaneous tunnel was created and the catheter passed through the tunnel using the tunneler provided with the catheter kit. The next step consisted of placing a peel-away sheath/dilator combination over the guidewire. The dilator and wire were removed and the catheter was inserted centrally through the sheath, which was peeled away.long-term tunneled central venous catheter (LTCVC) through the tunnel ; 5) Introduction of the “peel-way” sheath by the guidewire and removal of the guidewire; 6) LTCVC placed.1) Temporary catheter (TC) in right internal jugular vein (RIJV), 2-3 cm above the clavicle; 2) Introduction of guidewire and removal of TC; 3) Creation of the subcutaneous tunnel by a dilator-catheter; 4) Passage of the long-term tunneled central venous catheter, situation where a new exit site and tunnel were created.Indications for catheter removal were fistula creation, transfer of therapy modality, recovery of renal function, kidney transplant, death, infection, dysfunctionBlood pressure, heart rate, and oxygen saturation were monitored continuously during the performance of all procedures by a nurse technician.The result for each procedure performed was recorded as a success, failure, or aborted. The procedure was classified as successful if the catheter achieve sufficient blood flow to perform a single hemodialysis treatment and this information was reported by the dialysis facility. Blood flow was set to 300 mL/ min or greaterThe complications observed in this study were classified according of the Society of Interventional RadiologyPhysician fees for anesthetist, surgeons and radiologists, operating and recovery room time and nursing, fluoroscopy assistance, and anesthesia were included in this study because the purpose was to determine the difference in costs from the perspective of the center analyzed. Excluded from the analysis were any tests to evaluate a patient’s underlying medical problem or complication that might have occurred on the same day as catheter placement.® 22 Statistics software.Data are described as frequency distribution and mean and median, as appropriate. Categorical variables were expressed as frequency and percentages. Survival analysis was performed using the Kaplan-Meier method. All statistical analysis was performed using IBM SPSSPatients were predominantly female (52.63%), were in the fifth decade of life (55 ± 15.1 years) and the main causes of ESRD were systemic arterial hypertension (SAH) and diabetes mellitus (DM), 37.58% each one, followed by chronic glomerulonephritis - GN (13.42%). The main comorbidities of the patients were SAH (77.85%), DM (37.58%), heart disease (8.72%), and obesity (4.49%). Patients had a high number of previous AVF (1.72 ± 0.84) and TC (2.87 ± 1.9) attempts until a definitive vascular access was achieved, with the preferred vascular sites being RIJV (79.86%), FV (11.40%), and LIJV (6.05%). Twelve patients had an even higher number of catheters, with 8 (n = 7 patients), 9 (n = 5 patients), and 9 (n = 1 patient) TCs. Time from the first TC placement until TC- LTCVC conversion was 4.2 ± 1.07 months .A total of 139 (93.3%) cases were successful, with only 4 (2.7%) cases aborted, 1 by excessive agitation of the patient and 3 by failure to perform TC-to- LTCVC conversion. The procedure failed (the catheter was removed) in only 6 (4%) patients due to the catheter not showing blood flow. A small number of patients had minor bleeding  and none had a major bleeding or needed a blood transfusion. The main complications  were mild hypotension  and desaturation , with no death, hemodynamic instability, arrhythmias, respiratory failure occurring during or immediately after the procedures or any hospitalizations in the first 30 days after the procedures .The total cost of each procedure was around $ 496 dollars (placement), of which $ 460 (catheter included) were for fixed direct costs and $ 36 for variable costs. Overall LTCVC survival rates over 1, 3, 6, and 12 months were 93.38, 71.81, 54.36, and 30.2%, respectively, with a mean of 298 ± 280 days (median 198 days) - All patients of this study started hemodialysis through TC and the overwhelming majority of them had an elevated number of AVF attempts or catheter exchanges until the placement of the LTCVC. This was due to primary failure of the newly created hemodialysis AV fistula secondary to the high number of diabetic and elderly patients, late failure of a hemodialysis AVF (vascular stenotic lesions), multiple infections of catheter, catheter initially implanted in femoral veins and catheter dysfunction. Additionally, the duration of time required for conversion from TC to LTCVC in dialysis patients was prolonged (4 months).,The technique proposed by our study showed to be safe and effective, even though it was performed in the operating room of a dialysis clinic, with only eight 5.3%) cases of mild complications and a success rate of 93.3%. Our complication rates are in agreement with other publications.3% casesThe major cause of catheter removal was dysfunctionality, probably due to thrombosis, fibrin sheath formation at the catheter tip, malpositioned catheter tip, and kinking. As the procedures were done without fluoroscopy assistance, there may have been kinks (depending on flexion and angle degree) that could not be detected or corrected at the time of catheter placement. Thus, the best ways to optimize catheter flow were to reduce kinks by puncturing the jugular vein as close as possible to the clavicle, and a well-planned approach for the tip of the catheter to be in the right atrium, by an x-ray prior to the procedure. In patients who showed dysfunction of the LTCVC, a chest x-ray was performed to try to diagnose kinks. If positive, it was decided to replace the LTCVC by a TC or another LTCVC, situation where a new exit site and tunnel were created. If a kink was not diagnosed, the use of thrombolysis  was attempted. In both cases, blood flow was improved, at least partially. There were 9 cases of kinks that required replacement of catheters, maintaining the same site.,,A Brazilian groupWith respect to costs, our study showed that expenditures with this type of procedure were much lower when compared to those performed in private hospitals  and in a US hospital Even considering the added costs of subjects who would need an additional fluoroscopy-guided procedure, the cost savings would remain substantial (taking into account the success rate presented). These costs coincide with the data presented by Becker et alIn addition to all the benefits already described, we can add the absence of radiation exposure by the nephrologist. Most interventional nephrologists spend a major portion of their work-time in the procedure room for a number of years and the effects of radiation are cumulative. Most dialysis patients require repetitive procedures usually guided by fluoroscopy. Therefore, the main goal of radiation management in interventional nephrology should be to minimize the unnecessary use of radiationIn conclusion, the data generated from our study suggest that conversion of TC to LTCVC by a nephrologist in outpatient dialysis facilities do not carry higher risks of complications than those done in hospitals, and can serve as a safe alternative to centers that do not have fluoroscopy assistance available. In addition, the data show a substantial cost savings over placement of identical catheters by surgeons or radiologists in a hospital setting.


Keratoconus is an ectatic disorder that is presently considered one of the most prevalent reasons for keratoplasty. Corneal collagen crosslinking (CXL) is the only proven treatment option available that is capable of halting the progression of the disease by stabilizing the cone in 90% of cases, and by also reducing refractive error and maximal keratometry. This study assesses, by means of a 3D morphogeometric analysis procedure developed by our research team, the corneal structure changes that occur immediately after CXL treatment and during a 6 month follow-up period. A total of 19 eyes from 19 patients diagnosed with keratoconus who underwent CXL were included, and several variables derived from the morphogeometric analysis were calculated and evaluated for the pre-operative, 3 month postoperative, and 6 month postoperative states. Significant reductions were detected in central corneal thickness and corneal spherical-like root mean square (RMS) 3 months after surgery, with non-significant regression of the effect afterward. Significant reductions in the total corneal area/volume were found, with some levels of regression after 6 months in certain volumetric parameters. In conclusion, the eyes with higher values for morphogeometric parameters—posterior apex deviation (PAD), anterior minimum thickness point deviation (AMTPD), and posterior minimum thickness point deviation (PMTPD)—seemed more likely to undergo aberrometric improvement as a result of CXL surgery. Keratoconus (KC) is an ectatic disorder characterized by progressive thinning, steepening, and distortion of the cornea, with secondary loss of vision due to unacceptable levels of irregular astigmatism . If leftCorneal collagen crosslinking (CXL) is the only available treatment option that has been demonstrated to halt the progression of the disease . CXL, fiAdvances in diagnostic technologies allow a more comprehensive analysis of the corneal structure, which is not limited only to the geometry of the anterior and posterior corneal surfaces . This maThis cross-sectional research followed Declaration of Helsinki guidelines for the use of human subjects, and was endorsed by the Institutional Ethical Board of the VISSUM Alicante clinic.This research included 19 eyes from 19 patients (ages ranging from 18 to 69) diagnosed with KC and undergoing CXL. They were all included in the IBERIA database for keratoconus, and were obtained at the VISSUM Innovation, Cornea, Cataract and Refractive Surgery Unit, Alicante, Spain, which is a center affiliated with the Miguel Hernandez University of Elche .A single experienced ophthalmologist verified the KC diagnosis by checking the presence of the following signs: evidence for KC in retinoscopy and bio-microscopy , existence of topographical patterns associated with KC on the axial curvature map  over 21 degrees, asymmetric bowtie, and 3 mm inferior–superior mean keratometric difference bigger than 1.4 D), central/paracentral or inferior focal steepening (anterior and/or posterior), and/or corneal thickness reduction.All the surgical procedures were performed by the same experienced surgeon under sterile conditions in an operating room. Before surgery, topical and peribulbar anesthesias were applied and an eyelid speculum was inserted to avoid patients blinking during the surgical procedure and to isolate the corneal surgical zone. The corneal epithelium was mechanically debrided with a manual scraper over an entire 9 mm area from the center of the cornea. A Dresden CXL protocol was applied as previously described . BrieflyThe following were prescribed to be applied: topical moxifloxacin hydrochloride drops , 4 times daily for 7 days; dexamethasone 0.1% drops , 4 times daily in a tapering manner for a total 4 week period; 0.3% hydroxypropyl methylcellulose drops , 6 times daily for 2 months.Thorough ophthalmological examinations were made on all subjects, such as retinoscopy, corrected distance visual acuity (CDVA) assessment, Goldman’s tonometry, slit-lamp bio-microscopy, and dilated fundus examination. A single experienced technician took three consecutive topographical measurements with a Sirius System . Only the measures showing green-colored checkmarks, which correspond to best acquisition quality, were selected for the study. Hereafter, the points of clouds representing both the anterior and posterior corneal topographies were exported in the. CSV format to be subsequently studied in detail by the morphogeometric analysis procedure established and validated by our research team . The samThe morphogeometric analysis procedure applied in this study consisted of two consecutive steps .Data Acquisition. A custom-made script programmed in the Matlab R2017b  software was created to transform each point of the cloud provided by the tomographer in polar coordinates into the Cartesian format. This procedure has been meticulously described in several previous research works ,13,14,15•Sample point spacing: 256;•Surface span planes: 255 for both directions “u” and “v”;•Stiffness of the solution surface: 1.Solid modeling and morphogeometric analysis. Finally, a customized three-dimensional model of the patient’s cornea was created from the surfaces previously generated in Rhinoceros by importing them to the SolidWorks V2018  software ,13,14,15In conclusion, the following variables derived from the above-described morphogeometric analysis were calculated and evaluated for the pre-operative, 3 month postoperative, and 6 month postoperative states  8,9,10,,13,14,15ant: area of the anterior corneal surface [A surface .post: area of the posterior corneal surface [A surface .tot: total area of the corneal surface [A surface .CV: total cornea volume .z-axis [AAD: anterior apex deviation, which is the minimum mean distance between the point of maximum curvature (apex) of the anterior corneal surface and the z-axis .z-axis [PAD: posterior apex deviation, which is the minimum mean distance between the point of maximum curvature of the posterior corneal surface and the z-axis .AMTPD: anterior minimum thickness point deviation, which is the minimum distance between the anterior minimum thickness point and the optical axis that goes through the geometrical center of the anterior corneal surface ,12.PMTPD: posterior minimum thickness point deviation, which is the minimum distance between the posterior minimum thickness point and the optical axis that goes through the geometrical center of the anterior corneal surface ,12.VOLmct: volume contained in the intersection between the solid model of the cornea and a cylinder of revolution with radius × (from 0.1 to 1.5 mm) and its axis defined by the points of minimum corneal thickness of the anterior and posterior corneal surface ,12.VOLaap: volume contained in the intersection between the solid model of the cornea and a cylinder of revolution with radius × (from 0.1 to 1.5 mm) and its axis defined by a straight line perpendicular to the tangent plane to the anterior corneal surface at the apex ,12.VOLpap: volume contained in the intersection between the solid model of the cornea and a cylinder of revolution with radius × (from 0.1 to 1.5 mm) and its axis defined by a straight line perpendicular to the tangent plane to the posterior corneal surface at the apex ,12.p-value of less than 0.05 was considered to be statistically significant.Statistical analyses were performed with a commercially available software package . Data variables were confirmed as being non-normally distributed by means of the Kolmogorov–Smirnov test. The Friedman test was used to assess the statistical significance of differences between consecutive visits (preoperative and postoperative). The Wilcoxon tests with Bonferroni correction were used to analyze the differences between pairs of visits. The Spearman correlation coefficient was utilized to assess the level of correlation between the changes in clinical variables at 3 months post-surgery and the different preoperative data. For all the statistical tests, a p = 0.006) and the corneal spherical-like root mean square (RMS) (p = 0.030) at 3 months after surgery, with a non-significant regression of the effect afterward (p = 0.084). Furthermore, a change in the limit of statistical significance was found in the coma-like RMS during follow-up (p = 0.057). Likewise, reductions were observed in manifest sphere, cylinder, spherical equivalent (SE), mean keratometry, and total and primary coma RMS (p ≥ 0.115). The evaluated dataset included a total of 19 eyes (7 right and 12 left eyes) of 19 patients  who underwent CXL surgery with 6 month postoperative follow-up. tot (p = 0.001) and CV (p < 0.001), with no significant changes afterward (p ≥ 0.816). No significant changes were detected during the follow-up for the other calculated and evaluated morphogeometric parameters (p ≥ 0.076). The change in total CV after 3 months showed a moderate but statistically significant correlation with the change in CCT , and also with preoperative corneal asphericity in the 4.5 mm central area  and spherical aberration . However, the change in CV at 3 months did not correlate with the changes in the spherical-like  and coma-like RMS . In contrast, the change in the spherical-like RMS at 3 months after surgery correlated significantly with preoperative PAD , while the change in the coma-like RMS correlated significantly with the preoperative coma-like RMS , AMTPD , PMTPD , and spherical equivalent . Furthermore, a significant correlation was also noted between the change in CCT and AMTPD .mct, VOLaap, and VOLpap for a radius from 0.1 mm to 1.5 mm) were found 3 months after surgery (p ≤ 0.002), with some level of regression at the end of the follow-up.Several studies have shown that some microstructural changes occur after CXL in eyes with keratoconus ,18,19,203), with a significant positive correlation between the changes in CV and CCT. Other authors have also reported a significant reduction in corneal volume after CXL surgery as calculated by different approaches [In the current series, a significant pachymetric reduction was observed at 3 months post-surgery, with a mean change of 34.5 µm, and a non-significant minimal regression of the effect afterward. This is consistent with previous studies on CXL outcomes showing significant corneal thinning during the early postoperative period, which is partially maintained during the follow-up ,27,29,31proaches ,25,27,29tot, which is coherent if we consider the reduction in corneal thickness and CV. This confirms that the reduction in corneal volume in keratoconus with CXL may have different geometric distribution effects for both corneal surfaces. Indeed the variability among patients in the change observed in parameters such as PAD, AMTPD, or PMTPD was wide. However, the level of irregularity of the corneal structure defined preoperatively by morphogeometric parameters correlated significantly with the changes recorded 3 months after surgery in spherical-like and coma-like aberrations. Specifically, negative correlations were found between the changes in both spherical-like RMS and preoperative PAD, and also in the changes in the coma-like RMS and preoperative AMTPD and PMTPD. This means that a more aberrometric reduction was achieved in those keratoconus cases with higher PAD, AMTPD, and PMTPD values, which is consistent with more severe stages of this disease [For the defined morphogeometric parameters, we found significant changes with surgery only in A disease . This suIn conclusion, CXL induces a significant thinning and decrease in the total and local corneal volume of keratoconus eyes, which relatively continued during the 6 month follow-up. The eyes with higher PAD, AMTPD, and PMTPD values seemed more susceptible to undergoing aberrometric improvement after CXL surgery. The morphogeometric analysis developed by our research group proved to be a useful tool for evaluating and monitoring post-CXL changes in ectatic corneas.


Background: This study aimed to identify the factors associated with the quality of life of young workers of a Social Work of Industry Unit. Methods: This was a cross-sectional study conducted on 1270 workers. Data were collected using a digital questionnaire built on the KoBoToolbox platform that included the EUROHIS-QOL eight-item index to assess quality of life. Demographic, socioeconomic, behavioral, and clinical variables were considered explanatory. The associations were analyzed using the ordinal logistic regression model at a 5% significance level. Results: Men and women had a mean quality of life of 31.1 and 29.4, respectively. Workers that rated their health as “very good” had an odds ratio of 7.4  = 5.17–10.81), and those who rated it as “good” had an odds ratio of 2.9 (95% CI = 2.31–3.77). Both these groups of workers were more likely to have higher levels of quality of life as compared to workers with “regular”, “poor”, or “very poor” self-rated health. Physically active individuals were 30% more likely to have higher levels of quality of life . After adjusting the model by gender, age group, marital status, socioeconomic class, self-rated health, nutritional status, and risky alcohol consumption, the odds ratio of active individuals remained stable . Conclusions: In the present study, self-rated health, physical activity, and gender were associated with young workers’ quality of life. Quality of life (QoL) is an important measure for evaluating the health situation of individuals and populations and is strongly influenced by the constant environmental, technological, economic, and labor relation changes. In this sense, QoL is an important indicator of individual and collective health, provided that it is measured based on its complex conceptual framework ,2,3.Since the establishment of the World Health Organization Quality of Life (WHOQOL) group, the World Health Organization (WHO) expanded the concept of QoL, adding to it the individual’s understanding of their life condition in the context of cultural and social values in response to the expectations and concerns encountered in the development of their life plan ,2.Several factors interfere with QoL; these are related to the multidimensionality and subjectivity of its conceptual aspects. The worker’s lifestyle can be a determining factor for health risk behavior, clinical condition, physical activity (PA), and self-rated health. These elements, in turn, potentially affect QoL ,2,4,5.In Brazil, the industry and commerce sector accounts for approximately 40% of the country’s formal jobs . TherefoQoL levels in workers are affected by their interaction with the labor market, which requires high productivity but offers inadequate working conditions and low pay most of the time. Some workers still live with occupational and chronic-degenerative diseases, which directly interfere with their QoL and promote presenteeism at work ,8.Empirical studies on QoL do not address formal workers; most of the data available on the topic refer to specific groups, such as women, the elderly, and people with chronic diseases. Thus, no information about young and healthy workers, which represents the majority of the workforce, is available. Investigating this topic may contribute to reducing the knowledge gap regarding this group’s QoL levels and add to the theoretical and epidemiological framework of public policies on occupational health.Identifying the QoL levels of workers and recognizing it as a potential indicator of occupational health may allow the development of health promotion actions, which could make the work environment more compatible with an increasing market production without causing occupational pathologies in workers ,9,10. ThThis was a cross-sectional study conducted in Brazil on users of the HealthRise program—a program targeting the reduction of premature death from chronic non-communicable diseases, such as diabetes and hypertension—in Vitória da Conquista, aimed at improving users’ access to primary health services, qualifying care, implementing medical records, and offering special tests to patients with chronic diseases (hypertension and diabetes) .2 [The municipality of Vitória da Conquista is located in Northeastern Brazil, with an estimated population of 338,000 inhabitants in 2019 and a territorial area exceeding 3,700,000 km2 . Most of2 . The munData were collected at Industry Social Service (SESI), a private, non-profit entity, whose mission is to qualify the workforce and promote workers’ health ; thus, tData were collected between August 2017 and July 2018. We sought our study sample from the 3727 workers that scheduled consultations with an occupational physician during this period. However, 339 of them did not attend their consultations, 833 awaited medical evaluation after being dismissed, 516 were from other municipalities, 25 were under 18 years old, and 744 refused to participate in the study, all of which were consequently excluded from the study. Further information about the sample can be found in the “Results” section.Data were collected by trained interviewers  using a digital questionnaire built using the KoBoToolbox platform, on tablets. The questionnaire was adapted from the Brazilian National Health Survey 2013  and incl® portable digital electronic scale was used for measuring weight, with the participants barefoot and wearing light clothing. To measure height, a portable NutriVida® stadiometer was used, with the participants barefoot and in an upright position.Additionally, the objective measurements of weight and height were collected. A properly calibrated SECA 813QoL was considered the outcome variable and was measured using the EUROHIS-QOL eight-item index, an instrument created by WHO together with the WHOQOL group, aimed at developing research instruments that produce health indicators through an economic approach and have a possible application in different countries to facilitate comparison between Brazilian data and data from other countries ,2. The EUROHIS-QOL eight-item index instrument was validated and translated into Brazilian Portuguese. It consists of eight questions based on the four WHOQOL-BREF domains: physical health, psychological health, social relationships, and environment, with each item rated on a five-point Likert-type scale ranging from 1 to 5. The total QoL score is obtained by adding the scores on all items, and ranges from 8 to 40, with higher scores indicating higher QoL . QoL wasCritério de Classificação Econômica Brasil—CCEB) of the Brazilian Association of Research Companies (Associação Brasileira de Empresas de Pesquisa—ABEP), which came into force from 2015, was used with an update of the class distribution in 2016 [Demographic, socioeconomic, behavioral, and clinical variables were considered explanatory variables. The Brazil Economic Classification Criterion  and grouped into two categories: non-obese workers (BMI ≤ 29.9 kg/m2) and obese workers (BMI ≥ 30 kg/m2) [The clinical variables included were self-rated health (14) , and nutritional status, which was classified by body mass index (BMI = weight/height0 kg/m2) ,20,21,22The descriptive analysis of the study variables was initially performed. Continuous variables were represented by means, and categorical variables were represented in simple frequencies and percentages. The homogeneity of variance of means was evaluated by Levene’s test. ANOVA or Brown–Forsythe tests were used to determine the differences between means, and a Tukey’s HSD test was used to show the differences. Two-way ANOVA was used to compare the mean QoL in men and women, taking into account socioeconomic and clinical characteristics. p < 0.20) was used in the model for the explanatory variables. The proportional odds were evaluated by a total likelihood ratio test, comparing the fitted models with models with variable localization parameters. The adjustment quality deviation test indicated that the model had a good fit and significantly predicted the dependent variable. Logistic regression produced estimates, which were calculated by points and intervals with a 95% confidence and a significance level of 5%. Statistical analyses were performed using IBM SPSS Statistics software version 27 . Cumulative odds ordinal logistic regression stepwise format with proportional odds was used to determine the effect of risky behaviors, clinical conditions, and demographic and socioeconomic determinants on QoL levels. A significance level of 20% , and most of them were men (80.0%). Of them, 49.5% belonged to social class C and 62.2% were married or lived with a partner. The predominant work shift was the daytime shift (81%). A total of 86.6% reported having good or very good health. The prevalence of obesity was 14.8%, while that of unhealthy eating was 56%. Tobacco use was reported by only 8.4%, while risky alcohol consumption was reported by 28.7%. A total of 62.3% of the workers engaged in PA daily .The bivariate analysis of socioeconomic and clinical conditions showed a statistically significant difference in the QoL between men and women; men had a higher mean QoL (31.1) than women (29.4). The groups with higher mean QoL were the ≤29 years and ≥50 years age groups with QoL scores of 31.0 and 31.2, respectively, followed by social classes A and B with a score of 31.2, and workers who reported very good health with a score of 33.1 .The bivariate analysis of QoL, including risky behavior, habits, and lifestyle, showed statistically significant differences with higher mean QoL for individuals classified as non-obese (30.9), non-smoker (30.8), and physically active (31.0). However, individuals who practiced risky drinking had a higher mean QoL level (31.2) than those who did not (30.6) . The comparison between the QoL in men and women using two-way ANOVA showed statistically significant differences for all demographic, socioeconomic, behavioral, and clinical variables . The ordinal logistic regression analysis showed that QoL was likely to be 30% higher in individuals who were physically active , and even after the odds ratio was adjusted for gender, age group, marital status, socioeconomic class, self-rated health, nutritional status, and risky alcohol consumption, it remained stable and statistically significant (Model 5) for active individuals  . Males had a higher odds ratio value for QoL than females in all logistic regression models. It is worth noting that after adjusting the model by age group, marital status, and socioeconomic class (Model 3), men were twice as likely to have a higher QoL as women were .Workers who reported having very good  or good  health (Model 5) were approximately six and seven times more likely to have a higher QoL, respectively, when compared to workers who reported having regular, poor, or very poor health . Model 1: Effect of physical activity without adjustment. Nagelkerke R² = 0.006Model 2: Physical activity adjusted by gender, age group, and marital status. Nagelkerke R² = 0.035Model 3: Physical activity adjusted by gender, age group, marital status, and socioeconomic class. Nagelkerke R² = 0.046Model 4: Physical activity adjusted by gender, age group, marital status, socioeconomic class, and self-rated health. Nagelkerke R² = 0.168Model 5: Physical activity adjusted by gender, age group, marital status, socioeconomic class, self-rated health, nutritional status, and risky alcohol consumption. Nagelkerke R² = 0.171The main factors associated with QoL in young workers in the present study were the male gender and regular PA practice, even in the model adjusted  for sociodemographic, economic, behavioral, and clinical variables. The stable QoL level in physically active individuals, even in the analysis model, reinforces the positive association of PA with all QoL domains.The studied population of formal workers comprises young individuals, predominantly males, which is similar to other studies conducted in Brazil, since 56% of formal jobs are occupied by men . AlthougMost workers in the present sample were married, practiced PA, and reported having good or very good health. Moreover, some studies indicate a positive relationship between PA and self-rated health. This association may be due to the benefits generated by the practice of PA, such as reduced incidence of diseases, improved self-esteem, and cognitive ability, and promotion of social contact with people with healthy habits, which may favor a better self-rating of health conditions, which is a good health indicator for the population ,25. OL. Self-rated health has good reliability and validity not only as a predictor of morbidity and mortality but also for identifying the health needs of the formal worker population and, more objectively, for stratifying their clinical health conditions and behavioral attitudes ,26. MostThe study showed better QoL levels among workers who practiced risky drinking. This result may be partially explained by the fact that the workers in this study were mostly young. Another explanation could be that as alcohol consumption is often associated with moments of leisure and partying, it may subjectively be perceived as spending quality time ,27. Gender is an important variable when we consider the historically consolidated differences between men and women, and the same was found in the results of this study. Men had a higher quality of life and occupied more job positions than women did. Several studies on the role of gender in health present possible causes for these differences, including double working hours for women (employment and home activities), number of children, and the difficulty of entering the labor market faced by women ,23. In this sense, the power relations established by a gender bias have historically built the social division of labor, based on biological aspects associated with sexist social stereotypes and cultural norms of appreciation of men, consequently limiting women to unpaid activities and jobs considered to be of little administrative and economic relevance. This trend continues today, as can be seen in the income gap by gender, such that in 2019, Brazilian women had a mean income 11.63% lower than that of men ,29. The Physically active individuals showed higher QoL levels than those who were inactive. We constructed a model in which the main variables of the database were used to better understand their relationship with the outcome of the study (QoL). The main exposure variable in the model was PA, as the available literature shows that there is a relationship between PA and QoL level. The model derived from ordinal logistic regression showed a certain stability of QoL levels in physically active individuals ,31,32. TOur findings support that PA is a variable that directly and indirectly positively influences all domains of QoL  . The resMost workers were considered active. This may be due to the benefits of PA practice, the desire for a better body image, and the availability of public equipment . Moreover, the population mostly comprised young people . HoweverNo statistically significant differences in QoL were found in terms of age and marital status in this study. Although age is an important factor in the labor market, it was not present in the regression and was associated with increased QoL levels. These results differ from those found in the literature . HoweverThe higher socioeconomic classes  had higher incomes, and consequently, greater purchasing power of goods and services, stability in work relationships, and more job satisfaction, which are determining factors for physical and mental health, essential elements for QoL ,26,35. TSelf-rated health is influenced by subjective and objective criteria, and according to previous studies, it is a good predictor of mortality, being a reflection of biological, socioeconomic, and behavioral aspects . We founThe findings of this study should be interpreted considering some methodological limitations. First, the presence of acute pathologies was not assessed when data were collected, which may have influenced QoL levels. Second, in terms of the study design, as cross-sectional studies are limited to identifying associations and causal relationships cannot be established, reverse causality can occur . For exaThe results of this study support the use of QoL as an epidemiological indicator for the planning of health-related arrangements for workers. Because QoL is an indicator of health conditions, it can be adopted into all levels of the healthcare system, especially primary care, which is usually a worker’s first point of contact with the health system, to identify general health needs and diagnose possible occupational diseases. Most of the participant workers engaged in regular PA, and demographic, socioeconomic, clinical, and some behavioral factors had little influence on QoL levels. The results of this study may contribute to guiding the implementation of public policies that systematically promote PA in the daily lives of workers. It also highlights the need for further studies to investigate factors associated with QoL in women to confirm and possibly deepen the understanding of the present results.