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

Azelaic acid is minimally absorbed systemically following topical route of administration, and maternal use is not expected to result in fetal exposure to the drug [see Clinical Pharmacology (12.3)]. 

In animal reproduction studies, embryofetal toxicity was noted when azelaic acid was administered orally during the period of organogenesis at doses 162, 19, and 65 times the maximum recommended human dose (MRHD) in rats, rabbits, and monkeys, respectively. Maternal toxicity was noted at these doses but no malformations were observed in these embryofetal developmental studies (see Data). 

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 clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Data

Animal Data

Dermal embryofetal developmental toxicology studies have not been performed with azelaic acid, 15% gel. Oral embryofetal developmental studies were conducted with azelaic acid in rats, rabbits, and cynomolgus monkeys. Azelaic acid was administered during the period of organogenesis in all three animal species. Embryotoxicity was observed in rats, rabbits, and monkeys at oral doses of azelaic acid that generated some maternal toxicity. Embryotoxicity was observed in rats given 2500 mg/kg/day [162 times the MRHD based on body surface area (BSA) comparison], rabbits given 150 or 500 mg/kg/day (19 or 65 times the MRHD based on BSA comparison) and cynomolgus monkeys given 500 mg/kg/day (65 times the MRHD based on BSA comparison) azelaic acid. No malformations were observed in the oral embryofetal developmental studies conducted in rats, rabbits and cynomolgus monkeys. 

An oral peri- and post-natal developmental study was conducted in rats. Azelaic acid was administered from gestational day 15 through day 21 postpartum up to a dose level of 2500 mg/kg/day. Embryotoxicity was observed in rats at an oral dose of 2500 mg/kg/day (162 times the MRHD based on BSA comparison) that generated some maternal toxicity. In addition, slight disturbances in the post-natal development of fetuses was noted in rats at oral doses that generated some maternal toxicity (500 and 2500 mg/kg/day; 32 and 162 times the MRHD based on BSA comparison). No effects on sexual maturation of the fetuses were noted in this study.
Shear-thinning ophthalmic hydrogel compositions are provided that include from 0.1 to 5.0 wt% (e.g., from 0.1 to 3.5 wt% or from 0.1 to 2.5 wt%) of a microgel particle-forming polymer dispersed in an aqueous carrier; and 0.5 to 100mM of a monovalent and/or polyvalent metal ion salt as a crosslinking agent. The hydrogel composition has a pH in the range of 3 to 8, and the viscosity of the gel composition decreases when the gel is exposed to shear. The composition comprises decorin. Antibiotics such as gentamicin, and anti-inflammatory steroids such as prednisolone may also be included. The composition is suitable for medical use in the treatment of the eye. For example, the compositions are suitable for inhibiting scarring and/or preventing or treating microbial keratitis.
PROBLEM TO BE SOLVED: To provide a remote medical support system, a remote medical support terminal device, etc. which support a treatment of a patient, on the basis of an instruction from a remote area.SOLUTION: A remote medical support system 1 comprises a first terminal device 10 and a second terminal device 20. The first terminal device 10 is a head-mounted display device comprising an imaging part 11 for capturing an image, a see-through display part 12, and a first communication part 17. The second terminal device 20 comprises an input part 21 for receiving an input of input data and a second communication part 25. The first communication part 17 transmits the captured image to the second communication part 25, which transmits the input data to the first communication part 17. The display part 12 superimposes and displays an actual image and the input data.SELECTED DRAWING: Figure 1
OBJECTIVES: This study evaluated patients with occult spinal dysraphism who underwent spinal cord untethering.
METHODS: Twenty-four patients who visited us between 1983 and 2000 were followed-up for a mean duration of 31 years. We studied their lower urinary tract function, skin stigmata, fertility, and work participation.
RESULTS: Questionnaires sent in 2022 revealed that 5 patients had normal voiding (Group A) and 19 patients had abnormal voiding (Group B). Groups A and B underwent spinal cord untethering at a mean age of 5.7 and 13.0 years, respectively, showing a significant statistical difference (p = 0.036). After spinal cord untethering, the number of patients with detrusor normoactivity increased from 0 to 5, i.e., 3 of 6 with detrusor overactivity (50%), 1 of 2 not examined, and 1 of 5 not known. Patients with detrusor underactivity also increased from 11 to 19. Severity of incontinence in the International Consultation on Incontinence Questionnaire-Short Form resulted in a mean value of 2.4 in Group A, which was significantly superior to the mean value of 9.1 in Group B (p = 0.004). Fourteen patients (58.3%) were married and had 21 healthy children. A majority of patients have had full-time jobs. A variety of skin stigmata were present in the lumbosacral region, and changes in vesico-urethral configurations were observed during a video-urodynamic study.
CONCLUSIONS: Our study identified that the early timing of spinal cord untethering performed in neonates or infants and detrusor overactivity prior to untethering surgery are important factors in achieving normal bladder function.
Quantitative measurements of left ventricular volume and ejection fraction are useful in the management of patients with heart disease. Several imaging methods exist, but are limited by cost, invasiveness, or exposure to radio-isotopes. Conventional echocardiography is a noninvasive method that allows estimation of left ventricular size and function; however, quantitative measurements of volume are not widely used due to lack of reproducibility and inaccurate measurements. Real-time three-dimensional echocardiography is a new technique that can be used to derive volume measurements from a single image acquisition. We hypothesize that real-time three-dimensional echocardiography is an accurate method for making left ventricular volume measurements. We therefore propose to measure left ventricular volumes using real-time three-dimensional echocardiography in human subjects and correlate these measurements with magnetic resonance imaging, a more accurate noninvasive method for obtaining these measurements.
AIM: To determine both the risk of first ever ulcer (FEU) and its time to onset in a population which had loss of protective sensation (LOPS) in the foot either with or without loss of protective pain (LOPP).
METHODS: People with diabetes and LOPS without history of FEU presenting in a specialist clinic were included. LOPP was diagnosed by reduced vibration perception and pain perception by using a pinprick simulator. Participants were followed by routine foot checks, phone interview or by letter until the occurrence of a FEU, death or the end of observation period. Survival functions in LOPP strata were compared by log rank test. The hazard ratio (HR) of an FEU in people with compared to people without LOPP was estimated using Cox regression. Time to first ulcer was estimated using the framework of an accelerated failure time (AFT) model.
RESULTS: One hundred and thirty participants were followed up for a median of 48.3 months. Pain perception was lost in 55.4%. Eighteen people with LOPP developed a FEU (25.0%) as opposed to six (10.3%) of those with no LOPP (p = 0.02). Age-sex-adjusted HR for FEU was 3.0 (p = 0.02) for people with compared to people without LOPP. Age-sex-adjusted time to FEU for people with LOPP was approximately half (p = 0.03) than people without LOPP.
CONCLUSIONS: It is suggested that estimation of LOPP is included in routine practice because of its high predictive value for a FEU.
Lichen planus is a chronic, immunological, mucocutaneous disease, characterized by periods of remission and relapse1. Oral lichen planus (OLP) is one of the most common mucocutaneous diseases manifesting in the oral cavity, and the oral mucosa may be the only site of involvement 2, with variable incidence between 0.5% and 4% 3. Three major clinical forms of OLP (reticular, erosive/ ulcerative, and erythematous/atrophic) have been recognized, which could alternate and overlap in a dynamic state as disease progresses. Ulceration is the most severe form that it interferes with eating, speech, and swallowing. Erosive OLP lasts for years, resistance to treatment and spontaneous remissions are rare 4,5. Oral lichen planus is a T-cell-mediated chronic inflammatory oral mucosal disease. Both antigen-specific and non-specific mechanisms may be involved in the pathogenesis of OLP. Antigen-specific mechanisms include antigen presentation by basal keratinocytes to CD4+ helper T-cells that are stimulated to secrete the T helper -1 cytokines IL-2 and IFN-γ. Subsequently, CD8+ cytotoxic T-cells may be activated which then trigger basal keratinocyte apoptosis in OLP. While, non-specific mechanisms include mast cell degranulation and matrix metalloproteinase (MMP) activation in OLP lesions 6. The best known treatment of OLP remains high-potency topical corticosteroids7. However, corticosteroids are known to induce local atrophy, fragility, and telangiectasias, and to promote infections, including acute candidiasis. They also have theoretical risks of lowering local immunity, corticosteroids can exert their effects on the immune system by modulating transcription of genes in cells involved in immune response and other cell types; therefore this mode of action is not selective for the pathogenesis of lichen planus 8-10. A recent Cochrane review showed only little evidence for superiority of the assessed interventions over placebo for palliation of symptomatic OLP and recommended the need of randomized clinical trials on new therapies 11. Pimecrolimus a novel topical selective inflammatory cytokine release inhibitor; that binds to intra-cytoplsmic protein (macrophillin-12) subsequently inhibiting dephosphorylation of nuclear factor of activated T cells by calcineurin; this markedly reduces T-cell cytokine production. Given the T-cell-mediated pathogenesis of OLP, application of this calcineurin inhibitor seems to be a promising therapeutic option 12-14. Several case studies and open-label trials used topical pimecrolimus in treatment of OLP reported beneficial effects 12,15. Few prospective, randomized, vehicle-controlled studies have also been conducted and proved benefit of pimecrolimus over placebo 16,10,17. And one recent prospective study compared the effect of topical pimecrolimus with topical corticosteroid in treatment of OLP 18. The purpose of this study was to compare the effectiveness of topical pimecrolimus 1% with topical corticosteroid, in the treatment of oral erosive and atrophic lichen planus as a prospective, comparative clinical trial.
Hepatic Impairment

The pharmacokinetics of amprenavir have been studied after the administration of LEXIVA in combination with ritonavir to adult HIV-1-infected patients with mild, moderate, and severe hepatic impairment. Following 2 weeks of dosing with LEXIVA plus ritonavir, the AUC of amprenavir was increased by approximately 22% in patients with mild hepatic impairment, by approximately 70% in patients with moderate hepatic impairment, and by approximately 80% in patients with severe hepatic impairment compared with HIV-1-infected patients with normal hepatic function. Protein binding of amprenavir was decreased in patients with hepatic impairment. The unbound fraction at 2 hours (approximate Cmax) ranged between a decrease of -7% to an increase of 57% while the unbound fraction at the end of the dosing interval (Cmin) increased from 50% to 102% [see Dosage and Administration (2.3)].

The pharmacokinetics of amprenavir have been studied after administration of amprenavir given as AGENERASE® Capsules to adult patients with hepatic impairment. Following administration of a single 600-mg oral dose the AUC of amprenavir was increased by approximately 2.5-fold in patients with moderate cirrhosis and by approximately 4.5-fold in patients with severe cirrhosis compared with healthy volunteers [see Dosage and Administration (2.3)].
The invention discloses a technology for manufacturing a compound planting tooth. According to the technology of manufacturing the compound planting tooth, purified polyether-ether-ketone, reinforced fiber materials of which surfaces are processed, aluminium oxide, and SEBS-g-MAH elastic bodies are used as raw materials. 30-38%wt of reinforced fiber material, 10-12%wt of SEBS-g-MAH elastic body and 10-12%wt of aluminum oxide are added into 40-48%wt of polyether-ether-ketone resin and mixed to make polyether-ether-ketone compound materials needed by a planting tooth base and a dental crown. The injection temperature of the compound materials is controlled to be 440 DEG C +/-2 DEG C. The temperature of a mold is controlled between 210 DEG C and 220 DEG C, the materials and a titanium alloy frame are formed in an injection mode and put into cold water with the temperature of 5 DEG C for being cooled to be at the room temperature, and a target tooth base and a target dental crown are obtained. The dental crown has the color of human tooth enamel after the surface of the dental crown is processed. The compound planting tooth obtained with the technology has the advantages of being free of toxics, good in wear-resistant performance, long in service life, and high in breaking strength.
An estimated 38% percent of U.S. adults currently has prediabetes. In individuals aged 65 years and older, the prevalence of prediabetes is 48.8%. Prediabetes is commonly a precursor to the development of type 2 diabetes (t2d). Approximately 5-10% of individuals with prediabetes progress to t2d annually, with 70% developing t2d within their lifetime. Obesity is a significant risk factor for both prediabetes and diabetes, and its prevalence is steadily increasing. In 2020, a combined 66.7% of U.S. adults were classified as overweight or obese. In individuals with prediabetes, interventions leading to a 5-10% decrease in baseline body weight decrease the risk for progression to t2d by 58% at three years and 71% for those aged 60 years and older. At ten and fifteen years, the risk was decreased by 34% and 27%, respectively, and diabetes progression was significantly delayed. Based on these findings, a structured lifestyle intervention program was developed and has been available for public use by the Centers for Disease Control and Prevention (CDC) since 2010. Despite significant resources for the implementation of the Diabetes Prevention Program (DPP), program dissemination and utilization remains low. There are currently 1,882 registered DPP providers nationwide. Due to the modest results attributed to significant efforts to increase the access to and participation in DPP programs across the country, consideration should be given to modifying the current approach to diabetes prevention efforts.

In 2020, approximately 42.4% of American adults had obesity according to the 2021 State of Obesity: Better Policies for a Healthier America report. The prevalence of obesity has been steadily increasing for the last two decades. This upward trend is expected to continue this if effective and sustainable solutions are not employed. According to the CDC, in 2013-2016, 49.1% of adults reported having tried to lose weight within the last year. Searching "weight loss" in any internet browser will return over a billion results ranging from diet plans and weight loss programs to testimonials of individual weight loss journeys. Due to the prevalence of overweight and obesity, the demand for weight loss interventions, and the efficacy of weight reduction for decreasing the risk for t2d development, expanding access to evidence-based weight loss interventions has the potential to significantly advance diabetes prevention efforts nationwide by shifting the focus from preventing prediabetes to treating overweight and obesity. One major gap in the current treatment landscape is how to implement an effective program for adult weight loss with widespread impact.

Given the prevalence and visibility of community pharmacies, this setting is ideal for the dissemination of weight management services. In order to assess the potential impact, this pilot study aims to implement a modified-DPP program and to assess the diabetes risk and health outcomes of individuals choosing to participate in the program..
BACKGROUND: Osteoporotic vertebral compression fracture (OVCF) is usually treated by percutaneous kyphoplasty (PKP) which has limitations. We aimed to evaluate the effects of PKP combined with zoledronic acid (ZOL) injection on OVCF and bone metabolism indices.
METHODS: A total of 600 OVCF patients admitted from June 2015 to June 2020 were randomly divided into group A (PKP alone), group B (PKP combined with ZOL 1 month later) and group C (PKP concurrently combined with ZOL) (N.=200). Before as well as 1 month (before ZOL treatment in group B) and 1 year after PKP, the pain degree, physical function and self-care ability in daily life were assessed, the height and kyphosis Cobb angle of vertebral body with compression fracture and bone mineral densities (BMDs) at different parts were measured, the clinical efficacy, adverse reactions and recurrence of vertebral fractures during 3 years of follow-up were observed, and the serum levels of BAP, BGP, β-CTx and TP1NP were detected.
RESULTS: Compared with groups A and B, group C had significantly reduced visual analogue scale (VAS) and Oswestry disability index (ODI) scores and raised activity of daily living (ADL) score 1 month after PKP (P<0.05). Groups A-C had successively lowered VAS and ODI scores and elevated ADL Score 1 year after PKP (P<0.05). Compared with before PKP, the height of vertebral body with compression fracture significantly increased, and the kyphosis Cobb angle decreased in the three groups 1 month and 1 year after PKP (P<0.05). In group A, the height was lower whereas the angle was larger 1 year after PKP than those 1 month after PKP (P<0.05). One month after PKP, the height was significantly higher and the angle was smaller in group C than those of groups A and B (P<0.05). One year after PKP, the height significantly increased and the angle decreased successively in groups A-C (P<0.05). BMDs at different parts were significantly higher in group C than those of groups A and B 1 month after PKP (P<0.05). One year after PKP, BMDs were highest in group C and lowest in group A (P<0.05). The overall response rate was significantly higher in group C than that in group A (P<0.05). The recurrence rate of fractures was significantly higher in group A than those of groups B and C (P<0.05). The BAP, BGP, β-CTx and TP1NP levels were significantly lower in group C than those of groups A and B 1 month after PKP (P<0.05), and declined successively in groups A-C 1 year after PKP (P<0.05).
CONCLUSIONS: PKP concurrently combined with ZOL exert the most significant therapeutic effects on OVCF, with the lowest recurrence rate of fractures. It relieves pain and improves the physical function and self-care ability in daily life probably by reducing bone metabolism indices, increasing BMD, and maintaining the height and kyphosis Cobb angle of recovered vertebral body.
Herein disclosed is and there is the modified glucagon-like peptide of tiring for glucagon receptor increasing with respect to natural hyperglycemic factor. Further modify described glucagon-like peptide by bridge in formation molecule or with amide group replacement end carboxylic acid, produce the peptide that shows hyperglycemic factor/GLP-1 receptor co-agonists activity. Can be selected from SEQ by Pegylation, acidylate, alkanisation, replacement carboxyl terminal amino acid, the brachymemma of C-end or interpolation? ID? NO:26 (GPSSGAPPPS), SEQ? ID? NO:27 (KRNRNNIA) and SEQ? ID? the carboxyl terminal peptide of NO:28 (KRNR) is modified described polypeptide, further improves dissolubility and the stability of these high-titer glucagon analogs.
Three options for anesthetizing the skin around the horn bud of dairy goat kids were explored. Forty-five <10-day-old Saanen goat kids from were randomly split into five treatment groups (topical anesthetic cream (TA), vapocoolant spray (VS), local anesthetic applied by jet injector (JI), control - no treatment but painful stimulus applied (C), sham - no treatment and touching sites with a finger. The painful stimulus was multiple needle pricks on the skin around the horn bud. The outcome variables measured were heart rate movement, and vocalization during treatment application and administration of a painful stimulus around the horn bud. Heart rates were greater during application of a VS compared to TA.Neither the TA nor the VS appeared to have any effect on the response to the painful stimulus. Kids in the JI group had a 96% reduced odds of expressing a marked pain response in comparison to TA group and an 83% reduction in the odds of a high movement grade during a painful procedure in comparison to the combined results of the other three treatment groups.
Metal nanoparticle agglomerates in various forms may be utilized to promote infection control. Antiseptic substrates may comprise a base substrate and metal nanoparticle agglomerates adhered thereto. Metal nanoparticle agglomerates upon the antiseptic substrates may be contacted with a skin penetration, a skin injury, a burn, a site to be subjected to a skin penetration, or an active skin infection to provide infection control against at least one infective agent. The antiseptic substrates may also facilitate water purification in some cases. Antiseptic fluid formulations comprising a fluid medium having metal nanoparticle agglomerates dispersed therein may be configured for topical or oral use and may similarly afford infection control. Creams, ointments, balms, salves, gels, and liquids or liquid suspensions containing metal nanoparticle agglomerates may be effective for promoting infection control and/or for treating an active infection.
Your doctor will tell you how much medicine to take and when to take it. You will probably start out with a low dose of the medicine. Your doctor may slowly increase your dose until your blood sugar is better controlled. You should take metformin with meals.

Your doctor may have you take other medicines along with metformin to control your blood sugar. These medicines may include insulin shots. Taking metformin hydrochloride tablets with insulin may help you better control your blood sugar while reducing the insulin dose.

Continue your exercise and diet program and test your blood sugar regularly while taking metformin. Your doctor will monitor your diabetes and may perform blood tests on you from time to time to make sure your kidneys and your liver are functioning normally. There is no evidence that metformin causes harm to the liver or kidneys.

Tell your doctor if you:

  * have an illness that causes severe vomiting, diarrhea or fever, or if you drink a much lower amount of liquid than normal. These conditions can lead to severe dehydration (loss of water in your body). You may need to stop taking metformin for a short time.
  * plan to have surgery or an x-ray procedure with injection of dye (contrast agent). You may need to stop taking metformin hydrochloride tablets for a short time.
  * start to take other medicines or change how you take a medicine. Metformin can affect how well other drugs work, and some drugs can affect how well metformin work. Some medicines may cause high blood sugar.