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

Published studies and case reports over several decades about the use of neostigmine products, including neostigmine methylsulfate, in pregnant women have not identified any drug-associated risk for major birth defects and miscarriage. However, most of the available data are based on studies with exposure that occurred at the time of caesarean section or labor and delivery. These studies have not identified an adverse effect on maternal or infant outcomes. In animal reproduction studies, no adverse developmental effects were observed after administration of neostigmine methylsulfate to pregnant rats and rabbits during organogenesis with doses up to 0.1 and 0.2 times, respectively, the maximum recommended human dose (MRHD) of 5mg/60kg/person/day based on body surface area (mg/m2).

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in the clinically recognized pregnancies is 2 to 4% and 15 to 20% respectively.

Data

Animal Data

In embryofetal development studies, rats and rabbits were administered neostigmine methylsulfate at human equivalent doses (HED, on a mg/m2 basis) of 1.6, 4 and 8.1 mcg/kg/day and 3.2, 8.1, and 13 mcg/kg/day, respectively, during the period of organogenesis (Gestation Days 6 through 17 for rats and Gestation Days 6 through 18 for rabbits). There was no evidence for a teratogenic effect in rats and rabbits up to HED 8.1 and 13 mcg/kg/day, which are approximately 0.097 times and 0.16 times the MRHD of 5 mg/60 kg, respectively in the presence of minimal maternal toxicity (tremors, ataxia, and prostration). The studies resulted in exposures in the animals well below predicted exposures in humans.

In a pre- and postnatal development study in rats, neostigmine methylsulfate was administered to pregnant female rats at human equivalent doses (HED) of 1.6, 4 and 8.1 mcg/kg/day from Day 6 of gestation through Day 20 of lactation, with weaning on Day 21. There were no adverse effects on physical development, behavior, learning ability, or fertility in the offspring at HED doses up to 8.1 mcg/kg/day which is 0.097 times the MRHD of 5 mg/60 kg on a mg/m2 basis in the presence of minimal maternal toxicity (tremors, ataxia, and prostration). The studies resulted in exposures in the animals well below predicted exposures in humans.
Concomitant use of multiple drugs in most patients with cancer may result in drug-drug interactions (DDIs), potentially causing serious adverse effects. These patients often experience unrelieved cancer-related pain (CRP) during and after cancer treatment, which can lead to a reduced quality of life. Opioids can be used as part of a multimodal pain management strategy when non-opioid analgesics are not providing adequate pain relief, not tolerated, or are contraindicated. However, due to their narrow therapeutic window, opioids are more susceptible to adverse events when a DDI occurs. Clinically relevant DDIs with opioids are usually pharmacokinetic, mainly occurring via metabolism by cytochrome P450 (CYP). This article aims to provide an overview of potential DDIs with opioids often used in the treatment of moderate-to-severe CRP and commonly used anticancer drugs such as chemotherapeutics, tyrosine kinase inhibitors (TKIs), or biologics. A DDI-checker tool was used to contextualize the tool-informed DDI assessment outcomes with clinical implications and practice. The findings were compared to observations from a literature search conducted in Embase and PubMed to identify clinical evidence for these potential DDIs. The limited results mainly included case studies and retrospective reviews. Some potential DDIs on the DDI-checker were aligned with literature findings, while others were contradictory. In conclusion, while DDI-checkers are useful tools in identifying potential DDIs, it is necessary to incorporate literature verification and comprehensive clinical assessment of the patient before implementing tool-informed decisions in clinical practice.
Hepatotoxicity [alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3 times the upper limit of normal (ULN) and total bilirubin greater than 2 times the ULN) has been observed in clinical trials (less than 1% of patients) and postmarketing experience. The hepatotoxicity may be severe and deaths have been reported. Causality of the deaths is uncertain. The hepatotoxicity may occur days to several months after initiation of treatment. Liver function tests (transaminases, bilirubin, and alkaline phosphatase) should be monitored before initiation of treatment, every 4 to 6 weeks during treatment, and as clinically indicated. If changes in liver function are severe, therapy with lapatinib tablets should be discontinued and patients should not be retreated with lapatinib tablets [see Adverse Reactions (6.1)].
PURPOSE: To obtain a tooth paste composition which can remove dental caries and fouling things in oral cavity very effectively by usual teeth-brushing manner in no need of a high-level brushing technique because its cleaning power is markedly improved by a synergistic effect. CONSTITUTION: This tooth paste composition comprises an abrasive (a silica abrasive is particularly suitable) and a hydrogen sulfate compound (particularly sodium hydrogen sulfate or potassium hydrogen sulfate are suitable). The amount of the abrasive is preferably 10-40wt.%, while that of the hydrogen sulfate compound is preferably 0.5-10wt.%. The pH of the composition is preferably adjusted to 4-9, particularly to 6-8 because the hydrogen sulfate compound is acidic. Since the composition has so high cleaning power that the fouling things in oral cavity, for example, plaque causing dental carries and periodontitis can be effectively removed in no need of a high level of brushing technique.  Moreover, the cleaning power is based on physical and physicochemical cleaning mechanisms and so this composition can be applied over a very wide range of fouling matters without restriction of narrow selectivity.
The flipped learning model offers students and faculty members the opportunity to teach a course other than the traditional one. It is a blended teaching method in which the activities carried out in the classroom are integrated outside the classroom and the teaching activities carried out outside the classroom are integrated into the classroom. In this model, students can access videos, presentations or recordings prepared as course materials before coming to class, through technological devices such as computers, tablets and smartphones. Students have the opportunity to watch and listen to the prepared course content wherever and whenever they want, as many times as they want. Watching as many resources as they want according to their own learning speed brings about effective and easy learning. Afterwards, when the student comes to the classroom, the information learned is reinforced by the instructor, and the areas that are not understood are solved with questions and answers. Lesson hours for students who take an active role in the classroom are also important in terms of using time effectively. The student is at the center of this learning method and the student assumes individual learning responsibility. Considering nursing education within the scope of all these beneficial results, it is obvious that effective learning will be achieved. This study aimed to help students easily adapt to the principles of asepsis.

Videos containing the principles of asepsis will be presented to the experimental group students 2 weeks before the infection control course (11/11/2023). Normal lecture and practice periods will begin between (11/11/2023-12/12/2023) and the education will last 4 weeks in total. When the study period ends, students will be given a knowledge test and then again 2 weeks later. The implementation period of the study will last until 20/12/2023.

Control group students will be educated only during the normal course. The research will be conducted with first-year students of Bilecik Şeyh Edebali University Nursing Department.
Acute myocardial infarction (AMI), mainly triggered by vascular occlusion or thrombosis, is the most prevalent cause of morbidity and mortality among all cardiovascular diseases. The devastating consequences of AMI are further aggravated by the intricate cellular processes involved in inflammation. In the past two decades, many studies have reported that regulatory T cells (Tregs), as the main immunoregulatory cells, play a crucial role in AMI progression. This review offers a comprehensive insight into the intricate relationship between Tregs and AMI development. Moreover, it explores emerging therapeutic strategies that focus on Tregs and their exosomes. Furthermore, we underscore the importance of employing noninvasive in vivo imaging techniques to advance the clinical applications of Tregs-based treatments in AMI. Although further research is essential to fully elucidate the molecular mechanisms underlying the effects of Tregs, therapies tailored to these cells hold immense potential for the treatment of patients with AMI.
Patients receive L-arginine IV over 10-20 minutes followed by WBRT approximately 1 hour later for up to 10 days of treatment over 2 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo CT at screening, undergo collection of blood samples and spectroscopy on study, and undergo MRI at screening and follow up.
Cyclosporine: Avoid coadministration of cyclosporine with aliskiren [see Warnings and Precautions ( 5.7) and Clinical Pharmacology ( 12.3)] . 

Itraconazole: Avoid coadministration of itraconazole with aliskiren [see Warnings and Precautions ( 5.7) and Clinical Pharmacology ( 12.3)]. 

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) including selective Cyclooxygenase-2 inhibitors (COX-2 inhibitors): In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, coadministration of NSAIDs, including selective COX-2 inhibitors with agents that affect the RAAS, including aliskiren, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving aliskiren and NSAID therapy. 

The antihypertensive effect of aliskiren may be attenuated by NSAIDs. 

Dual Blockade of the Renin-Angiotensin-Aldosterone System (RAAS): The concomitant use of aliskiren with other agents acting on the RAAS such as ACEIs or ARBs is associated with an increased risk of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Most patients receiving the combination of two drugs that inhibit the renin-angiotensin system do not obtain any additional benefit compared to monotherapy. In general, avoid combined use of aliskiren with ACE inhibitors or ARBs, particularly in patients with CrCl less than 60 mL/min. Monitor blood pressure, renal function, and electrolytes in patients taking aliskiren and other agents that affect the RAAS [see Warnings and Precautions ( 5.4, 5.5, 5.6)]. 

The concomitant use of aliskiren with an ARB or an ACEI in diabetic patients is contraindicated [see Contraindications ( 4)]. 

Furosemide: Oral coadministration of aliskiren and furosemide reduced exposure to furosemide. Monitor diuretic effects when furosemide is coadministered with aliskiren.
Intracortical brain-computer interfaces (iBCIs) enable people with tetraplegia to gain intuitive cursor control from movement intentions. To translate to practical use, iBCIs should provide reliable performance for extended periods of time. However, performance begins to degrade as the relationship between kinematic intention and recorded neural activity shifts compared to when the decoder was initially trained. In addition to developing decoders to better handle long-term instability, identifying when to recalibrate will also optimize performance. We propose a method, "MINDFUL", to measure instabilities in neural data for useful long-term iBCI, without needing labels of user intentions. Longitudinal data were analyzed from two BrainGate2 participants with tetraplegia as they used fixed decoders to control a computer cursor spanning 142 days and 28 days, respectively. We demonstrate a measure of instability that correlates with changes in closed-loop cursor performance solely based on the recorded neural activity (Pearson r = 0.93 and 0.72, respectively). This result suggests a strategy to infer online iBCI performance from neural data alone and to determine when recalibration should take place for practical long-term use.
The eye is one of the most vulnerable parts of the human body. There are many kinds of ophthalmic diseases, which are caused by multiple factors. Generally, ophthalmic diseases have the characteristics of complicated etiology and difficult therapy. With the development of the times, ophthalmic diseases have become a major problem that affects people's lives. Inflammation, a major factor inducing ocular diseases, is one of the most popular research directions. The cGAS/STING pathway is a recently discovered inflammatory signaling pathway, which recognizes double-stranded DNA (dsDNA) as an activation signal to promote the expression of downstream cytokines that promote inflammatory response or autoimmune response. Since most of the current treatments for ophthalmic diseases mainly rely on surgery, it is of positive significance to explore the pathogenesis for the discovery of drug targets. This review summarize the research progress of the cGAS/STING pathway in major ophthalmic diseases by introducing the correlation between classical inflammatory pathway and ophthalmic diseases, in order to predict the research direction and methods targeting the cGAS/STING pathway in the pathogenesis of ophthalmic diseases, and also provide guidance for the mechanism as well as molecular targets of ophthalmic diseases.
Participants consume a meal of bread BGL4 standardised to contain 25 g of available carbohydrates. Sample consumed together with 300 mL of water in up to 15 minutes.
The invention comprises the isonicotinic acid hydrazone of aludrinochrome of the formula <FORM:0911727/IV (b)/1> the preparation thereof by reacting isopropylarterenol with silver oxide to form aludrinochrome and reacting this with isonicotinic acid hydrazide, and haemostatic and diuretic compositions containing the hydrazone and a nontoxic water soluble salt of salicylic acid or 3-hydroxy-2-naphthoi acid (see Group VI).  Specifications 757,137 and 757,138 are referred to.ALSO:Haemostatic and diuretic compositions comprise at least 1.5 parts by weight of a non-toxic, water-soluble salt of 3-hydroxy-2-naphthoic acid or at least 5 parts of a non-toxic, water soluble salt of salicylic acid and 1 part of the isonicotinic acid hydrazone of aludrinochrome (see Group IV (b)) of the formula <FORM:0911727/VI/1> The compositions may also be in forms suitable for enteral or parenteral administration, aqueous solutions containing at least 1 mg. of the hydrazone per cc. of the solution and dilute solutions containing at least 1% by weight of the salicylate salt and at least 0.2% by weight of the 3-hydroxy-2-naphthoic acid salt. Aqueous solutions are lyophilized or spray dried to give dry material for the preparation of tablets. Solutions for injection contain up to 2% benzyl alcohol to reduce pain at the site of the injection.  Specification 757,137 and 757,138 are referred to.
The present invention relates to a process of making a concentrate of coagulation proteins starting with whole human or animal plasma. This concentrate is used as a biological adhesive when extemporaneously mixed to thrombin. The concentrated proteins include mostly fibrinogen, fibrin stabilizing factor (factor XIII) and fibronectin. The claimed process has the advantage of being short of execution while providing an excellent yield of coagulable proteins. No protease inhibitor has to be added during the process. The process involves steps of separation by "salting-out" in presence of amino-6 hexanoic acid which prevents co-precipitation of plasminogen with the desired coagulable proteins. The proteins so obtained are very stable after reconstitution in water for at least 24 hours at room or body temperature. After mixing with thrombin and calcium, the adhesive shows excellent strength and biocompatibility.
PURPOSE:To obtain a product having excellent actions of useful components by blending a ground mushroom with a specific amount of a mixture of plant fine powder, seaweed fine powder, leaf bud fine powder and ginseng fine powder and liquefying. CONSTITUTION:A mushroom such as Lentinus edodes, Lyophylluml aggregatum, Flammulina velutipes, Armillaria matsudake, Pholiota nameko, Grifola frondosa, Auricularia auricula, Gonoderma lucidum or polypore is ground. 100 pst.wt. of the ground mushroom is blended with 5-10 pts.wt. mixed powder of plant fine powder, seaweed fine powder, leaf bud fine powder and ginseng fine powder, stirred and put in a closed container. The blend is allowed to stand at about 30 deg.C constant temperature for several months and liquefied. The prepared herb juice is mixed with given amounts of honey, royal jelly, garlic powder and liquor to produce a mushroom juice.
OBJECTIVES: Chronic urticaria presents a chronic process of recurrent attacks, and its first-line treatment is second-generation antihistamine with limited treatment options. The efficacy of antihistamine varies among individuals and cannot meet the needs of all patients. This study aims to explore the clinical efficacy and safety of Zhiyang Xiaozhen granules combined with antihistamine in the treatment of chronic urticaria patients.
METHODS: We retrospectively analyzed the clinical data of patients with chronic urticaria who visited the Xiangya Hospital of Central South University from April 2020 to March 2021. The patients who received conventional second-generation antihistamine treatment were selected as a control group, while the patients who received combined treatment with Zhiyang Xiaozhen granules on the basis of conventional second-generation antihistamine treatment were selected as an observation group. The differences in the Weekly Urticaria Activity Score (UAS7) and Dermatology Life Quality Index (DLQI) between the 2 groups before and 4 weeks after treatment were compared. The Symptom Score Reduce Index (SSRI) was used to evaluate and compare the efficacy of the 2 treatment regimens.
RESULTS: After 4 weeks of treatment, the UAS7 levels in both groups were significantly reduced (P=0.001 and P<0.001, respectively). The effective rates of the control group and the observation group were 61.11% and 59.38%, respectively when converting UAS7 to SSRI for efficacy evaluation, and there was no statistically significant difference in efficacy between the 2 groups (P>0.05); however, when converting DLQI to SSRI for efficacy evaluation, the effective rates of the control group and the observation group were 33.33% and 46.88%, respectively, and the difference in efficacy between the 2 groups was statistically significant (P<0.001). There were 3 patients with adverse drug reactions related to drowsiness in both groups.
CONCLUSIONS: The combination of Zhiyang Xiaozhen granules and second-generation antihistamine can effectively improve disease activity in patients with chronic urticaria, and the improvement in quality of life is better than that with the second-generation antihistamine alone.
PURPOSE: To obtain an antialopecic agent, having excellent antialopecic actions, hardly causing adverse effects and capable of remarkably suppressing the progress of alopecia due to the use of especially an anticancer agent. CONSTITUTION: This antialopecic agent contains 1-100wt.%, preferably 10-100wt.% n-3-based highly unsaturated fatty acid (e.g. docosahexaenoic acid) as an active ingredient. The fatty acid is preferably >=90% purity in aspects of reduction, etc., in adverse effects. The active ingredient is formulated into a solid pharmaceutical preparation such as a powder, a granule, a capsule or a tablet or a liquid pharmaceutical preparation such as a syrup or an elixir or further a parenteral injection, a suppository, etc., by, as necessary, suitably blending a usually used ingredient therewith. The daily dose is about 0.1-2g/ human expressed in terms of the n-3-based unsaturated fatty acid.
In contrast to sulfonylureas, PRECOSE does not enhance insulin secretion. The antihyperglycemic action of acarbose results from a competitive, reversible inhibition of pancreatic alpha-amylase and membrane-bound intestinal alpha-glucoside hydrolase enzymes. Pancreatic alpha-amylase hydrolyzes complex starches to oligosaccharides in the lumen of the small intestine, while the membrane-bound intestinal alpha-glucosidases hydrolyze oligosaccharides, trisaccharides, and disaccharides to glucose and other monosaccharides in the brush border of the small intestine. In diabetic patients, this enzyme inhibition results in a delayed glucose absorption and a lowering of postprandial hyperglycemia.

Because its mechanism of action is different, the effect of PRECOSE to enhance glycemic control is additive to that of sulfonylureas, insulin or metformin when used in combination. In addition, PRECOSE diminishes the insulinotropic and weight-increasing effects of sulfonylureas.

Acarbose has no inhibitory activity against lactase and consequently would not be expected to induce lactose intolerance.
BACKGROUND: Apixaban and amiodarone are drugs used for non-valvular atrial fibrillation (NVAF) in routine practice. The evidence about apixaban plasma levels in patients who receive apixaban with amiodarone, including bleeding outcomes, has been limited. This study aimed to compare the apixaban plasma levels and bleeding outcomes between apixaban monotherapy and apixaban with amiodarone groups.
METHODS: This study was a prospective, observational, and single-center research which was conducted from January 2021 to January 2022 in NVAF patients who received apixaban at a tertiary care hospital located in the center of Bangkok, Thailand.
RESULTS: Thirty-three patients were measured for their median (5th-95th percentile) apixaban plasma levels. The trough of apixaban plasma level (Ctrough) were 108.49 [78.10-171.52] and 162.05 [87.94-292.88] μg/L in the apixaban monotherapy and apixaban with amiodarone groups, respectively (p = 0.028). Additionally, the peaks of apixaban plasma level (Cpeak) were 175.36 [122.94-332.34] and 191 [116.88-488.21] μg/L in the apixaban monotherapy and apixaban with amiodarone groups, respectively (p = 0.375). There was bleeding that occurred in 7 patients (21.21%); 5 patients in the apixaban monotherapy group and 2 patients in the apixaban with amiodarone group, respectively.
CONCLUSIONS: Amiodarone may increase the peaks and troughs of apixaban plasma levels. The co-administration of apixaban with amiodarone is generally well tolerated. However, the careful observation of bleeding symptoms in individual cases is necessary to ensure safety.