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

There are no available data with SOFDRA use in pregnant women to evaluate for drug-associated risks of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, subcutaneous administration of sofpironium bromide to pregnant rats and rabbits during the period of organogenesis resulted in no significant adverse effects at doses 31 and 10 times, respectively, the maximum recommended human dose (MRHD) ( see Data). 

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

Data

Animal Data

In an embryofetal development study in rats, sofpironium bromide was not associated with embryofetal lethality or fetal malformations at subcutaneous dose levels of 1, 3, and 10 mg/kg/day administered during the period of organogenesis. The maternal and fetal survival, growth and development no observed adverse effect level (NOAEL) was 10 mg/kg/day (31 times the MRHD based on AUC comparisons).

In an embryofetal development study in rabbits, sofpironium bromide was administered by subcutaneous injection to pregnant rabbits at doses of 0.4, 2 and 10 mg/kg/day during the period of organogenesis. Maternal toxicity as evidenced by decreased maternal body weight gain and feed consumption was observed in all sofpironium bromide treated groups. The decrease in maternal body weight was considered severe at 10 mg/kg/day and was associated with embryofetal lethality. The maternal toxicity NOAEL could not be established in the study. The NOAEL for embryo-fetal development toxicity was 2 mg/kg/day (10 times the MRHD based on AUC comparison). Fetal malformation was not observed with sofpironium bromide treatment at doses up to 10 mg/kg/day (57 times the MRHD based on AUC comparison) in rabbits.

In a pre- and postnatal development study, sofpironium bromide was administered by subcutaneous injection to pregnant rats at doses of 1, 3 and 6 mg/kg/day beginning on gestation day 6 through lactation day 20. Maternal toxicity associated with a 17% decrease in body weight gain noted at 6 mg/kg/day (approximately 19 times the MRHD based on AUC comparisons) when compared to the control group. No sofpironium bromide-related effects on prenatal and postnatal development, neurobehavioral or reproductive performance of offspring were noted at doses up to 6 mg/kg/day (approximately 19 times the MRHD based on AUC comparison).
The Bobath based exercises for 60 minutes will be formed according to the needs of the individual and will involve trunk exercises such as placing, stretching, functional reach, rotations, functional strengthening and, balance and walking exercises etc. It will be performed 3 days a week for 8 weeks.
The invention discloses single-type melanins, their preparation methods and their applications in drugs and cosmetics. The preparation method comprises that a dihydroxynaphthlene-melanin (DHN-melanin) in powder form is prepared through a reaction of 1,8-dihydroxynaphthlene as a raw material and NaNO2 in an acid condition, and a DHN-melanin in flake form is prepared through a catalytic action of a fungus Daldiniaeschscholzii IFB-TL01 extracellular crude protein. The melanins prepared respectively in the two forms both have strong activities of elimination of hydroxyl free radicals. The melanins can be utilized in cosmetics and have effects of oxidation and radiation resistance and hydroxyl free elimination. The melanins can be utilized in hair colorings and have adornment effects. The melanins also can be utilized in the biological insecticide field and act as photoprotectants. The melanins are suitable for the biomedical technical field comprising drugs, cosmetics and the like.
PURPOSE:A cardiotonic agent, containing a specific carboxylic acid derivative or a salt thereof as an active constituent, having increasing action on myocardial contraction and coronary blood stream and little influence on heart rate, and useful for treating cardiopathy, e.g. cardiac insufficiency, etc. CONSTITUTION:A cardiotonic agent containing a compound expressed by the formula (R<1> is benzoyl having lower alkoxy which is a substituent group on the phenyl ring) or a salt thereof as an active constituent. The compound expressed by the formula is found to have increasing action on myocardial contraction (positive inotropic action) and to be utilizable as a cardiotonic agent for treating cardiopathy, e.g. congestive cardiac insufficiency, etc. Furthermore, the agent is characterized by having increasing action on coronary blood stream and little influence on heart rate. The dose thereof is preferably 0.01-10mg/kg/day. Preferably, 0.1-200mg active constituent is contained in the unit administration form.
The invention provides a distributed monitoring system and a distributed monitoring method. The distributed monitoring system includes: the system comprises a cloud server, a client system, a medical system and a third party verification mechanism. The cloud server receives the plurality of medical data after operation and encryption from the medical system and receives the monitoring data from the client system. And after the cloud server receives the monitoring data from the client system, transmitting the identification key corresponding to the monitoring data to the client system. The third-party verification mechanism downloads the monitoring data and the medical data from the cloud server, judges whether the monitoring data are abnormal or not based on the medical data to generate a judgment result, and then transmits the judgment result to the cloud server. And after receiving the identification key from the client system, the cloud server transmits a judgment result corresponding to the identification key to the client system.
BACKGROUND: The treatment of chronic limb-threatening ischemia (CLTI) involves a broad spectrum of therapies including many new and emerging techniques. To standardize the results of studies examining this pathology and to allow critical analysis and comparison between studies, the Society for Vascular Surgery (SVS) recommended reporting standard guidelines for the endovascular management of CLTI in 2016. Research studies that do not adhere to complete reporting standards are often more ambiguous in impact and external validity, leading to bias and misinformation that has potentially damaging effects on clinical decision-making. We thus sought to examine adherence to and factors associated with noncompliance with these recommended guidelines.
METHODS: A literature database search was conducted to include all clinical trials, randomized controlled trials, and retrospective comparative studies written in English examining the endovascular treatment of peripheral artery disease (PAD)/CLTI from January 2020 to August 2022. Systematic reviews, case reports, and meta-analysis were excluded. The manuscripts were reviewed for adherence with the SVS guidelines (overall and by guideline subcategories based on demographics, treatment methods, and outcomes), and factors associated with this adherence were determined. These data were used to calculate descriptive and comparative statistics.
RESULTS: Fifty-four manuscripts were identified from this time frame. On average, articles reviewed reported on 42.0% of the SVS reporting standards (range, 25.0-65.2%, Fig 1) with 74.1% of articles (n = 40) not adhering to at least 50.0% of the standards. Manuscripts most completely followed guidelines regarding "patient factors" and were least likely to demonstrate adherence to the description of CLTI and study complications. Within the guideline subcategories, complete adherence to guidelines was not demonstrated in any manuscript in stent trials, disease outcome measures, technical outcome measures, patient factors and critical limb ischemia description, and complete adherence rates within the other subcategories was low (range, 5.6-18.6%). Studies conducted within the United States and those with industry sponsorship were more likely to adhere to >50% of the reporting standards (P < 0.05). Journal impact factor, year of publication, and number of authors had no correlation to the percent adherence to guidelines in specific categories or adherence overall.
CONCLUSIONS: Adherence to reporting standard guidelines for endovascular treatment of lower extremity PAD specifically outlined by the SVS is suboptimal regardless of the quality of the journal the research is published in. Increasing adherence to reporting standards to provide a framework for comparison of studies across techniques used should be prioritized by authors, journal editors, and vascular societies.
PURPOSE:To obtain a safe skin-whitening agent for external use having excellent effect to suppress melanogenesis and useful as face lotion, cream, etc., free from side effect by using rubiginic acid or rubiginol as an active component. CONSTITUTION:The objective agent contains rubiginic acid or rubiginol as an active component. Rubiginic acid or rubiginol produced by the cultivation of microorganisms or by chemical synthesis can be used as the component. The amount of the active component in the agent is 0.001-20.0wt.%, preferably 0.5-10.0wt.%. For example, a face lotion can be prepared by dissolving a humectant (e.g. glycerol), a skin nutrient, etc., in purified water, mixing the solution with ethyl alcohol containing a preservative, a perfumery, etc., as solutes at room temperature and compounding the necessary amount of the above active component to the obtained cosmetic base. Rubiginic acid has a structure of formula I and rubiginol has a structure of formula II.
Occupational crystalline silica (CS) particle exposure leads to silicosis. The burden of CS-associated disease remains high, and treatment options are limited due to vague mechanisms. Here we show that pulmonary CD4+ tissue-resident memory T cells (TRM) accumulate in response to CS particles, mediating the pathogenesis of silicosis. The TRM cells are derived from peripheral lymphocyte recruitment and in situ expansion. Specifically, CD69+CD103+ TRM-Tregs depend more on circulating T cell replenishment. CD69 and CD103 can divide the TRM cells into functionally distinct subsets, mirroring the immuno-balance within CD4+ TRM cells. However, targeting CD103+ TRM-Tregs do not mitigate disease phenotype since the TRM subsets exert immunosuppressive but not pro-fibrotic roles. After identifying pathogenic CD69+CD103- subsets, we highlight IL-7 for their maintenance and function, that present a promising avenue for mitigating silicosis. Together, our findings highlight the distinct role of CD4+ TRM cells in mediating CS-induced fibrosis and provide potential therapeutic strategies.
Pathological images of gastric cancer serve as the gold standard for diagnosing this malignancy. However, the recurrence prediction task often encounters challenges such as insignificant morphological features of the lesions, insufficient fusion of multi-resolution features, and inability to leverage contextual information effectively. To address these issues, a three-stage recurrence prediction method based on pathological images of gastric cancer is proposed. In the first stage, the self-supervised learning framework SimCLR was adopted to train low-resolution patch images, aiming to diminish the interdependence among diverse tissue images and yield decoupled enhanced features. In the second stage, the obtained low-resolution enhanced features were fused with the corresponding high-resolution unenhanced features to achieve feature complementation across multiple resolutions. In the third stage, to address the position encoding difficulty caused by the large difference in the number of patch images, we performed position encoding based on multi-scale local neighborhoods and employed self-attention mechanism to obtain features with contextual information. The resulting contextual features were further combined with the local features extracted by the convolutional neural network. The evaluation results on clinically collected data showed that, compared with the best performance of traditional methods, the proposed network provided the best accuracy and area under curve (AUC), which were improved by 7.63% and 4.51%, respectively. These results have effectively validated the usefulness of this method in predicting gastric cancer recurrence.
Despite the documented health benefits of increased physical activity, there is limited research on behavioral programs designed to increase exercise in adolescents. Psychosocial characteristics, such as self-efficacy for exercise, social support for exercise from family and peers, and perceived benefits of and barriers to exercise, may predispose adolescents toward the adoption and maintenance of physical activity. This study will implement a multifaceted behavioral program specifically designed to increase bone strengthening physical activity by addressing many of the psychosocial factors relating to exercise.

Girls in this study will be enrolled in Project Fitness and Bone (FAB). The Project FAB intervention is delivered during a regular school class period 5 days per week for 10 months. One day per week is devoted to didactic presentations and/or discussion about reasons for being active, ways of overcoming barriers to being active, and strategies for maintaining an active lifestyle. The remaining four days are structured activity sessions, including a range of activities such as modified basketball, aerobic dance, and walking around a track. Primary outcome measures will include bone mass (measured via dual-energy x-ray absorptiometer \[DEXA\]) and serum and urinary measures of bone formation and resorption. Participants will be contacted by telephone 12 months after their final clinic visit to ascertain their activity level at that time.
Extended pelvic lymph node dissection (ePLND) is the most accurate staging tool to determine lymph node involvement in prostate cancer. As urologist perform this procedure more often now, thanks to the shift to more advanced and aggressive stages, the role of ePLND is expanding. The main complication of PLND is development of a collection of lymphatic fluid called a lymphocele. Lymphoceles can be associated with abdominal pain, lower urinary tract symptoms, bladder outlet obstruction, penile or scrotal edema, infection/sepsis, lower extremity swelling and deep vein thrombosis. They necessitate intervention in up to 10% of patients treated with RARP + ePLND which includes drainage or surgery. Radiologic incidence can be as high as around 50% of operated patients with unknown clinical relevance. Many interventions aimed at reducing the rate of lymphocele formation with limited success so far. Several retrospective studies suggested using peritoneal flap fixation technique which could direct the lymphatic fluid to the peritoneal cavity out of the pelvis and its ensure its reabsorption there. We hypothesize that peritoneal fixation can potentially lower the incidence of symptomatic and radiologic lymphocele formation. By preventing this potentially very dangerous complication, it could be very beneficial for a large group of patients suffering from aggressive localized prostate cancer who are scheduled for RARP + ePLND.

Our goal is to is to test this hypothesis in a randomized trial comparing the fixation technique to standard of care, i.e. no fixation.
BACKGROUND AND PURPOSE: Intraplaque hemorrhage (IPH) of carotid atherosclerosis is an important feature in complex lesions preceding acute stroke events. The current study aimed to determine the role played by IPH volume compared to that of carotid stenosis or maximal wall thickness in patients with carotid IPH.
MATERIALS AND METHODS: This retrospective study included 233 patients who presented with carotid IPH on vessel wall imaging (VWI). We divided the patients into symptomatic or asymptomatic groups based on territorial acute focal infarction. The IPH volume, degree of stenosis, and maximal wall thickness on VWI were analyzed.
RESULTS: Of the 233 included patients with carotid IPH, 51 (21.9 %) patients showed initial clinical symptoms and positive territorial findings on diffusion-weighted imaging (DWI). Moreover, 154 (66.1 %) patients had low-grade stenosis below 50 % (n = 19: symptomatic groups). Overall, carotid IPH volume, degree of stenosis, and maximal wall thickness were all significantly higher in the symptomatic groups (p = 0.001). The degree of stenosis, in all patients and especially in those with high-grade stenosis above 50 %, was significantly correlated with territorial acute focal infarction on multivariate analysis (p < 0.01). In patients with low-grade stenosis below 50 %, maximal wall thickness was associated with territorial acute focal infarction (p = 0.48).
CONCLUSION: Carotid IPH volume was a risk factor for territorial acute focal infarction. However, in patients with high-grade stenosis, the degree of stenosis was significantly linked to acute stroke. By contrast, in patients with low-grade stenosis, maximal wall thickness exhibited a significant association with acute stroke.
PURPOSE: A method of making a bathing agent containing substances purported to have health benefits such as herbal materials, seaweeds, vegetables, animals and mushrooms is provided. The product promotes metabolism and enhances disease resistance. CONSTITUTION: The bathing agent is prepared by fermenting and extracting a substance purported to have health benefits. The substance purported to have health benefits contains cereals, fruits or the like. The cereals contain rice, glutinous rice, barley, wheat, millet, oat, cowpea, buckwheat, sorghum, mung bean or the like are mixed with dietary fiber, vegetables or the like. The fruits and herbal materials contain plums, ginger, ginseng, red ginseng, grapes, pears, apples, persimmons, apricots, wild grapes, water melons, bananas or the like.
BACKGROUND: The effects of postoperative pancreatic fistula on survival rates remain controversial. The aim of the present study was to evaluate the influence of postoperative pancreatic fistula on overall survival and recurrence-free survival after upfront pancreatoduodenectomy for pancreatic ductal adenocarcinoma.
METHODS: Patients operated on between January 2007 and December 2017 at seven tertiary pancreatic centres for pancreatic ductal adenocarcinoma were included in the study. Postoperative pancreatic fistula was defined using the 2016 International Study Group on Pancreatic Surgery grading system. The impact of postoperative pancreatic fistula on overall survival, recurrence-free survival (excluding 90-day postoperative deaths) and corresponding risk factors were investigated by univariable and multivariable analyses. Comparisons between groups were made using the chi-squared or Fisher's exact test for categorical variables and the Mann-Whitney U test for continuous variables. Odds ratios were estimated with their 95% confidence intervals. Survival rates were calculated using the Kaplan-Meier method with their 95% confidence intervals.
RESULTS: A total of 819 patients were included between 2007 and 2017. Postoperative pancreatic fistula occurred in 14.4% (n = 118) of patients; of those, 7.8% (n = 64) and 6.6% (n = 54) accounted for grade B and grade C postoperative pancreatic fistula respectively. The 5-year overall survival was 37.0% in the non-postoperative pancreatic fistula group and 45.3% in the postoperative pancreatic fistula cohort (P = 0.127). Grade C postoperative pancreatic fistula (excluding 90-day postoperative deaths) was not a prognostic factor for overall survival. The 5-year recurrence-free survival was 26.0% for patients without postoperative pancreatic fistula and 43.7% for patients with postoperative pancreatic fistula (P = 0.003). Eight independent prognostic factors for recurrence-free survival were identified: age over 70 years, diabetes, moderate or poor tumour differentiation, T3/T4 tumour stage, lymph node positive status, resection margins R1, vascular emboli and perineural invasion.
CONCLUSION: This high-volume cohort showed that grade C postoperative pancreatic fistula, based on the 2016 International Study Group on Pancreatic Surgery grading system, does not impact overall or recurrence-free survival (excluding 90-day postoperative deaths).
Screening Meal Test performed and subject meets criteria for Postprandial Hypotension (PPH). At second Meal Test subject will receive a placebo and will take a placebo with the first bite of the next 3 meals.
The invention relates to blueberry-cherry wine brewed by mixed fermentation of blueberries and cherries and a preparation method thereof. The problems that the requirements on the pigment content of cherry raw materials are high and many cherry varieties cannot be used for brewing dry red wine in the background art are solved; meanwhile, the problem of poor taste caused by too high acid content of blueberry wine brewed by independently fermenting blueberries is solved. The invention relates to a processing method for freezing and storing two fruits of blueberry and cherry in different producing areas and mature periods to realize the purpose of brewing wine by mixing and fermenting the two fruits simultaneously. The method is favorable for leaching more pigments and fragrance components in the blueberry fruits, and has the effects of enriching the nutrition, flavor and health care function of the product. The other purpose is to obtain a new fruit wine product with unique flavor by using a novel brewing method, enrich the fruit wine market, and increase the purposes, storage and sale approaches of the blueberries and the cherries. The method comprises the steps of fermenting 10-50% of blueberries and 50-90% of cherries in a mixing manner, and brewing the blueberry-cherry dry red wine and the blueberry-cherry sweet red wine.
Subjects will undergo 21 study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will not be annouced to the controller and no adjustments to insulin and glucagon delivery will be made.
A modified factor VIIa is provided. The modified factor has increased amidolytic activity in the absence of T.F. and a higher affinity for T.F. when compared to the native factor VIIa but does not have substantially altered proteolytic activity when bound to T.F. Nucleic acid molecules that encode the factor, expression vectors that contain the nucleic acid molecules, cells that contain the nucleic acid molecules, and cells transformed with the expression vector are also provided. In a preferred embodiment, the modified factor is a human factor VIIa.
This is a multicenter (up to 35 centers), prospective, randomized double blind study. This study has a 2-arm design assessing the safety and effectiveness of the sirolimus-coated Bx VELOCITY stent to the uncoated Bx VELOCITY stent, both mounted on the Raptor Rapid Exchange Stent Delivery System. A total of 350 patients will be entered in the study and will be randomized on a 1:1 basis. Patients will be either randomized to the sirolimus coated or uncoated BX-VELOCITY stent. Patients will be followed at 30 days, 6, 9, and 12 months, and at 2, 3, 4, 5, 6, 7, and 8 years post-procedure, with all patients undergoing repeat angiography at 8 months. Medical resource use during the 5 years follow-up period will be collected and analyzed.