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

Although there is no information on the presence of valacyclovir in human milk, its metabolite, acyclovir, is present in human milk following oral administration of valacyclovir. Based on published data, a 500-mg maternal dose of valacyclovir twice daily would provide a breastfed child with an oral acyclovir dosage of approximately 0.6 mg/kg/day (see Data). There is no data on the effects of valacyclovir or acyclovir on the breastfed child or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for valacyclovir and any potential adverse effects on the breastfed child from valacyclovir or from the underlying maternal condition. 

Data

Following oral administration of a 500-mg dose of valacyclovir to 5 lactating women, peak acyclovir concentrations (Cmax) in breast milk ranged from 0.5 to 2.3 times (median 1.4) the corresponding maternal acyclovir serum concentrations. The acyclovir breast milk AUC ranged from 1.4 to 2.6 times (median 2.2) maternal serum AUC. A 500-mg maternal dose of valacyclovir twice daily would provide a breastfed child with an oral acyclovir dosage of approximately 0.6 mg/kg/day. Unchanged valacyclovir was not detected in maternal serum, breast milk or infant urine.
A device for retrograde hole opening through tissue has a member elongate on an axis with a cross section shaped to insert axially through external tissue. A distal and a proximal end on the member respectively enter the tissue during placement and remain outside the tissue for control. A tip at the distal end has a deployable tissue divider with one or more tissue parting elements and each has a splitter. The tissue parting elements are located within the cross sectional dimensions of the member in a storage position and are movable relative to the tip for placement in an exposed position relative to the tip when shifted from storage so that the splitter thereof splits tissue during retrograde extraction along the axis and contact with tissue. Linkage between the proximal end and the deployable tissue divider retains each of the tissue parting elements with its splitter exposed. The deployable tissue divider has an electrode for transmitting radio frequency energy received from the proximal end to at least each splitter. A return path completes the circuit to provide an electrosurgical effect during the retrograde extraction. A method of placing the device for retrograde hole opening aligns the axis of the elongate member normal to the outside abdominal wall of the body, places the distal end through the tissue and leaving the proximal end outside of the tissue, deploys the tissue divider having one or more tissue parting elements that are first located in a storage position within the cross section to an exposed position with the splitter of each element positioned to split tissue, moves each element axially while exposed and fixed and splits tissue during extraction from the body cavity.
NEW MATERIAL:A naphthopyran derivative expressed by the formula. USE:An agricultural and horticultural germicide and a medicinal antimicrobial agent capable of exhibiting excellent antimicrobial action on molds such as Phycomycetes, Ascomycetes, Basidiomycetes and imperfect fungi and bacteria and effective against blasts, etc., of rice plant. PREPARATION:Stem and leaf parts of Rhinacanthus nasutus are extracted with an organic solvent such as an alcoholic, an ester-based, an ethereal, an acetonic or a nitrile-based solvent according to a conventional method. Separation and purification are carried out to afford the compound expressed by the formula. The Rhinacanthus nasutus is a shrub living in the southern part of China and India and contains the naphthopyran-based substance, expressed by the formula and capable of exhibiting powerful antimicrobial activity. The aforementioned derivative can be prepared into the form of a dust, a wettable powder, an emulsion and a granule as an agricultural and horticultural germicide and the form of oral solid pharmaceutical, a suppository, a liniment, an ointment, an injection, a syrup, etc., as a medicinal antimicrobial agent.
CABG was performed under normothermic (36-37°C) cardiopulmonary bypass (CPB). All components of the circuits were coated with phosphorylcholine inert surface (PHISIO, Sorin®). The pump manufacturer is Maquet® for the roller pumps.1.5 cm of ITA distality was sampled before blood flow interruption into the graft and before starting CPB (Time 1) and another segment (1.5 cm) before the last coronary anastomosis during aortic cross clamping (Time 2) (Figure 1). Each arterial segment was cut into three parts: a fresh part for arterial myography bathed and stored in a 50 ml organ bath containing a physiological salt solution (PSS). The other two parts were cooled in liquid nitrogen and stored at -80°C for immunohistochemistry and RT-PCR analysis.
Jadenu is commercially available as tablets and will be provided by the patient with their ongoing prescription. Dosing will be at equivalent (mg for mg) doses of DST-0509 or Jadenu. Jadenu is taken once daily with or without a light meal. However, Jadenu can be administered according to the patient's current prescription regimen. The first dose will be taken at Visit 3 (Day 1) and the final dose will be taken at Visit 10 (Day 63).
UNLABELLED: A recent estimate indicates that up to 23.7 million Americans suffer from long COVID, and approximately one million workers may be out of the workforce each day due to associated symptoms, leading to a USD 50 billion annual loss of salary. Post-COVID (Long COVID) neurologic symptoms are due to the initial robust replication of SARS-CoV-2 in the nasal neuroepithelial cells, leading to inflammation of the olfactory epithelium (OE) and the central nervous system (CNS), and the OE becoming a persistent infection site. Previously, our group showed that Epigallocatechin-3-gallate-palmitate (EC16) nanoformulations possess strong antiviral activity against human coronavirus, suggesting this green tea-derived compound in nanoparticle formulations could be developed as an intranasally delivered new drug to eliminate the persistent SARS-CoV-2 infection, leading to restored olfactory function and reduced inflammation in the CNS. The objective of the current study was to determine the compatibility of the nanoformulations with human nasal primary epithelial cells (HNpECs).
METHODS: Nanoparticle size was measured using the ZetaView Nanoparticle Tracking Analysis (NTA) system; contact antiviral activity was determined by TCID50 assay for cytopathic effect on MRC-5 cells; post-infection inhibition activity was determined in HNpECs; and cytotoxicity for these cells was determined using an MTT assay. The rapid inactivation of OC43 (a β-coronavirus) and 229E (α-coronavirus) viruses was further characterized by transmission electron microscopy.
RESULTS: A saline-based nanoformulation containing 0.1% w/v EC16 was able to inactivate 99.9999% β-coronavirus OC43 on direct contact within 1 min. After a 10-min incubation of infected HNpECs with a formulation containing drug-grade EC16 (EGCG-4' mono-palmitate or EC16m), OC43 viral replication was inhibited by 99%. In addition, all nanoformulations tested for their effect on cell viability were comparable to normal saline, a regularly used nasal irrigation solution. A 1-min incubation of an EC16 nanoformulation with either OC43 or 229E showed an altered viral structure.
CONCLUSION: Nanoformulations containing EC16 showed properties compatible with nasal application to rapidly inactivate SARS-CoV-2 residing in the olfactory mucosa and to reduce inflammation in the CNS, pending additional formulation and safety studies.
The present invention discloses a tripterygium wilfordii and an improving technology for attenuation and synergy of extractives of the tripterygium wilfordii. The technology (1) comprises the following steps: the traditional Chinese medicine of tripterygium wilfordii is directly dipped by an acid solution, and triptolide in the tripterygium wilfordii is converted into tripchlorolide (II). Or the technology (2) comprises the following steps: the tripterygium wilfordii is produced into extractum; then, the tripterygium wilfordii or the extractum is purified, treated by acid or dipped by the acid solution so as to prepare the tripchlorolide (II), and the detailed technology is shown in a specification. The improving technology has the advantages that tripchlorolide (II) with low toxicity is prepared by the change of a chemical structure, and thus, medicine resources with large toxicity of roots, barks and leaves of the tripterygium wilfordii are perfectly utilized. The improving technology makes the basis of the development of the tripterygium wilfordii and correlative agents and has wide application prospect. Meanwhile, the improving technology has the advantages of simple operation, low cost and easy popularization. The tripterygium wilfordii is used for treating rheumatoid arthritis, chronic nephritis, hepatitis, thrombopenic purpura and various kinds of dermatosis arthritis. At present, the research on the aspects of fertility resistance, tumour resistance, body rejection resistance after organ transplantation and the like obtains large development.
OBJECTIVE: Intrathecal baclofen (ITB) is an effective treatment for refractory hypertonia in children. ITB has long been effective for the treatment of spasticity, and indications have naturally evolved to include dystonia and mixed pediatric movement disorders (PMDs). The established uses for ITB trials are insurance prerequisite, mixed tone, and family request. Despite agreement for ITB therapy by a multidisciplinary group of subspecialists in a complex PMD program, insurance companies often require an ITB trial be performed. A longitudinal cohort was identified to determine the safety and efficacy of ITB trials and to determine the utility of test dosing in this population.
METHODS: Retrospective data analysis was performed for patients with hypertonia who underwent ITB bolus trials at the authors' institution between 2021 and 2023. Nonmodifiable risk factors and clinical variables were collected.
RESULTS: Thirty-one patients (11 female) underwent 32 ITB trials. Of these patients, 67.7% had a diagnosis of mixed hypertonia, 32.3% pure spasticity, and 9.1% secondary dystonia. The mean age at test dose was 12.8 years, and 58.1% of patients were born premature. The mode Gross Motor Function Classification System score was 5. The mean difference in Barry-Albright Dystonia Scale (BADS) scores was -7.33 points (p = 0.01) at 2.5 hours postoperatively. The mean difference in upper-extremity modified Ashworth Scale (mAS) scores was -5.36 points (p = 0.003), and that for lower-extremity mAS scores was -6.61 (p < 0.001). In total, 21.9% of patients developed a post-dural puncture headache. Conversion to a permanent baclofen pump was performed in 22/32 (68.8%) patients. Of those who did not pursue pump placement, 1 patient had high surgical risk, 1 had an ineffective response, 1 had a bad reaction to the test dose and cited both regression and increased discomfort, and 2 declined despite an effective trial owing to family preferences.
CONCLUSIONS: ITB trials require hospitalization in some form and carry risks of procedural complications. The decision to pursue a trial should be made on a case-by-case basis by clinicians and should not be determined by insurance companies. The complication rate of ITB trials is high, and a test dose is unnecessary in this fragile population.
The investigators plan to perform a prospective study on all women seen in our RACPC with no previous history of CAD and intermediate pre-test probability of CAD as determined by National Institute for Health and Care Excellence (NICE) guidelines, who require a functional test as part of their assessment. All patients that meet the inclusion criteria and do not meet any of the exclusion criteria will be approached for consent to the study.

Patients who can perform greater than 5 metabolic equivalents (METS) on the Duke Activity Status Index (DASI) questionaire will be randomised between undergoing an Exercise ECG (Ex-ECG) or Exercise Stress Echo (ESE). The DASI is a 12-item questionnaire that estimates self-reported physical work capacity and is converted to an estimate of peak metabolic equivalents. Patients who do not meet this criteria, will undergo a pharmacological stress echocardiogram using Dobutamine (DSE), including Myocardial Contrast Echocardiography (MCE). Investigations will continue to be performed as per standard clinical departmental protocols as described below. In addition, all patients will undergo carotid ultrasonography. The techniques used are described for completeness as they are all well-established in clinical practice.
Patients receive HAI therapy as in group 1. Patients also receive irinotecan hydrochloride IV over 30 minutes and leucovorin calcium IV over 30 minutes on days 1 and 15 and fluorouracil IV continuously over 48 hours on days 1, 2, 15, and 16. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Quazepam Tablet is a central nervous system (CNS) depressant and can impair daytime function in some patients even when used as prescribed. Prescribers should monitor for excess depressant effects, but impairment can occur in the absence of subjective symptoms, and may not be reliably detected by ordinary clinical exam (i.e. less than formal psychomotor testing). While pharmacodynamics tolerance or adaptation to some adverse depressant effects of Quazepam Tablets may develop, patients using Quazepam Tablets should be cautioned against driving or engaging in other hazardous activities or activities requiring complete mental alertness.

Additive effects occur with concomitant use of other CNS depressants (e.g., other benzodiazepines, opioids, tricyclic antidepressants, alcohol), including daytime use. Downward dose adjustment of Quazepam Tablets and concomitant CNS depressants should be considered. The potential for adverse drug interactions continues for several days following discontinuation of Quazepam Tablets, until serum levels of both active parent drug and psychoactive metabolites decline.

Use of Quazepam Tablets with other sedative-hypnotics is not recommended. Alcohol generally should not be used during treatment with Quazepam Tablets. The risk of next-day psychomotor impairment is increased if Quazepam Tablets is taken with less than a full night of sleep remaining (7 to 8 hours); if higher than the recommended dose is taken; if co-administered with other CNS depressants [see Dosage and Administration ( 2.1)] . 

Because Quazepam Tablets can cause drowsiness and a decreased level of consciousness, patients particularly the elderly, are at higher risk of falls.
The invention discloses a sialic acid bonded with antigens and application of the sialic acid and relates to sialic acids. The sialic acid bonded with the antigens is composed of 2,4-dinitrobenzene and a sialic acid body. The molecular formula is C17H22N4O12. The molecular weight is 474.1234. The sialic acid bonded with the antigens can be applied to preparation of drugs for immunity prevention and treatment of tumors. After being absorbed by tumor cells, the sialic acid bonded with the antigens is expressed on the surfaces of the tumor cells in a covalency mode through a metabolic pathway. DNP-Sia is intravenously injected to a mouse body having subcutaneous tumors and is fast and effectively expressed on the surfaces of the tumor cells of solid tumors. The tumor cells where the DNP-Sia is expressed can effectively collect DNP antibodies or T cells with cytotoxicity and are combined with the DNP antibodies or the T cells with cytotoxicity, and therefore the tumor cells can be dead. Relevant antigens on the surfaces of the tumors are expanded, and growth of the tumors can be effectively regulated and controlled.
Long-term studies were conducted in hamsters and mice with roflumilast to evaluate its carcinogenic potential. In 2-year oral gavage carcinogenicity studies, roflumilast treatment resulted in dose-related, statistically significant increases in the incidence of undifferentiated carcinomas of nasal epithelium in hamsters at ≥ 8 mg/kg/day (approximately 11 times the MRHD based on summed AUCs of roflumilast and its metabolites). The tumorigenicity of roflumilast appears to be attributed to a reactive metabolite of 4-amino-3,5-dichloro-pyridine N-oxide (ADCP N-oxide). No evidence of tumorigenicity was observed in mice at roflumilast oral doses up to 12 and 18 mg/kg/day in females and males, respectively (approximately 10 and 15 times the MRHD, respectively, based on summed AUCs of roflumilast and its metabolites).

Roflumilast tested positive in an in vivo mouse micronucleus test, but negative in the following assays: Ames test for bacterial gene mutation, in vitro chromosome aberration assay in human lymphocytes, in vitro HPRT test with V79 cells, an in vitro micronucleus test with V79 cells, DNA adduct formation assay in rat nasal mucosa, liver and testes, and in vivo mouse bone marrow chromosome aberration assay. Roflumilast N-oxide was negative in the Ames test and in vitro micronucleus test with V79 cells.

In a human spermatogenesis study, roflumilast 500 mcg had no effects on semen parameters or reproductive hormones during the 3-month treatment period and the following 3-month off-treatment period. In a fertility study, roflumilast decreased fertility rates in male rats at 1.8 mg/kg/day (approximately 29 times the MRHD on a mg/m2 basis). The male rats also showed increases in the incidence of tubular atrophy, degeneration in the testis and spermiogenic granuloma in the epididymides. No effect on rat fertility rate or male reproductive organ morphology was observed at 0.6 mg/kg/day (approximately 10 times the MRHD on a mg/m2 basis). In a female fertility study, no effect on fertility was observed up to the highest roflumilast dose of 1.5 mg/kg/day in rats (approximately 24 times the MRHD on a mg/m2 basis).
To evaluate the sleep quality and fatigue levels in children with familial Mediterranean fever (FMF) in comparison to healthy children. The Pediatric Quality of Life Multidimensional Fatigue Scale (PedsQL-MFS) and the Pittsburgh Sleep Quality Index (PSQI) were the instruments utilized to assess fatigue and sleep quality in children with FMF and controls, respectively. Spearman's rank coefficient was decisive in determining the association between patient-reported outcome measures and disease-related features. Two hundred twenty-five (59.3% female) patients and 182 (51.6% female) healthy counterparts were enrolled in the study. In PSQI, where high scores indicate sleep disturbance, the median score was significantly higher in the patient group (5; 3-6) than the control group (3; 2-4) (p < 0.001). PEDsQL-MFS demonstrated significantly lower fatigue levels in the control group than patients (p = 0.01). The level of fatigue in the patient group was found to increase in correlation with sleep problems (r: - 0.750, p < 0.001). Additionally, a high correlation was present between the PSQI/PedsQL-MFS scores and the number of attacks in the last year (r: - 0.645, p < 0.001/r: 0.721, p < 0.001, respectively). There was no difference in terms of fatigue and sleep disorders between mutations (homozygous, heterozygous, or compound heterozygous) in the MEFV gene (p > 0.05).    Conclusion: High disease activity has a significant negative impact on the sleep quality and fatigue levels of patients with FMF. This study emphasizes the importance of assessing fatigue and sleep quality with objective outcome tools periodically in FMF patients throughout the disease course. What is Known: • Fatigue is a common matter that often accompanies rheumatic diseases and causes disability. • Chronic rheumatic diseases often experience poor sleep quality. What is New: • In high correlation with the disease severity of familial Mediterranean fever, sleep quality decreases and fatigue level increases significantly. • In familial Mediterranean fever patients, a negative correlation is present between age and the general fatigue and sleep/rest related fatigue scores (low scores indicating greater fatigue) and sleep quality is poorer in the adolescent age group.
A retrospective analysis of disease histories for the period from 2014 to 2021 was carried out. Data collection was carried out at all stages of treatment: medical and nursing brigade, military mobile hospital, military medical clinical center, during rehabilitation, within 12 months of the injury.
Participants will first receive one tablet \[500 milligram (mg) of paracetamol\] of Tylenol® Caplets, orally with 250 mL of water at room temperature, in a single dose, under minimum 10 h fasting. After a washout period of 72 h, they then will receive one tablet (500 mg of paracetamol) of Mejoral® 500 tablets, orally with 250 mL of water at room temperature, in a single dose, under minimum 10 h fasting.
Primary pulmonary involvement is an important aspect that leads to morbidity and mortality in adult patients with rheumatoid arthritis \[1,2\] but is not as frequent in patients with juvenile idiopathic arthritis (JIA), (prevalence; 4-8%) \[3\]. However, a body of evidence indicates that respiratory functions are affected in more than 50% of all children with JIA, even in those without radiological involvement \[1,2,4\]. Previous studies comparing children with JIA to their healthy peers showed that forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), peak flow rate (PEF), and carbon monoxide diffusion capacity (DLCO) are decreased and the maximum inspiratory pressure (PImax) and maximum expiratory pressures (PEmax), which are used to assess respiratory muscle strength, are significantly lower \[2,4\]. In addition, it has been reported that disease-modifying drugs (DMARDs) and non-steroidal anti-inflammatory drugs (NSAIDs), which are frequently used in the treatment of patients with JIA may cause a decrement in respiratory functions \[5\]. It has been suggested that the decrease in the pulmonary functions in patients with JIA without radiological involvement of the lung parenchyma or thorax may be caused by the weakness of inspiratory and expiratory muscles \[2\]. Moreover, symptoms and signs such as chronic joint pain and stiffness, synovitis, and deformity seen in children with JIA may limit movement, leading to an inactive lifestyle. Evidence suggests that children with JIA have lower levels of physical activity than age-matched controls \[6,7\]. This inactive lifestyle accompanying the disease process; may cause decline in aerobic and anaerobic capacity, peripheral muscle strength and quality of life \[8,9\].

Inspiratory muscle training (IMT) is defined as a technique that aims to improve the function and strength of respiratory muscles through performing exercises with a specialized device \[10,11\]. There is evidence that the IMT method improves functional status and increases respiratory muscle strength, respiratory volumes, and aerobic exercise capacity in adult rheumatologic patients \[12,13\]. IMT seems to increase perfusion and muscle metabolism in both respiratory and extremity muscles, provide muscle fiber type conversion, create neural plasticity at respiratory synapses in the central nervous system, and modulate dyspnea in different populations \[14\]. Despite this, the effectiveness of IMT has not been investigated in patients with JIA.