anthonyyazdaniml/gliner-biomed-curated-corpus huggingface dataset:
Risk Summary

There are no data on BRIDION use in pregnant women to inform any drug-associated risks. In animal reproduction studies, there was no evidence of teratogenicity following daily intravenous administration of sugammadex to rats and rabbits during organogenesis at exposures of up to 6 and 8 times, respectively, the maximum recommended human dose (MRHD) of 16 mg/kg. However, there was an increase in the incidence of incomplete ossification of the sternebra and reduced fetal body weights in the rabbit study at 8 times the MRHD, which is a dose level in which maternal toxicity was also observed. In a pre- and postnatal development study, sugammadex treatment resulted in an increase in early postnatal loss, which correlated with maternal behavior (increased incidence of pup cannibalism), at exposures equivalent to the MRHD and higher [see Data] . The background risk of major birth defects and miscarriage for the indicated population are unknown. However, the background risk in the U.S. general population of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies. 

Data

Animal Data

In an embryofetal development study in rats, pregnant animals received daily intravenous administration of sugammadex at 0, 20, 100, and 500 mg/kg (0.2, 1, and 6-times the MRHD of 16 mg/kg/day, respectively, based on AUC comparison) during organogenesis (Gestational Days 6 - 17). No treatment-related maternal and embryofetal changes were observed.

In another embryofetal development study, pregnant New Zealand white rabbits received daily intravenous administration of sugammadex at 0, 20, 65, 200 mg/kg (0.6, 2, and 8 times the MRHD, respectively, based on AUC comparison) during organogenesis (Gestational Days 6-18). Fetal body weight decreases (10 and 14%, respectively) were observed in the offspring at maternal doses of 65 mg/kg and 200 mg/kg. In addition, incomplete ossification of sternebra, and unossified 1st metacarpal were noted at a maternal dose of 200 mg/kg/day. Maternal toxicity was also observed at 200 mg/kg. Considering the observed effects of sugammadex on bone [see Nonclinical Toxicology (13.2)] , it is possible that these findings may be attributable to drug. There was no evidence of teratogenicity at any dose. 

In a prenatal and postnatal development study, pregnant rats were administered sugammadex intravenously at 0, 30, 120, and 500 mg/kg (0.3, 1, and 6 times the MRHD, respectively, based on AUC comparison) from Gestational Day (GD) 6 to Postnatal Day (PND) 21 (corresponding to the beginning of organogenesis through parturition and subsequent pup weaning). Postnatal loss during PND 1-4 was noted across control litters and treated litters from dams receiving sugammadex as a result of pup cannibalization by dams. Overall incidence of affected litters was 2, 1, 4, and 3 litters, respectively, at 0, 30, 120, or 500 mg/kg/day. The reason for the increased cannibalization is not known. An effect of sugammadex on steroidal hormones and/or pheromones cannot be ruled out. In addition, there were no drug-related effects on parturition in rats during evaluations for prenatal or postnatal development.
PURPOSE: Comprehensive sex education (CSE) encourages safer sex behavior for teens and young adults. However, young people recognize a gap between sex education as taught in the classroom and the reality of their sexual experiences. Thus, CSE should take into account the perspectives of its target population.
METHODS: The current project assesses young people's sexual uncertainties by analyzing open-ended responses that were anonymously submitted during in-person sex education sessions. These education programs were administered in middle and high schools in New York State by facilitators from Planned Parenthood Hudson Peconic, Inc. The authors analyzed 1,335 responses from a racially diverse sample of students between the ages of 10 and 21, with 75% of participants between 15 and 17 years old.
RESULTS: Using content analysis, the authors identified 49 recurring content codes in participants' responses, which were organized into 16 categories. Most responses centered around pregnancy, sexually transmitted infections, and how to prevent these outcomes. However, responses also highlighted topics that are not always covered with nuance and transparency, if at all, in sex education (e.g., withdrawal, effectiveness of condoms and other contraception, anal and oral sex). Additionally, gender analyses indicated that girls made greater reference to pain, while boys made greater reference to pleasure, which has implications for girls' development of a positive sexuality.
DISCUSSION: These results should be interpreted with a social equity lens to inform the development of needs-driven, target-based CSE programming.
UNLABELLED: The aim of this study was to evaluate the cutaneous manifestations of immunoglobulin A vasculitis (IgAV) in terms of skin lesion type, distribution and persistence and to investigate the relationship between cutaneous manifestations and system involvement and treatment needs. This retrospective observational study was conducted with 489 IgAV patients who were followed-up for at least 6 months between 2013 and 2024. Demographic characteristics, detailed cutaneous manifestations, clinical findings and treatments were retrieved from electronic medical records. IgAV patients were divided into subgroups according to the presence or absence of vesicles/bullae, necrosis/ulcer, rash spreading above the buttocks and persistence. The groups were analyzed statistically for demographic findings, systemic involvement and treatments. Of 489 patients, 36 (7.4%) had vesicles/bullae and 22 (4.5%) had necrosis/ulcers. 345 (70.6%) patients had cutaneous manifestations limited to the lower extremities and buttocks, 144 (29.4%) had cutaneous manifestations spreading from the lower extremities to the trunk, upper extremities or face. 36 (7.4%) patients had persistent rash for more than 1 month. Patients with necrosis/ulcer had more genital tract involvement (p = 0.04). Patients with rash spreading above the buttocks had more gastrointestinal tract and genital tract involvement (p = 0.014, p = 0.003). Patients with persistent rash had more renal involvement (p = 0.05). Patients with vesicles/bullae, necrosis/ulcer, rash spreading above the buttocks and persistent rash required more steroid treatment (p = 0.003, p = 0.001, p < 0.001, p = 0.03).
CONCLUSIONS: The characteristics of cutaneous manifestations in IgAV patients may be helpful in predicting the course of the disease. The skin lesion type, distribution and persistence of cutaneous manifestations in IgAV are associated with system involvement. In addition, the need for intensive therapy increases in the presence of vesicles/bullae, necrosis/ulcer, rash spreading over the buttocks and persistent rash in IgAV.
WHAT IS KNOWN: • Palpable purpura localized to the lower extremities is the expected cutaneous manifestation of immunoglobulin A vasculitis.
WHAT IS NEW: • The type, distribution and duration of rash in IgAV have effects on the immunoglobulin A vasculitis disease course. • Genital tract involvement is more common in patients with necrosis/ulcers. • Gastrointestinal tract involvement and genital tract involvement are more common in patients with rash spreading above the buttocks. • Renal involvement is more common in patients with persistent rash.
Warfarin Warfarin once daily (q.d.). The individual doses will be titrated as needed to maintain a target INR of 2.0-3.0.
The aim of CARE: Project 3 is to determine the social, behavioral, and biological variables that might contribute to increased risks of an abnormal Pap smear in Appalachian women in Ohio. To accomplish these aims, a case-control study was proposed. Women age 18 and older with an intact cervix, not pregnant, and no current or past history of invasive cervical cancer are recruited at the time of their scheduled Pap smear from clinics/physician practices in Appalachian region of Ohio. Women receiving Pap tests at participating medical clinics/physician practices are recruited for a case control epidemiologic study assessing HPV prevalence and its impact on cervical intraepithelial neoplasia (CIN). Cervical mucus will be collected for Human Papillomavirus (HPV) assays and stored for potential other assays related to HPV. Serum will be drawn for HPV serology and stored for future analysis. Controls are defined as women with a normal Pap smear. Cases are defined as women with abnormal Pap smear (from atypical squamous cells of uncertain significance (ASCUS) to cancer.
It is difficult to characterize complex variations of biological processes, often longitudinally measured using biomarkers that yield noisy data. While joint modeling with a longitudinal submodel for the biomarker measurements and a survival submodel for assessing the hazard of events can alleviate measurement error issues, the continuous longitudinal submodel often uses random intercepts and slopes to estimate both between- and within-patient heterogeneity in biomarker trajectories. To overcome longitudinal submodel challenges, we replace random slopes with scaled integrated fractional Brownian motion (IFBM). As a more generalized version of integrated Brownian motion, IFBM reasonably depicts noisily measured biological processes. From this longitudinal IFBM model, we derive novel target functions to monitor the risk of rapid disease progression as real-time predictive probabilities. Predicted biomarker values from the IFBM submodel are used as inputs in a Cox submodel to estimate event hazard. This two-stage approach to fit the submodels is performed via Bayesian posterior computation and inference. We use the proposed approach to predict dynamic lung disease progression and mortality in women with a rare disease called lymphangioleiomyomatosis who were followed in a national patient registry. We compare our approach to those using integrated Ornstein-Uhlenbeck or conventional random intercepts-and-slopes terms for the longitudinal submodel. In the comparative analysis, the IFBM model consistently demonstrated superior predictive performance.
PURPOSE:To obtain a preventing and therapeutic agent for bone dysmetabolism, especially bone fracture capable of promoting the growth of an osteoblast and increasing an uptake of Ca by using a human neurotrophic factor 3 as a new osteoblast growth factor. CONSTITUTION:This medicine comprises a human neurotrophic factor 3 (NT-3). The medicine is preferably prepared as a solution and intravenously and intramuscularly administered. The daily dose thereof for an adult is preferably 1-500mg expressed in terms of the NT-3. Furthermore, a pharmaceutical preparation for injection is obtained by adding and dissolving a water-soluble excipient, e.g. lactose in water, then distributing the resultant solution into a vial or an ampul, subsequently lyophilizing the solution and hermetically sealing the vial or ampul.
Investigation of the connection between physical activity and social support has gained importance in recent years and there is evidence in the literature showing a positive relationship between social support and physical activity. The aim of this study is to translate the 20-item Physical Activity and Social Support Scale (PASSS), which was developed by Golaszewski and Bartholomew in 2019 to evaluate social support for physical activity, into Turkish, to provide cultural adaptation, and to perform a reliability and validity study of the translated version of the scale in healthy adults. Within the scope of the inclusion criteria, 230 healthy young adult individuals between the ages of 18-35, who do physical activity at least twice a week, who do not have serious limitations that prevent participation in physical activity, and who voluntarily agree to participate in the study by signing their consent, will be recruited. The demographic information of the participants will be obtained with the sociodemographic data form prepared to record the demographic information of the participants, and then the participants will be asked to fill in the "Physical Activity and Social Support Scale" adapted into Turkish. Evaluations of the participants will be made in the form of an online survey via "Google Forms". "Multidimensional Scale of Perceived Social Support and International Physical Activity Questionnaire" will be used for construct validity of the scale, and SF-12 physical and mental component summary scores will be used for convergent and divergent validity. The survey will be repeated every 7-14 days in order to perform the test-retest analysis of the survey. As a result of the study, it is aimed to bring a valid and reliable tool in Turkish to the literature in order to evaluate the importance of social support on physical activity.
PURPOSE: The global prevalence of inflammatory bowel disease (IBD) has steadily risen over the past few decades. Bariatric surgery stands out as an effective strategy for inducing weight loss. This study investigated the impacts of bariatric surgery on the clinical outcomes in patients with IBD.
MATERIALS AND METHODS: Data of hospitalized patients aged ≥ 18 years with IBD were extracted from the Nationwide Inpatient Sample (NIS) 2005-2018. The patients were categorized according to whether they underwent bariatric surgery or not. Univariate and multivariable logistic regression analyses were performed to determine the associations between bariatric surgery, prolonged LOS, unfavorable discharge, hospital mortality, and morbidity.
RESULTS: Data from 807,843 hospitalized patients with IBD were extracted. After exclusions and propensity-score matching, 80,545 patients were analyzed, with 16,109 undergoing bariatric surgery and 64,436 not. A total of 23% of patients had a prolonged LOS, 8% had unfavorable discharge, and the mortality rate was 1.2%. Multivariable analyses revealed that, compared to patients without bariatric surgery, patients with bariatric surgery had significantly decreased odds of prolonged LOS (adjusted odds ratio [aOR], 0.89; 95% CI 0.85-0.93), unfavorable discharge (aOR, 0.83; 95% CI: 0.77-0.89), and mortality (aOR, 0.54; 95% CI: 0.44-0.67), but had increased odds of morbidity (aOR, 1.09; 95% CI 1.04-1.13).
CONCLUSION: In adults with IBD, bariatric surgery is associated with favorable outcomes concerning hospital LOS, discharge status, and mortality. However, the risk of overall morbidity is slightly increased in those who received bariatric surgery compared to those who did not.
Single-port or single-incision laparoscopic surgery (SILS) is esteemed for its efficacy in achieving superior postoperative cosmetic outcomes compared to the conventional laparoscopic approach (Behnia-Willison et al. in Aust N Z J Obstet Gynaecol 52:366-370, 2012; Rogula et al. in Obes Surg 24:1102-1108, 2014; Pitot et al. in Surg Endosc 28:3007-3011, 2014). The introduction of SILS for bariatric procedures can be attributed to the pioneering work of Saber in 2008, who initially applied this technique to laparoscopic sleeve gastrectomy (SG), followed by its utilization in laparoscopic adjustable gastric banding (AGB) (Saber et al. in Obes Surg 18:1338-1342, 2008;Nguyen et al. in Obes Surg 18:1628-1631, 2008). The inaugural application of SILS in Roux-en-Y gastric bypass (RYGB) was documented in 2009, employing a plastic reconstruction methodology. Acknowledging the intricate nature of complex bariatric interventions, we previously detailed a modified SILS approach termed the transumbilical two-site (TUTS) technique for RYGB, which was established as a standard procedure in 2010 (Lee et al. in Surg Obes Relat Dis. 8:208-13, 2012). At that juncture, a solitary article surfaced in 2010 elucidating the dimensions of the small gastric pouch as a mere 8-9 cm, falling short of contemporary surgical requisites for optimal outcomes in one anastomosis gastric bypass (OAGB) (Tacchino et al. in Obes Surg 20:1154-1160, 2010). Notably, the TUTS technique, which was successfully implemented for RYGB, had hitherto not been extended to OAGB due to the complexities associated with creating a slender gastric tube spanning 25 cm. In a pioneering development this year, we have devised a novel strategy to surmount this challenge. The present study is designed to expound upon the transumbilical stapling technique tailored to the unique demands of OAGB.
The standard insulin infusion system consisted in regular human insulin administration through a six-stopcock manifold connected to the distal line of a multilumen central venous catheter by 150 cm tubing. Insulin was systematically infused by syringe pump on the patient proximal port of the manifold. Carrier was infused via pump through the manifold. All others medicines were infused through the other five stopcocks.
FIELD: organic chemistry. SUBSTANCE: synthesis is carried out from β-alanine amino-group of which is protected by addition of tert.-butylhydroxycarbonyl-group following by activation of prepared derivative with alkylchloroformate and N-hydroxysuccinimide. N-Tert. -butoxycarbonyl-b-alanine N-hydroxysuccinimide ester is used for acylation of L-histidine in neutral aqueous-organic medium following by isolation of the end product at neutralization at isoelectric point. Under these conditions the yield of the end product is increased from 40 to 50%, m. p. is increased up to 259-263 C, specific rotation is [α]       2   D         0  = +22 degrees. Clearing effect is increased in the case of human lens opacity. Use of strong bases causing side-effects is excluded. Number of stages in process is diminished. EFFECT: increased activity and quality of the end product, ecological purity of process and its simplification.
The proposed single-arm pilot will examine the feasibility and acceptability of a brief behavioral treatment for reducing suicidal ideation and for increasing reasons for living in caregivers of Veterans with dementia. The proposed study will examine Problem Solving Therapy (PST) using a protocol that teaches skills to address emotional and practical barriers to effective problem solving. The VA usual care practice of collaborative safety planning will also be included in the treatment protocol, herein referred to as enhanced usual care (EUC). For participant safety, all caregivers will receive both PST and EUC. The study design is a single arm. Both PST and EUC are evidence-based interventions, and the treatment is delivered in six sessions. The study will occur at VA Palo Alto.

The assessments and treatments will be conducted entirely by video. Participants will be sent VA-approved tablets. Longitudinal assessment of suicidal ideation and reasons for living will occur at eleven timepoints: baseline, after each of the six weekly treatment sessions, posttreatment (7 weeks), at 1-, 3-, and 6-month follow-up. The recruitment goal is 10 caregivers. Caregivers must be 50 years or older and report suicide ideation to be eligible. Veterans will be excluded and referred for other services if they have psychotic symptoms, bipolar disorder, or severe OCD; an alcohol/substance use disorder; severe or unstable medical conditions; recent head injury (past year) or history of a head injury with loss of consciousness for 24 or more hours; terminal illness; positive cognitive screen indicative of possible dementia; or if they are unable to participate in the study or follow-up sessions. Recruitment will occur through multiple strategies at VA, Vet centers, and in the community to ensure the feasibility of recruiting a total of 10 caregivers.
Nelfilcon A contact lenses worn first, then etafilcon A contact lenses worn second. Each product worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
In the last 20 years, the incidence of AP and rate of hospitalization have steadily increased. Approximately, two-thirds of AP patients will have a mild and self-limiting course of the disease, leaving the remaining one-third experiencing moderately severe to severe disease that is associated with worse outcomes. Overall, the estimated mortality of pancreatitis is 1% however, mortality can be as high as 30% to 40% among patients with AP and organ failure or pancreatic necrosis. Despite numerous randomized clinical trials, there is no medication shown to be successful at treating AP.

AP is associated with fluid deficit secondary to low intake and vomiting. Early intravenous fluid (IVF) resuscitation has been long-established as the initial cornerstone treatment to prevent hypovolemia and subsequent organ failure within the first 48 to 72 hours. The rationale for such intervention is to provide adequate intravascular volume support to counteract fluid shift into the third space. However, available evidence for an effective fluid regimen is lacking with regard to the type of fluid, the optimal rate of administration, and how to assess appropriate goals/targets for adequate resuscitation. Furthermore, the literature has presented conflicting results on whether aggressive versus goal-directed fluid resuscitation will lead to a reduction in mortality and improve outcomes. Although early supportive care with IVF therapy is recommended by the major guidelines, there are potential, serious complications associated with aggressive resuscitation, including volume overload, respiratory failures, intra-abdominal compartments.
A system and method is provided to allow multiple patients to receive peritoneal dialysis treatment at a walk-in facility without having to keep fresh dialysis solution on hand themselves. The walk-in facility is enabled to receive a peritoneal dialysis prescription from a patient, verify the prescription, determine the appropriate treatment for the patient, provide the patient with the appropriate dialysis solution in the appropriate amount, and enable the patient to undergo a dialysis treatment at the facility. The walk-in facility can also be enabled to monitor the patient's home dialysis treatment and to adjust the patient's treatment at the facility accordingly. The facility can be enabled to produce dialysis solution on demand by manufacturing the solution from solution components according to a patient's prescription. Moreover, the facility can use a sorbent system to regenerate effluent dialysis solution into fresh dialysis solution. In one embodiment, the peritoneal dialysis system includes (i) a fill container, and (ii) an energizing unit that removably accepts the fill container, the energizing unit including a sterilization source so configured and arranged relative to the fill container when accepted by the energizing unit to place fluid within the fill container in a physiologically safe condition for delivery to the peritoneal cavity of a patient. FIG. 8A 100-N r18 6a 88b 76 hc 8186b Al434 --,\ 188 Cc /1 t 16 -(432 474-46 466 4W 2 134 42 n 194
Breast milk is vital in the nourishment of premature infants. Early interventions which focus on enhancing infants' oral motor skills required for breastfeeding are needed. There is very limited evidence on early interventions aimed at maintaining rudimentary sucking skills needed for breastfeeding in this high risk population. The main objective of this study is to assess whether non-nutritive sucking on an emptied breast will enhance breast feeding performance in preterm infants.

The target population will consist of clinically stable preterm infants born less born less than or equal to 34 weeks gestational age and whose mother's intention are to breastfeed. Infants will be randomized into the non-nutritive sucking on emptied breast or pacifier group. Both interventions will be administered by mothers. Time to transition to full oral feeding, breastfeeding acquisition at hospital discharge and breastfeeding duration at six months of age will be monitored.