Trends in Biochemical Parameters, Healthcare Resource and Medication Use in the 5 Years Preceding IBD Diagnosis: A Health Maintenance Organization Cohort Study.

BACKGROUND: Few data describing pre-diagnosis changes in patients with inflammatory bowel disease (IBD) exist. We aimed to determine if there is a pattern of change in use of health resources, medications and laboratory results in the years preceding diagnosis. METHODS: This retrospective study used electronic medical records of Maccabi Health Services (MHS). Patients with IBD ≥ 16 years of age and minimum of 5-years follow-up were identified by entry into the MHS IBD registry and included in the analysis. Demographic, clinical, medication and laboratory data were collected. Generalized estimating equation model was applied to study trends and compare between years. RESULTS: This study included 5643 patients with IBD. Of these, 3039 (53.8%) had Crohn's disease (CD), 2322 (41.1%) had ulcerative colitis (UC) and 282 (5%) had indeterminate colitis (IC). Laboratory parameters including white blood cells, platelets and C-reactive protein showed significant increases while haemoglobin and mean cell volume showed significant decreases in mean values in the 2 years prior to diagnosis with stable values prior to that (p < 0.0001). Parameters such as creatinine, total protein and albumin showed significant, progressive decreases in mean values starting 5 years prior to diagnosis (p < 0.0001). Patients with CD had distinct laboratory trends when compared with patients with UC. CONCLUSIONS: Changes in laboratory parameters, healthcare service and medication use occur during the 5-year period before IBD diagnosis. These data can have future clinical applicability by developing a composite score and referral algorithm introducing red flags into primary care visits and appropriate referral for specialist care.

Chronic pain following totally extra-peritoneal inguinal hernia repair: a randomized clinical trial comparing glue and absorbable tackers.

PURPOSE: Chronic pain following inguinal hernia repair occurs in up to 20% of patients. The underlying mechanism probably involves sensory nerve damage and abnormal healing that might be influenced by the materials chosen for mesh fixation. The main objective of this study was to compare glue and absorbable tackers on the rate of chronic pain after surgery in patients undergoing totally extraperitoneal inguinal hernia repair (TEP). METHODS: Patients undergoing (TEP) inguinal hernia repair were enrolled in a single-blind randomized clinical trial and were randomized for mesh fixation with glue (LIQUIBAND FIX 8 Neopharm) or absorbable tackers (SECURE STRAP Johnson & Johnson). Pain was assessed using a validated 4-point verbal-rank scale (none, mild, moderate, and severe) at 1 week, 1 month, 6 months, and 1 year postoperatively. Chronic pain was defined as pain persisting beyond 3 months. RESULTS: Two hundred and eight patients were analyzed. The groups were similar in age, gender, and hernia side. Chronic pain of any intensity was reported in 31.7% (66/208) after 6 months and in 13% (29/208) after 12 months. No differences in postoperative pain were observed between the two forms of mesh fixation. Still, when only those with severe pain were considered, mesh fixation with glue resulted in less pain compared to fixation by tackers (log-rank p = 0.025). At 1 year, 4 symptomatic recurrent hernias were identified in patients whose mesh was fixated with absorbable tackers. CONCLUSIONS: Patients who underwent TEP inguinal hernia repair with mesh fixated by glue suffered from less pain.

European association for endoscopic surgery (EAES) consensus statement on single-incision endoscopic surgery.

BACKGROUND: Laparoscopic surgery changed the management of numerous surgical conditions. It was associated with many advantages over open surgery, such as decreased postoperative pain, faster recovery, shorter hospital stay and excellent cosmesis. Since two decades single-incision endoscopic surgery (SIES) was introduced to the surgical community. SIES could possibly result in even better postoperative outcomes than multi-port laparoscopic surgery, especially concerning cosmetic outcomes and pain. However, the single-incision surgical procedure is associated with quite some challenges. METHODS: An expert panel of surgeons has been selected and invited to participate in the preparation of the material for a consensus meeting on the topic SIES, which was held during the EAES congress in Frankfurt, June 16, 2017. The material presented during the consensus meeting was based on evidence identified through a systematic search of literature according to a pre-specified protocol. Three main topics with respect to SIES have been identified by the panel: (1) General, (2) Organ specific, (3) New development. Within each of these topics, subcategories have been defined. Evidence was graded according to the Oxford 2011 Levels of Evidence. Recommendations were made according to the GRADE criteria. RESULTS: In general, there is a lack of high level evidence and a lack of long-term follow-up in the field of single-incision endoscopic surgery. In selected patients, the single-incision approach seems to be safe and effective in terms of perioperative morbidity. Satisfaction with cosmesis has been established to be the main advantage of the single-incision approach. Less pain after single-incision approach compared to conventional laparoscopy seems to be considered an advantage, although it has not been consistently demonstrated across studies. CONCLUSIONS: Considering the increased direct costs (devices, instruments and operating time) of the SIES procedure and the prolonged learning curve, wider acceptance of the procedure should be supported only after demonstration of clear benefits.

A comparative study of totally laparoscopic distal gastrectomy versus laparoscopic-assisted distal gastrectomy in gastric cancer patients: Short-term operative outcomes at a high-volume center.

OBJECTIVE: Laparoscopic gastrectomy has been established as a standard treatment for early gastric cancer, and its use is increasing recently. Compared with the conventional laparoscopy-assisted distal gastrectomy (LADG), totally laparoscopic distal gastrectomy (TLDG) involves intracorporeal reconstruction, which can avoid the additional incision, resulting in pain reduction and early recovery. This study aimed to compare the short-term postoperative outcomes of TLDG vs. LADG in gastric cancer in a high-volume center. METHODS: A retrospective cohort study was conducted on 1,322 patients who underwent laparoscopic distal gastrectomy from June 2012 to June 2017 at the National Cancer Center, Korea. LADG was performed in the early period before July 2015, and TLDG was applied in the later period. Postoperative short-term outcomes were compared in terms of complication and clinical course between the two groups. Pain score was measured by rating the pain intensity from 0 to 10 points on postoperative day (POD) 1 and 3. RESULTS: A total of 667 patients underwent LADG and 655 patients underwent TLDG. Clinicopathologic characteristics were not different in both groups. Intraoperative estimated blood loss (EBL) was significantly lower in the TLDG group (P<0.001). Postoperative pain scores were significantly lower in the TLDG group than in the LADG group on POD 1 (5.1±1.5vs. 4.8±1.4, P=0.015). First flatus passage after operation was significantly earlier in the TLDG group (3.4±0.8 d vs. 3.2±0.6 d, P<0.001). There were no differences in postoperative complications and hospital stay between the two groups. CONCLUSIONS: Based on the reported short-term postoperative outcomes, TLDG is safe and feasible as well as LADG. Moreover, compared with LADG, TLDG can reduce intraoperative EBL and postoperative pain and enhance the bowel motility in gastric cancer surgery.

Clinical characterization of idiopathic intracranial hypertension in children presenting to the emergency department: the experience of a large tertiary care pediatric hospital.

BACKGROUND: Idiopathic intracranial hypertension (IIH) is a syndrome characterized by elevated intracranial pressure, without evidence of intracranial mass lesion or venous thrombosis on brain imaging. The syndrome occurs mainly in young, fertile, and overweight women but may present in any age group. The aim of this study was to report the presentation, course, and outcomes of older versus younger children presenting with IIH to the emergency department of our large tertiary care hospital during an 8-year period. METHODS: Retrospective chart review (January 2000-December 2008) of all patients younger than 17 years with IIH was performed on the basis of modified Dandy Criteria. The patients were analyzed according to age (<11 years and 11-17 years) and weight centile (<90%, 90%-97%, >97%). RESULTS: Ages ranged from 2 to 16.5 years (mean [SD], 9.71 [4.56] years). Thirty males (46.8%) and 33 females (53.2%) were identified: 30 were prepubertal with a male-female ratio of 1:0.56 and 33 were pubertal with a male-female ratio of 1:2 (P < 0.05). There were no significant differences between the 2 age groups in proportions of children in the 3 predefined weight categories The most common presenting symptom was headache (75%), which was significantly less common in the younger age group compared with the older group (P < 0.01). Papilledema was present in 51 patients (82.3%). Mean (SD) cerebrospinal fluid opening pressure was 378 (16) mm H2O. Findings of brain imaging (mostly computed tomographic scan), performed in all patients, were normal in 42 (67.7%); the most common finding in the remainder was swelling of the optic nerves. CONCLUSIONS: Our results indicate that IIH should be considered in any child with new-onset headache or visual disturbance, irrespective of age, sex, weight, or the presence of known predisposing factors. When IIH is suspected, neuroimaging should be performed promptly to exclude secondary causes of this condition because IIH in children remains a diagnosis of exclusion. Early diagnosis and prompt treatment for IIH can prevent potential visual loss.

Probiotic supplementation in mothers of very low birth weight infants.

OBJECTIVE: Oral probiotic supplementation reduces the risk of necrotizing enterocolitis (NEC) in preterm infants. Concerns about safety and purity of probiotic preparations have limited their use in preterm infants. The authors administered probiotic bacteria to mothers of preterm infants, thereby avoiding the risks of direct exposure of infants to probiotic bacteria. DESIGN: This prospective, randomized, double blind, placebo-controlled trial at the Tel Aviv Medical Center (June 2007-November 2009) examined the effects of maternal oral probiotic supplementation on the incidence of NEC, death, and sepsis in very low birth weight (VLBW) infants fed with maternal breast milk. Mothers were assigned to supplementation with Lactobacillus acidophilus and Bifidobacteria lactis 2 × 10(E) [DOSAGE ERROR CORRECTED] CFU/d or to placebo starting from 1 to 3 days postpartum. The primary outcome measures were NEC, sepsis, and death. RESULTS: In total 49 mothers of 58 VLBW infants were recruited. A total of 25 infants were in the probiotic group and 33 in the placebo group. The overall incidence of Bell stage II to III NEC was 12%, with an incidence of 4% in the infants of the probiotic group and 18.2% in the placebo group (p = 0.12), respectively. Sepsis and mortality rates were similar. CONCLUSION: Postpartum maternal supplementation with probiotic bacteria may decrease the incidence of NEC in breastfed infants.

Autonomic responses in young females with typical vasovagal syncope.

To determine whether young women who have experienced typical vasovagal syncope (tVVS) have altered autonomic response parameters, based on a battery of autonomic tests and maneuvers. Notably, previous studies including small cohorts and a partial list of tests yielded conflicting results. A total of 91 otherwise healthy women were included and divided according to those who had experienced tVVS (39 patients) or not (52 patients). Heart rate variability was evaluated at rest, under strict conditions, during 5 min of standing and during a deep breathing test. Response to Valsalva maneuver and Ewing maneuver were also quantified and compared. Both groups had similar clinical characteristics at baseline. No significant differences were found between the two groups in any of the autonomic parameters evaluated. Autonomic responses in young women who experienced typical vasovagal syncope at baseline were indistinguishable from those who did not. Thus, using non-tilt test autonomic screening tests does not seem to provide diagnostic benefits, and may not be useful in predicting recurrence in this patient population.

Pulmonary Evaluation in Children with Post-COVID-19 Condition Respiratory Symptoms: A Prospective Cohort Study.

Background: Studies on post-COVID-19 condition (PCC) in adults have shown deterioration in pulmonary function tests (PFTs), mainly a diffusion limitation. Among the pediatric population, data are scarce. Aim: To characterize PFTs in children with PCC, including changes over time. Methods: A prospective longitudinal study of children with defined PCC and respiratory complaints who were referred to a designated multidisciplinary clinic from 11/2020 to 12/2022. Results: Altogether, 184 children with a mean age of 12.4 years (SD 4.06) were included. A mild obstructive pattern was demonstrated in 19/170 (11%) at presentation, as indicated by spirometry and/or positive exercise challenge test and/or reversibility post bronchodilators, only three had a previous diagnosis of asthma. Lung volumes and diffusion were normal in all but one patient (1/134, 0.7%). Exhaled nitric oxide levels were elevated in 32/144 (22%). A total of 33 children who had repeated PFTs had normal or near-normal PFTs on follow-up testing, including seven (21.2%) who had mild obstructive PFTs at presentation. Multivariate analysis identified older age [OR 1.36 (95% CI:1.07-1.75)], specific imaging findings (prominent bronchovascular markings (OR 43.28 (95% CI: 4.50-416.49)), and hyperinflation (OR 28.42, 95% CI: 2.18-370.84)] as significant predictors of an obstructive pattern on PFTs. Conclusions: In children with PCC and respiratory symptoms, the most common impairment was a mild obstructive pattern; most were without a history of asthma. Improvement was witnessed in long-term follow-up. In contrast to the adult population, no diffusion limitation was found. Empirical periodic inhaler therapy may be considered in children with factors associated with PFT abnormalities.

Marginal ulcer causing delayed anastomotic perforation following one anastomosis gastric bypass (OAGB).

BACKGROUND: One anastomosis gastric bypass (OAGB) is gaining favor. Anastomotic perforation is a dreaded complication. OBJECTIVES: To describe a series of patients presenting with delayed (> 90 days) perforation of a marginal ulcer (MU) following OAGB. SETTING: Two university hospitals, Israel. METHODS: A retrospective query identifying patients after OAGB admitted with delayed MU perforation. Demographic characteristics, time between OAGB to presentation, clinical, laboratory and imaging at presentation and management data were collected. RESULTS: Between 1/2017-1/2020, 7 patients were identified. Mean body mass index (BMI) and time difference between OAGB and perforation were 14 kg/m2 (range 7-23) and 13 months (range 4-23), respectively. All presented with upper abdominal pain, 4 had concomitant nausea and vomiting. One patient displayed tachycardia, none had fever and 3 exhibited leukocyte abnormalities. C-reactive protein ranged widely (2-311 mg/L). Mean albumin level was 2.9 g/dL (range 1.9-4). Pneumoperitoneum was demonstrated in half of plain abdominal films and all computed tomography (CT) scans. Management was tailored to clinical status. Four patients underwent laparoscopic primary repair with omentopexy. Two patients were initially managed nonoperatively, one eventually requiring conversion to Roux-en-Y gastric bypass (RYGB) while the other recovered without further intervention. One patient underwent exploratory laparotomy and "damage control" management with pouch gastrostomy and double-barrel jejunostomy. Risk factors for MU were present in 4 cases. Mean length of hospital stay was 18 days (range 3-79 days). CONCLUSIONS: Perforation of MU may occur months to years after OAGB even without risk factors. Laboratory results are unreliable. The CT scan is diagnostic. A tailored approach can achieve good outcomes.

Clinical Outcome of Novel Reconstruction of Double Shouldering Technique after Proximal Gastrectomy.

Purpose: Various reconstruction methods have been proposed to reduce reflux after proximal gastrectomy, and we report here a double shouldering technique. The purpose of this study is to compare the novel double shouldering technique with conventional esophagogastrostomy in terms of short term and 3-year clinical outcome. Methods: A retrospective observational case control study was performed on 63 patients for cT1N0 upper third gastric cancer who underwent proximal gastrectomy from January 2012 to November 2016 at the National Cancer Center, Korea. There were 26 patients with conventional esophagogastrostomy, and 37 patients with novel double shouldering technique. The primary outcome was endoscopic reflux esophagitis findings one and three year after surgery according to Los Angeles classification. Secondary outcomes were short term surgical outcome and reflux symptom. Results: There was no significant difference in reflux esophagitis on endoscopic findings at 1 and 3 years after surgery between the two group. The double shouldering (DS) technique group showed significantly better postoperative outcomes with bile reflux at one and three years via endoscopic findings versus conventional esophagogastrostomy (CEG). Operative time and hospital stay were significantly shorter in the CEG group than the DS group. There was no significant difference in terms of reflux symptoms and complications. Conclusion: This novel DS technique is a reconstruction method for use after proximal gastrectomy. It did not show a significant clinical benefit. Development of surgical techniques and further study is needed to identify the optimal reconstruction method after proximal gastrectomy.

Influence of Selective Laser Melting Machine Source on the Dynamic Properties of AlSi10Mg Alloy.

Selective laser melting (SLM) AlSi10Mg alloy has been thoroughly investigated in terms of its microstructure and quasi-static properties, owing to its broad industrial applications. However, the effects of the SLM process on the dynamic behavior under impact conditions remain to be established. This research deals with the influences of manufacturing process parameters on the dynamic response of the SLM on AlSi10Mg at a high strain rate of 700 to 6700 s-1 by using a split Hopkinson pressure bar apparatus. Examinations were performed on vertically and horizontally built samples, processed individually by two manufacturers using a different laser scanning technique on the same powder composition. It was concluded that the fabrication technique does not influence the true stress⁻true strain dependency at strain rates of 700 to 2800 s-1. However, at higher strain rates (4000 to 6700 s-1), this study revealed different plastic behavior, which was associated only with the horizontally built samples. Moreover, this study found different failure demeanors at true strains exceeding 0.8. The dynamic response was correlated with the as-built microstructure and crystallographic texture, characterized using the electron backscattered diffraction technique.

Physiologically relevant reconstitution of iron-sulfur cluster biosynthesis uncovers persulfide-processing functions of ferredoxin-2 and frataxin.

Iron-sulfur (Fe-S) clusters are essential protein cofactors whose biosynthetic defects lead to severe diseases among which is Friedreich's ataxia caused by impaired expression of frataxin (FXN). Fe-S clusters are biosynthesized on the scaffold protein ISCU, with cysteine desulfurase NFS1 providing sulfur as persulfide and ferredoxin FDX2 supplying electrons, in a process stimulated by FXN but not clearly understood. Here, we report the breakdown of this process, made possible by removing a zinc ion in ISCU that hinders iron insertion and promotes non-physiological Fe-S cluster synthesis from free sulfide in vitro. By binding zinc-free ISCU, iron drives persulfide uptake from NFS1 and allows persulfide reduction into sulfide by FDX2, thereby coordinating sulfide production with its availability to generate Fe-S clusters. FXN stimulates the whole process by accelerating persulfide transfer. We propose that this reconstitution recapitulates physiological conditions which provides a model for Fe-S cluster biosynthesis, clarifies the roles of FDX2 and FXN and may help develop Friedreich's ataxia therapies.

Comparative Study of Oil Quality and Aroma Profiles from Tunisian Olive Cultivars Growing in Saharian Oasis Using Chemometric Analysis.

Aroma profile, oxidative stability and quality parameters of virgin olive oil from four cultivars (Chemlali, Chetoui, Koroneiki and Rjim), grown in Rjim Maatoug oasis in southern of Tunisia, were studied for the first time. The olive oil samples were obtained during maturation from a crop season (2012-2013). The results showed the quality parameters, i.e., free fatty acid, UV absorbance at 232 and 270 nm, increases during maturation exceeding the upper limit established by the IOOC norm. Chlorophyll and carotenoid pigments tended to decrease during ripening stages. The trend of oxidative stability, total phenols and Odiphenols exhibited a reduction of antioxidant activity at more advanced stages of maturity. The marks achieved showed that oil quality degradation is due to the great drought of climate: high temperature, high light intensity and low rainfall. Studied aroma profiles of cultivars were also influenced by severe climatic conditions. Twenty-four compounds were characterized, representing 94.8-99.8% of the total volatiles. In all samples, a strong decrease was observed in aldehydes compounds.

Effect of agricultural sites on differentiation between Chemlali and Neb Jmel olive oils.

The chemical composition, oxidative stability, aroma and sensory profiles of virgin olive oils from two Tunisian cultivars, Chemlali and Neb Jmel, grown in two different locations, the center and south of Tunisia, have been evaluated. There were significant differences between the oils from both cultivars when grown in the two different environments. At higher altitude, the oils showed a greater amount of oleic acid, phenols and a higher oxidative stability, while at lower altitude, the oils had higher saturated and linoleic acid contents. The aroma profiles in Chemlali and Neb Jmel cultivars were also influenced by the pedoclimatic conditions, as shown by the difference in volatiles as a function of the geographical area. The volatile compounds of the monovarietal virgin olive oils were identified and compared using headspace solid-phase microextraction (HS-SPME) technique coupled with GC-MS and GC-FID. The proportions of different classes of volatiles of the oils have shown significant differences throughout the obtained oils. These results suggest that besides the genetic factor, the agronomic conditions affect the volatile formation and, therefore, the organoleptic properties of VOO, and can be used to discriminate and characterize the Chemlali and Neb Jmel olive oils from each region.

Clinical Outcome of Novel Reconstruction of Double Shouldering Technique after Proximal Gastrectomy

Purpose@#Various reconstruction methods have been proposed to reduce reflux after proximal gastrectomy, and we report here a double shouldering technique. The purpose of this study is to compare the novel double shouldering technique with conventional esophagogastrostomy in terms of short term and 3-year clinical outcome. @*Methods@#A retrospective observational case control study was performed on 63 patients for cT1N0 upper third gastric cancer who underwent proximal gastrectomy from January 2012 to November 2016 at the National Cancer Center, Korea. There were 26 patients with conventional esophagogastrostomy, and 37 patients with novel double shouldering technique. The primary outcome was endoscopic reflux esophagitis findings one and three year after surgery according to Los Angeles classification. Secondary outcomes were short term surgical outcome and reflux symptom. @*Results@#There was no significant difference in reflux esophagitis on endoscopic findings at 1 and 3 years after surgery between the two group. The double shouldering (DS) technique group showed significantly better postoperative outcomes with bile reflux at one and three years via endoscopic findings versus conventional esophagogastrostomy (CEG). Operative time and hospital stay were significantly shorter in the CEG group than the DS group. There was no significant difference in terms of reflux symptoms and complications. @*Conclusion@#This novel DS technique is a reconstruction method for use after proximal gastrectomy. It did not show a significant clinical benefit. Development of surgical techniques and further study is needed to identify the optimal reconstruction method after proximal gastrectomy.

Clinical Outcome of Novel Reconstruction of Double Shouldering Technique after Proximal Gastrectomy

Purpose@#Various reconstruction methods have been proposed to reduce reflux after proximal gastrectomy, and we report here a double shouldering technique. The purpose of this study is to compare the novel double shouldering technique with conventional esophagogastrostomy in terms of short term and 3-year clinical outcome. @*Methods@#A retrospective observational case control study was performed on 63 patients for cT1N0 upper third gastric cancer who underwent proximal gastrectomy from January 2012 to November 2016 at the National Cancer Center, Korea. There were 26 patients with conventional esophagogastrostomy, and 37 patients with novel double shouldering technique. The primary outcome was endoscopic reflux esophagitis findings one and three year after surgery according to Los Angeles classification. Secondary outcomes were short term surgical outcome and reflux symptom. @*Results@#There was no significant difference in reflux esophagitis on endoscopic findings at 1 and 3 years after surgery between the two group. The double shouldering (DS) technique group showed significantly better postoperative outcomes with bile reflux at one and three years via endoscopic findings versus conventional esophagogastrostomy (CEG). Operative time and hospital stay were significantly shorter in the CEG group than the DS group. There was no significant difference in terms of reflux symptoms and complications. @*Conclusion@#This novel DS technique is a reconstruction method for use after proximal gastrectomy. It did not show a significant clinical benefit. Development of surgical techniques and further study is needed to identify the optimal reconstruction method after proximal gastrectomy.

Changes in serum parathyroid hormone-related protein in breastfed preterm infants.

BACKGROUND: Parathyroid hormone-related protein (PTHrP) has the ability to activate parathyroid hormone receptors and cause hypercalcemia. In a previous study we have demonstrated high concentrations of PTHrP in both term and preterm human milk (HM). PTHrP intestinal absorption and its influence upon calcium homeostasis of the preterm infant have not been studied yet. This study assessed the correlation between PTHrP concentrations in preterm HM and PTHrP in maternal and neonatal serum. STUDY DESIGN: We collected samples of expressed HM obtained from 16 mothers of preterm infants (25-34 weeks of gestation) and drew blood samples from both mothers and infants on postpartum days 2 and 10. PTHrP concentrations were measured by two-site immunoradiometric assay. Blood calcium (Ca), phosphorus (P), and alkaline phosphatase (ALP) concentrations were also measured. RESULTS: Neither maternal nor neonatal PTHrP serum concentrations varied significantly after 10 days of breastfeeding. There was a correlation between PTHrP concentrations in maternal serum and HM concentrations (R² = 0.24, p = 0.04), but not between HM and neonatal serum concentrations or between PTHrP concentrations in HM and preterm serum concentrations of Ca, P, and ALP. CONCLUSIONS: Despite high concentrations of PTHrP in preterm HM, serum concentrations of PTHrP of breastfed preterm infants did not increase over time. There was no correlation between PTHrP concentrations in HM and neonatal serum Ca concentration.

Trends in neonatology and pediatrics publications over the past 12 years.

OBJECTIVE: To test the hypothesis that the number of publications in Neonatology and Pediatrics increases over time, and to verify whether the categories of publications all follow the same pattern over time. DESIGN AND SETTING: We evaluated all Medline articles during 1994-2005. Search was limited to humans, English and to 'newborn' or 'all-child'. We used regression analysis to determine the effect of year-of-publication upon the number-of-publications of each type. RESULTS: Medline reported 36,141 publications in Neonatology and 169,823 in Pediatrics during the evaluation period. There was a significant linear increase in the number of publications in Neonatology and Pediatrics. There was a steady increase over time in Neonatology and in Pediatrics in meta-analyses, reviews and editorials. There was a steady decrease over time in letters in Neonatology, but no significant change in letters in Pediatrics. While there was no significant change in clinical trials (CTs), randomized control trials (RCTs) in Neonatology, there was a significant increase in CTs and RCTs in Pediatrics. CONCLUSIONS: The field of neonatology has not had a significant yearly increase of original studies, but has seen an increase of reviews, meta-analyses and editorials. This contrasts with Pediatrics, which shows a similar increase in reviews, meta-analyses and editorials, but also an increase in the number of CTs and RCTs and guidelines.

Headaches in women undergoing in vitro fertilization and embryo-transfer treatment.

BACKGROUND: In vitro fertilization and embryo transfer has become a common therapeutic modality in modern fertility medicines. Treatment protocols are associated with exaggerated hormonal fluctuations in order to promote multiple follicular development and support of embryo survival. Estrogen is considered to be closely linked to migraine, and its extreme serum level fluctuations have been considered to trigger migrainous headaches. OBJECTIVE: To assess the prevalence, nature, and timing of headache attacks during the course of in vitro fertilization and embryo-transfer treatments. METHODS: We retrospectively evaluated the prevalence and the characteristics of headache among 98 women undergoing in vitro fertilization and embryo transfer therapy using a structured telephone interview. RESULTS: Out of the 98 evaluated patients 25 were migraine sufferers. Headache attacks during the in vitro fertilization and embryo transfer protocol were reported by 28.6% (n = 28) of the women and were significantly more prevalent among the migraineurs. The attacks were of debilitating severity in 82% (n = 23) of patients who reported headaches during treatment. Headache occurred most frequently following gonadotropin-releasing hormone (GnRH) analog induced hypothalamic-pituitary-ovarian axis downregulation, typically associated with very low 17-beta-estradiol (17-beta-E2) serum level. CONCLUSIONS: In vitro fertilization and embryo-transfer treatment might be associated with various degrees of headache. This is mostly observed in patients with migraine headache background and specifically during the downregulation stage of treatment, when very low levels of 17-beta-E2 are observed. (Headache 2005;45:215-219).

The effectiveness of the first dose of BNT162 b 2 vaccine in reducing SARS-CoV-2 infection 13-24 days after immunization: real-world evidence

BackgroundBNT162b2 vaccines showed high efficacy against COVID-19 in a randomised controlled phase-III trial. A vaccine effectiveness evaluation in real life settings is urgently needed, especially given the global disease surge. Hence, we assessed the short-term effectiveness of the first dose of BNT162b2-vaccine against SARS-CoV-2 infection. Given the BNT162b2 Phase-III results, we hypothesized that the cumulative incidence of SARS-CoV-2 infection among vaccinees will decline after 12 days following immunization compared to the incidence during the preceding days. MethodsWe conducted a retrospective cohort study using data from 2{middle dot}6 million-member state-mandated health provider in Israel. Study population consisted of all members aged 16 or above years who were vaccinated with BNT162b2-vaccine between December/19/2020 and January/15/2021. We collected information regarding medical history and positive SARS-CoV-2 polymerase chain reaction test from days after first dose to January/17/2021. Daily and cumulative infection rates in days 13-24 were compared to days 1-12 after first dose using Kaplan-Meier survival analysis and generalized linear models. FindingsData of 503,875 individuals (mean age 59{middle dot}7 years SD=14{middle dot}7, 47{middle dot}8% males) were analysed, of whom 351,897 had 13-24 days of follow-up. The cumulative incidence of SARS-CoV-2 infection was 0{middle dot}57% (n=2484) during days 1-12 and 0{middle dot}27% (n=614) in days 13-24. A 51{middle dot}4% relative risk reduction (RRR) was calculated in weighted-average daily incidence of SARS-CoV-2 infection from 43{middle dot}41-per-100,000(SE=12{middle dot}07) in days 1-12 to 21{middle dot}08-per-100,000(SE=6{middle dot}16) in days 13-24 following immunization. The decrement in incidence was evident from day 18 after first dose. Similar RRRs were calculated in individuals aged 60 or above (44.5%), younger individuals (50.2%), females (50.0%) and males (52.1%). Findings were similar in sub-populations and patients with various comorbidities. ConclusionsWe demonstrated an effectiveness of 51% of BNT162b2 vaccine against SARS-CoV-2 infection 13-24 days after immunization with the first dose. Immunization with the second dose should be continued to attain the anticipated protection. Research in contextO_ST_ABSEvidence before this studyC_ST_ABSWe searched PubMed for follow-up studies regarding the effectiveness of BNT162b2 mRNA Covid-19 Vaccine without any language restrictions. The search terms were (BNT162b2 OR mRNA Covid-19 Vaccine) AND (effectiveness OR real-world OR phase IV) until Jan 15, 2021. We found no relevant observational studies among humans. We also assessed Phase II and Phase III clinical trials with BNT162b2 mRNA vaccine. Added value of this studyTo our knowledge, this is the first and largest phase IV study on the effectiveness of the BNT162b2 mRNA COVID-19 vaccine in real-world settings. Our findings showed that the first dose of the vaccine is associated with an approximately 51% reduction in the incidence of PCR-confirmed SARS-CoV-2 infections at 13 to 24 days after immunization compared to the rate during the first 12 days. Similar levels of effectiveness were found across age groups, sex, as well as among individuals residing in Arab or ultra-orthodox Jewish communities that display an increased COVID-19 risk. Implications of all the available evidenceThe study results indicate that in real life the first dose of the new BNT162b2 mRNA COVID-19 vaccine confers around 50% protection against overall SARS-CoV-2 infections (symptomatic or asymptomatic). Together our findings and the 95% efficacy shown in the phase III trial, suggest that the BNT162b2 vaccine should be administered in two doses to achieve maximum protection and impact in terms of disease burden reduction and possibly reducing SARS-CoV-2 transmission. COVID-19 vaccines should be urgently deployed globally.