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

There are no studies with the use of solifenacin succinate in pregnant women to inform a drug-associated risk of major birth defects, miscarriages, or adverse maternal or fetal outcomes. No adverse developmental outcomes were observed in animal reproduction studies with oral administration of solifenacin succinate to pregnant mice during the period of organogenesis at a dose resulting in 1.2 times the systemic exposure at the maximum recommended human dose (MRHD) of 10 mg/day. However, administration of doses 3.6 times and greater than the MRHD during organogenesis produced maternal toxicity in the pregnant mice and resulted in developmental toxicity and reduced fetal body weights in offspring [see Data]. 

In the U.S. general population, the estimated background risk of major birth defects or miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. 

Data

Animal Data

Oral administration of 14C-solifenacin succinate to pregnant mice resulted in the recovery of radiolabel in the fetus indicating that solifenacin-related product can cross the placental barrier. In pregnant mice, administration of solifenacin succinate at a dose of 250 mg/kg/day (7.9 times the systemic exposure at the MRHD of 10 mg), resulted in an increased incidence of cleft palate and increased maternal lethality. Administration of solifenacin succinate to pregnant mice during organogenesis at greater than or equal to 3.6 times (100 mg/kg/day and greater) the systemic exposure at the MRHD, resulted in reduced fetal body weights and reduced maternal body weight gain. No embryo-fetal toxicity or teratogenicity was observed in fetuses from pregnant mice treated with solifenacin succinate at a dose of 30 mg/kg/day (1.2 times the systemic exposure at the MRHD). Administration of solifenacin succinate to pregnant rats and rabbits at a dose of 50 mg/kg/day (< 1 times and 1.8 times the systemic exposure at the MRHD, respectively), resulted in no findings of embryo-fetal toxicity. Oral pre- and post-natal administration of solifenacin succinate at 100 mg/kg/day (3.6 times the systemic exposure at the MRHD) during the period of organogenesis through weaning, resulted in reduced peripartum and postnatal survival, reduced body weight gain by the pups, and delayed physical development (eye opening and vaginal patency). An increase in the percentage of male offspring was also observed in litters from offspring (F2 generation) exposed to maternal doses of 250 mg/kg/day. There were no effects on natural delivery in mice treated with 1.2 times (30 mg/kg/day) the expected systemic exposure at the MRHD.
Anhedonia is characterized by diminished reward processing, which may be explained in part by dampening appraisals, or thoughts that blunt positive emotions. Experiential processing, or attending to sensory and bodily experience, may curb dampening appraisals, as compared to analytical processing, or conceptually thinking about an event. In this study, 96 participants with elevated anhedonia completed writing tasks, in which they recalled positive autobiographical memories. Participants recalled the first memory as they naturally would to assess spontaneous use of processing mode and were then randomized to recall the second positive memory using either experiential, analytical, or control instructions. Both spontaneous and instructed experiential processing were associated with greater positive affect and less dampening compared to analytical processing. Clinical implications include savoring pleasant sensations to reduce dampening and enhance positive affect in anhedonia.
Systems, apparatus, and method of monitoring a position of a joint. An inertial monitoring unit (48A) is configured to be coupled to a portion of a patient, such as a thigh (26). Another inertial monitoring unit (48B) is configured to be attached to another portion of the patient, such as a shank (24), that is connected to the other portion by a joint, such as a joint (28). The inertial monitoring units (48A, 48B) detect motion of their respective portions of the patient and transmit data indicative of this motion. These transmissions may be received by a computer (54) and used to determine an orientation of the joint (28). The inertial monitoring units (48A, 48B) may also be coupled to vibration detection modules (50) and/or ultrasound modules (52) that provide additional data regarding a condition of the joint (28).
Isolated extracellular matrix-binding proteins, designated ClfB, SdrC, SdrD and SdrE, and their corresponding amino acid and nucleic acid sequences and motifs are described. The proteins, peptides, fragments thereof or antigenic portions thereof are useful for the prevention, inhibition, treatment and diagnosis of  S. aureus  infection and as scientific research tools. Further, antibodies or antibody fragments to the proteins, peptides, fragments thereof or antigenic portions thereof are also useful for the prevention, inhibition, treatment and diagnosis of  S. aureus  infection. In particular, the proteins or antibodies thereof may be administered to wounds or used to coat biomaterials to act as blocking agents to prevent or inhibit the binding of  S. aureus  to wounds or biomaterials. 
     ClfB is a cell-wall associated protein having a predicted molecular weight of approximately 88 kDa and an apparent molecular weight of approximately 124 kDa, which binds both soluble and immobilized fibrinogen. ClfB binds both the alpha and beta chains of fibrinogen and acts as a clumping factor. SdrC, SdrD and SdrE are cell-wall associated proteins that exhibit cation-dependent ligand binding to the extracellular matrix. It has been discovered that in the A region of SdrC, SdrD, SdrE, ClfA and ClfB, there is a highly conserved amino acid sequence that can be used to derive a consensus motif of TYTFTDYVD.
The aim of this study was to investigate the relationships between physical activity level and demographic factors, motor function, cognitive function, functional status, balance and quality of life in patients with chronic stroke and to compare physical activity levels with healthy individuals in the same population. It is a fact that the physical activity levels of individuals decrease significantly after stroke. However, there is no study examining to what extent the physical activity is affected and the factors related to the decrease in the level of physical activity. The primary aim of stroke rehabilitation is to recognize and prevent complications, to minimize disturbances, to maximize functions. Secondary objectives; to prevent stroke recurrence. Physical activity has been shown to reduce the risk of stroke, stroke severity and other consequences. The risk of a reduction in physical capacity occurs over time and it is assumed that normal physical activity can prevent recurrent stroke. Therefore, it is necessary to continuously assess physical activity levels after stroke. In order to increase physical activity levels, it is important to identify people with low levels of physical activity and to understand the factors that may be associated. Therefore, in this study, we aimed to provide a comprehensive analysis by including most of the factors that may be related to physical activity in patients with stroke. In this study, unlike previous studies on physical activity in stroke, the relationships between physical activity and factors such as motor function, quality of life and cognitive skills as well as balance measurements and walking speed parameters which will be obtained from computerised posturography will be examined. In previous studies Physical Activity Scale for Elderly (PASE) questionnaire or the accelerometer device are used for the measurement of physical activity level. In this study, both of these tools will be used and the correlation between these two assessment tools will be demonstrated. In this study, patients with stroke will be evaluated by using PASE scale and accelerometer results (accelerometer will be held from Monday to Friday) for physical activity and Mini Mental test for cognitive function, Fugl Meyer Scale for motor function, Berg Balance Test and computerized posturography analysis for balance, Barthel Index for daily activities, Stroke Impact Scale for quality of life, Brunnstrom stage for motor recovery status. Each of the tests lasts about 5-10 minutes. Healthy control group will also be assessed via accelerometer and PASE questionnaire for physical activity and computerized posturography for balance.

With this study, physical activity which is protective for recurrent stroke, will be evaluated comprehensively and factors associated with physical activity will be revealed. Thus, in order to increase the physical activity, it will be concluded which factor should be treated or evaluated, and these results will be very helpful for further studies.
To ensure the safe use of oral anticancer drugs, oncology pharmacy consultations (OPCs) have been established in France. Their goal is to provide the patient with the means to identify, prevent and limit adverse effects and to know who to refer to in case of a serious adverse effect, perform a pharmaceutical analysis of the prescription, and participate in the improvement and evaluation of overall compliance. OPCs are conditioned by the needs, expectations, and involvement of the patients in their care. In healthcare, patients are increasingly encouraged to play an active role in the knowledge and management of their health, express their concerns and preferences, and participate in medical decisions. Thus, it is essential to elicit their preferences. The discrete-choice experiment (DCE) is the validated and recommended method of the International Society for Pharmacoeconomics and Outcomes Research for such a task.
OBJECTIVES: Tegmen and superior semicircular canal defects have been well studied, yet the factors contributing to their onset and progression are widely debated. The clinical utility of intraoperative intracranial pressure measurements has yet to be tested. This report aims to use intraoperative opening pressure and concurrent superior semicircular canal dehiscence (SSCD) to analyze factors influencing disease course and clinical outcomes in patients with tegmen dehiscence.
METHODS: A retrospective analysis of 61 patients who underwent tegmen defect repair was performed. Multiple variables of interest including body mass index (BMI), presence of SSCD, presence of dural venous sinus stenosis, opening pressure, and acetazolamide therapy use were recorded. The cohort was divided into those with or without concurrent SSCD and those presenting with or without cerebrospinal fluid (CSF) leak for analysis.
RESULTS: A linear relationship between opening pressure and BMI (p = 0.009) was noted; however, intraoperative opening pressure was not associated with disease outcome. Concurrent SSCD was present in 25 % of patients, while 62 % presented with CSF leak. The concurrent SSCD group exhibited higher opening pressure, higher likelihood of having dural sinus stenosis, and higher likelihood of being discharged on acetazolamide. The CSF leak group had higher likelihood of obstructive sleep apnea and persistent symptoms.
CONCLUSIONS: In patients undergoing tegmen defect repair, concurrent SSCD suggests increased disease severity. The presence of preoperative CSF leak predicts persistent symptoms following repair. BMI is linearly correlated with intracranial pressure in these patients.
PURPOSE: To obtain a stable two agent-mixing type cosmetic used by mixing the first agent with the second one just before used, and increasing the viscosity, when the agents are mixed and used. CONSTITUTION: The first agent contains an oxidation dyestuff as a main agent and other components such as an alkali agent, and has a pH of >=5. The second agent contains an oxidizing agent such as hydrogen peroxide and 0.005-5wt.% of a carboxyvinylpolymer, and has a pH of <=5. The first and second agents are mixed with each other so as to give a pH of >=5. The main agent for the cosmetic may be added to one or both of the first agent and the second agent. Since the pH of the second agent is <=5 before the use, the second agent is low in viscosity, does not adhere to the inner wall of the container, and can therefore effectively be used. When the first and second agents are mixed with each other to give the pH of >=5, the viscosity of the mixture increases due to the increased viscosity of the carboxyvinylpolymer.  Thereby, the mixture easily stays at an application point on a human body, and does not limit the freedom of treatments. This two agent-mixing type cosmetic is used for a hair- dyeing agent, a hair-decoloring agent, a permanent wave agent, an epilation agent, etc.
In a randomized double-blind, crossover design, 12 adult volunteers with G6PD deficiency of both sexes will be supplemented with either 600 mg of alpha-lipoic acid (experimental condition - EC) or placebo (control condition - CC) every day for 4 weeks. Before intervention, all participants will be informed about the study protocol, fill a medical history questionnaire and sign an informed consent form. Moreover, measurements of anthropometric characteristics and physiological parameters, as well as a VO2max test will be performed.

Participants will perform 4 trials of exercise (70% VO2max for 45min and 90% till exhaustion) before and after each condition. Blood samples will be collected before, immediately after and 1 hour after exercise. Moreover, measurements of anthropometric characteristics and physiological parameters will be performed before and after each condition. There will be a washout period of at 4 weeks between conditions.
Background: Alcohol dependence is one of the leading causes of disability worldwide. Despite the availability of efficacious treatments less than 20% of individuals with alcohol dependence are actively engaged in treatment. Within the VA system systematic screening was implemented to increase the identification of patients with both abuse and dependence. However, there continues to be a marked discrepancy in the care offered or accessed among those identified with alcohol dependence. Existing treatment guidelines suggest that all persons with dependence receive care in specialty addiction treatment. Data from our center indicate that among those individuals screened in primary care who have AUDIT - C scores of \>7, only 30% are formally evaluated with 50% receiving only brief advice and 20% having no evidence of assessment or referral. Of those assessed and referred to specialty care only 60% attend an initial visit and only 33% meet the EPRP performance measure of 2 visits per month for 90 days. This disparity in treatment access exists even though Veterans self report a desire to cut down and readiness to change drinking behaviors. (VA ACQUIP) and a willingness to consider pharmacotherapy.

Aims: Available evidence suggests that primary care may be a key component in the identification of alcohol dependent patients, delivery of initial interventions, and to the success of addiction treatment. Indeed, the vast majority of screening and new case identification occurs within primary care. The primary aims of this proposal are to test the effectiveness of a primary care based Alcohol Care Management (ACM) program and to evaluate the barriers and facilitators to accessing and engaging individuals into treatment. The ACM program uses a Behavioral Health Specialist to deliver care focused on the use of pharmacotherapy in combination with psychosocial support (Medication Management). This model may overcome barriers to care such as frequent intensive visit schedules often required in specialty settings, stigma associated with specialty care or group therapy approaches, access to specialty care in remote areas, and the current focus on a 12 step model of treatment. Secondary aims are to establish the acceptability of primary care based treatments and defining treatment modifiers such as age, barriers, co-occurring depression, and pharmacogenetic response.
Part A vaccinees in the "low dose" arm will receive the lower dosing (20 μg FMP014 per 0.5 mL ALFQ) approximately 2 weeks prior to each vaccination. Vaccination to be delivered on 0,1,2 month.
PROBLEM TO BE SOLVED: To obtain a preparation in such a dosage form as to extremely raise an inhibitory action on melanin production by formulating a substance having an inhibitory action on melanin production with an alkyl modified carboxyvinyl polymer and/or its salt. SOLUTION: This bleaching preparation comprises (A) a substance having an inhibitory action on melanin production (preferably hydroxyquinone) and (B) an alkyl modified carboxyvinyl polymer and/or its salt. Preferably the component B is wholly or partially neutralized with a basic substance such as an alkali metal salt or the like is used in a form containing a physiologically acceptable salt. Preferably the formulated amount of the component A based on the total of the cosmetic is 0.05-5 wt.% and that of the component B is 0.05-1 wt.%. Further addition of 10-30 wt.% of a polyhydric alcohol can preferably raise an inhibitory action on melanin production. Preferably >=30 wt.% of the polyhydric alcohol is 1,3-butanediol.
BACKGROUND: When there is limited access to primary care or end-of-life services for patients with chronic diseases, caregivers often need to bring their loved ones to emergency departments (EDs) to solve or control distressing physical and psychosocial-spiritual problems. There is limited literature about the experiences of primary caregivers of patients with nononcologic chronic diseases who are at the end of life and are evaluated in EDs in Latin America.
METHODS: We conducted in-depth interviews with primary caregivers of adult patients with advanced and terminal chronic nononcologic diseases who were evaluated in the ED of a hospital in Lima, Peru. This qualitative study employed a phenomenological approach. Themes, categories, codes, and quotes were analyzed using ATLAS.ti 9.1.4.
RESULTS: Twelve primary caregivers, aged 38 to 76 years old, mostly female immediate family members (daughter or wife), participated. They described their experiences in the ED, including feelings of despair and anguish due to prolonged waiting times, insufficient resources, incomplete information regarding the patient's problems, and "insensitive" treatment by the staff. Some also expressed gratitude for "saving patient's lives." They also experienced deficiencies in home care follow-up and patient transfers, which worsened during the COVID-19 pandemic; many times they felt that "they were ignored." When caring for patients at home, caregivers felt sad, helpless, and frustrated as they observed patients' progressive deterioration. As patients approached death, caregivers expressed that they tried to "give them all the love" and to have them present for as long as possible, although at the same time caregivers did not want patients to continue to suffer and hoped for "a better place" after this life. Caregivers found their faith to be a source of strength as they continued to care for and be with their loved one until the end.
CONCLUSION: Caregivers reported "traumatic" and "shocking" experiences during ED care, as well as conflict between wanting the patient's suffering to end and wanting to prolong their lives. They also expressed feelings of gratitude, resignation, love, faith, and hope.
The invention provides a helicobacter pylori vaccine recombinant protein antigen NC-1, and the amino acid sequence is shown as SEQ ID NO. 1. The invention also provides a nucleic acid which codes for the recombinant protein antigen NC-1 of the helicobacter pylori vaccine according to claim 1. The nucleic acid sequence is shown as SEQ ID NO. 2. The helicobacter pylori vaccine recombinant protein antigen NC-1 provided by the invention has the advantages of soluble expression, easy purification, high purity, simple preparation method and the like, has obvious economic benefit, and animal experiments prove that the helicobacter pylori vaccine recombinant protein antigen NC-1 can effectively stimulate organisms to generate immune responses and has good immune protection effect, and can be used as a vaccine candidate component for preventing helicobacter pylori infection.
The invention discloses a neuroprotective active polypeptide and application thereof. The amino acid sequence of the polypeptide is shown as SEQ ID NO. 1. The application of the polypeptide is the application in preparing a medicament for treating cerebral nerve injury and sequelae thereof. The invention obtains the polypeptide OL-FS13 with nerve protection activity from the skin secretion of rana grahami, the polypeptide has simple structure, and the polypeptide has stronger nerve injury repair promoting activity under low dosage (10 mug/kg in vivo and 100 pM in vitro) in vivo and in vitro. Compared with neuroprotective peptide OM-LV20, the mature peptide sequence of the polypeptide OL-FS13 provided by the invention is shorter, so that the synthesis cost is lower. In addition, unlike OM-LV20, OM-LV20 reduces cerebral ischemia reperfusion rat nerve injury through prophylactic administration, and the OL-FS13 of the invention has the effect of repairing after reperfusion injury, has higher clinical application value, and provides a new direction for developing neuroprotective medicines.
The invention discloses a hydrochloric acid vilazodone quick-release tablet and a preparation method thereof. The hydrochloric acid vilazodone quick-release tablet comprises the follow components by mass: 2-12% of hydrochloric acid vilazodone, 28-45% of lactose, 40-60% of microcrystalline cellulose, 0.5-3% of lubricants and 1-5% of coating materials. The lubricants include magnesium stearate and colloidal condition silica or one of the magnesium stearate and the colloidal condition silica. The hydrochloric acid vilazodone quick-release tablet is prepared through the following steps: evenly mixing the hydrochloric acid vilazodone, the lactose, the microcrystalline cellulose and the lubricants according to proportion of a formula, detecting whether content uniformity is qualified, and pressing the mixture into tablets when the content uniformity is qualified. The hydrochloric acid vilazodone quick-release tablet has special requirements for grain size of the hydrochloric acid vilazodone, and the preparation process saves time and labor, reduces energy consumption and improves production efficiency. Disintegration speed of medicines is fastened, the dissolving-out time is obviously less than that of a prescription which has no limitation on the grain size of the hydrochloric acid vilazodone, and simultaneously the process which directly performs mixing tabletting greatly improves stability of the medicines in preparations.