anthonyyazdaniml/gliner-biomed-curated-corpus huggingface dataset:
The safety and efficacy of QUZYTTIR have been established in patients 6 months to 17 years of age. The efficacy of QUZYTTIR for the treatment of acute urticaria down to 6 months of age is based on extrapolation of the efficacy of QUZYTTIR in adults with acute urticaria [See Clinical Studies (14)] and supported by pharmacokinetic data with oral cetirizine hydrochloride (the active ingredient in QUZYTTIR) in patients 6 months to 17 years of age. Based upon the known PK profile of oral cetirizine hydrochloride, the exposure of IV cetirizine hydrochloride in pediatric patients (6 months to 17 years of age) is expected to be similar to the exposure of IV cetirizine hydrochloride in adults at the labeled doses. Extrapolation of efficacy is based on the likelihood that the disease course, pathophysiology and the drug's effect are similar between these two populations. 

The safety of QUZYTTIR in children 6 months to 17 years of age is supported by safety information from placebo-controlled clinical trials with oral cetirizine hydrochloride in patients 6 months of age and older [see Adverse Reactions (6)]. QUZYTTIR demonstrates a higher Cmax compared to oral cetirizine hydrochloride in adults [See Clinical Pharmacology (12.3)]. As QUZYTTIR is indicated for an acute condition administered in a medically supervised setting, the safety for higher Cmax in children 6 months to less than 18 years of age is supported by the safety data from the clinical trial with IV cetirizine hydrochloride in adults [see Adverse Reactions (6)] and available safety information from pediatric overdose cases. 

Because of the absence of pharmacokinetic and safety information for cetirizine hydrochloride in children below 6 years of age with impaired renal or hepatic function, the use of QUZYTTIR in this impaired patient population is not recommended [see Dosage And Administration (2)].

The safety and efficacy of QUZYTTIR in patients less than 6 months of age has not been established.
The neuronal etiology of obesity is centered around a diet-induced inflammatory state in the arcuate nucleus of the hypothalamus, which impairs the functionality of pro-opiomelanocortine neurons (POMCs) responsible for whole-body energy homeostasis and feeding behavior. Intriguingly, systemic salt inducible kinase 2 (SIK2) knockout mice demonstrated reduced food intake and energy expenditure along with modestly dysregulated metabolic parameters, suggesting a causal link between the absence of SIK2 activity in POMCs and the observed phenotype. To test this hypothesis, we conducted a comparative secretomics study from POMC neurons following pharmacologically induced endoplasmic reticulum (ER) stress induction, a hallmark of metabolic inflammation and POMC dysregulation in diet-induced obese (DIO) mice. Our data provide significant in vitro evidence for the POMC-specific SIK2 activity in controlling energy metabolism and feeding in DIO mice by regulating the nature of the related POMC secretome. Our data also suggest that under physiological stress conditions, SIK2 may act as a gatekeeper for the secreted inflammatory factors and signaling molecules critical for cellular survival and energy homeostasis. On the other hand, in the absence of SIK2, the gate opens, leading to a surge of inflammatory cytokines and apoptotic cues concomitant with the dysregulation of POMC neurons.
Absorption: Norethindrone is rapidly absorbed with maximum plasma concentrations occurring within 1 to 2 hours after DEBLITANETM administration (see Table 1). Norethindrone appears to be completely absorbed following oral administration; however, it is subject to first pass metabolism resulting in an absolute bioavailability of approximately 65%.

Peak plasma concentrations occur approximately 1 hour after administration (mean Tmax 1.2 hours). The mean (SD) Cmax was 4816.8 (1532.6) pg/mL and generally occurred within 1 hour (mean) of tablet administration, ranging from 0.5 to 2 hours. The mean (SD) C avg was 885 (250) pg/mL, however, the mean concentration at 24 hrs was 130 (47) pg/mL.

Table 1 provides summary statistics of the pharmacokinetic parameters associated with single dose Norethindrone Tablets administration.

The food effect on the rate and extent of norethindrone absorption after DEBLITANETM administration has not been evaluated.

Distribution: Following oral administration, norethindrone is 36% bound to sex hormone-binding globulin (SHBG) and 61% bound to albumin. Volume of distribution of norethindrone is approximately 4 L/kg.

Metabolism: Norethindrone undergoes extensive biotransformation, primarily via reduction, followed by sulfate and glucuronide conjugation; less than 5% of a norethindrone dose is excreted unchanged; greater than 50% and 20 to 40% of a dose is excreted in urine and feces, respectively. The majority of metabolites in the circulation are sulfate, with glucuronides accounting for most of the urinary metabolites.

Excretion: Plasma clearance rate for norethindrone has been estimated to be approximately 600 L/day. Norethindrone is excreted in both urine and feces, primarily as metabolites. The mean terminal elimination half-life of norethindrone following single dose administration of Norethindrone Tablet is approximately 8 hours.
Patients will receive p.o. the standard, most commonly used triple immunosuppression regimen: tacrolimus, mycophenolate mofetil, prednisone and p.o. famotidine 20 mg (group Famotidine).
The single patient treatment instructions for use are intended for a single patient with advanced soft tissue sarcoma. The patient will be treated with YONDELIS® (trabectedin) i.v. formulation at a dose of 1.5 mg/m2 i.v. over 24 hours on Day 1 every 21 days, provided that he/she fulfills all eligibility criteria.

The patient may continue to receive therapy until there is evidence of disease progression or unacceptable toxicity. Safety will be evaluated and serious adverse events will be reported. Disease assessments will occur according to institutional practice.
OBJECTIVE: This study aimed to evaluate the prevalence of sarcopenia and its clinical significance in Turkish women with SLE, exploring the association between muscle mass, muscle strength and SLE disease activity.
METHODS: A cross-sectional study was conducted at Gazi University Hospital's Department of Rheumatology from January to December 2020. It involved 82 patients with SLE, diagnosed according to the 2019 American College of Rheumatology/European Alliance of Associations for Rheumatology criteria, and 69 healthy controls. Sarcopenia was assessed using hand grip dynamometry (hand grip strength (HGS)) and bioelectrical impedance analysis for muscle mass, with sarcopenia defined according to the 2018 European Working Group on Sarcopenia in Older People criteria and specific cut-offs for the Turkish population. The main outcomes measured were the presence of sarcopenia and probable sarcopenia, HGS values, skeletal muscle mass index and SLE Disease Activity Index 2000 (SLEDAI-2K).
RESULTS: Among the patients with SLE, 51.2% met the criteria for probable sarcopenia and 12.9% were diagnosed with sarcopenia. The mean HGS was significantly lower in the SLE group (21.7±4.9 kg) compared with controls, indicating reduced muscle strength. The prevalence of anti-double-stranded DNA (anti-dsDNA) antibodies was 82.9%. Multivariate regression analysis identified height and levels of anti-dsDNA antibodies as independent predictors for developing probable sarcopenia. No significant association was found between clinical parameters, including SLEDAI-2K scores, and sarcopenia status.
CONCLUSIONS: Sarcopenia is prevalent among Turkish women with SLE, with a significant proportion showing reduced muscle strength. The study found no direct association between sarcopenia and SLE disease activity or clinical parameters. These findings underscore the importance of including muscle strength assessments in the routine clinical evaluation of patients with SLE to potentially improve management and quality of life.
Introduction and Aim: Life after stroke begins a difficult period in which functional capacity is very limited. Disability persists for a long time, and various problems such as hemiparesis, hemiplegia, dysarthria, dysphagia, urinary and bowel incontinence, which are frequently encountered after stroke, can affect the quality of life in the long term. As non-pharmacological approaches, especially non-invasive methods, have gained attention, creative arts-based therapies have often been recommended for stroke survivors because they have an arts-based approach without side effects. It is thought that the study conducted will contribute to the literature as there are not many studies in the literature. The aim of this study is to examine the effects of art-based activities on stroke patients' hope and self-efficacy levels. Its sub-purpose is to reveal the feelings and thoughts that arise with art objects obtained from art-based activities applied to stroke patients.

Materials and Methods: The study was conducted as a randomised controlled design. After the groups were determined, art-based activities module was applied to the intervention group for one week, while no additional intervention was made to the control group. This research was conducted at the Neurology Clinic of Health Sciences University Izmir Bozyaka Training and Research Hospital between October 2023 and February 2024. The participants consisted of 72 patient 36 in the invention group and 36 in the control group with Modified Rankin Scale scores of 2 and 3 who were hospitalized with a stroke diagnosis in the Neurology Clinic. Research data were collected using "Individual Introduction Form", "Herth Hope Index", "Generalized Self-Efficacy Scale. Data were analyzed with Statistical Package for the Social Sciences 25.0 package program. Written permission was obtained from the relevant ethics committee, hospital and participants to conduct the study.

This study was supported by Scientific and Technological Research Council of Turkey (TUBITAK) under the Grant Number 223K879.
The genes of Wnt/β-catenin pathway may have potential roles in fat accumulation of Non-traumatic osteonecrosis of the femoral head (ONFH), but the effects of their variants in the pathway on ONFH development have been remained unclear. To explore the potential roles of the variants in the development of ONFH, we completed the investigation of the paired interactions as well as their related biological functions of 17 variants of GSK3β, LRP5, and FRP4 genes etc. in the pathway. The genotyping of the 17 variants were finished by MASS ARRAY PLATFORM in a 560 ONFH case-control system. The association of variants interactions with ONFH risk and clinical traits was evaluated by logistic regression analysis etc. and bioinformatics technology. The results showed that the genotype, allele frequency, and genetic models of Gsk3β rs334558 (G/A), SFRP4 rs1052981 (A/G), and LRP5 rs312778 (T/C) were significantly associated with the increased and decreased ONFH risk and clinical traits, respectively (P < 0.001-0.0002). Particularly, the paired interactions of six variants as well as eight variants also showed statistically increased and decreased ONFH risk, bilateral hip lesions risk and stage IV risk of ONFH, respectively (P < 0.044-0.004). Our results not only at the first time simultaneously showed exact serum lipid disorder and abnormal platelet function of ONFH in the same study system with the 17 variants polymorphisms of Wnt/β-catenin pathway but also shed light on the variants closely intervening the lipid disorder and abnormal coagulation of ONFH.
OBJECTIVES: To explore the value of middle cerebral artery (MCA) plaque characteristics in predicting the outcomes of subacute ischemic stroke and the incremental value of the previous diet on predictive performance.
METHODS: One hundred and thirty-seven subacute ischemic stroke patients attributed to MCA plaques were included and analyzed in this prospective study. The National Institute of Health Stroke Scale (NIHSS) score, Mediterranean Diet Adherence Screener (MEDAS) score, and other clinical data were assessed. The plaque area, degree of stenosis, plaque burden, enhancement ratio, remodeling type, and intraplaque hemorrhage were measured using high-resolution MR vessel wall imaging (HR-VWI). Multivariable logistic regression analysis and receiver operating characteristic curve analysis were performed to assess the predictive performance of clinical and plaque characteristics for subacute ischemic stroke outcomes at 3 months.
RESULTS: Patients with poor outcomes exhibited high NIHSS scores, and low MEDAS scores (P<0.001). Plaque burden, enhancement ratio, and degree of stenosis were significantly higher in patients with poor outcomes (P<0.001). Multivariate analyses further indicated that NIHSS score (P=0.001), MEDAS score (P=0.013), and enhancement ratio (P=0.011) were independent predictors of subacute ischemic stroke outcomes. The three models' area under the curve (AUC) values were 0.811, 0.844, and 0.794. Combining these three factors resulted in an AUC of 0.908 (P<0.001).
CONCLUSIONS: The combination of NIHSS score, MEDAS score, and enhancement ratio showed significant superiority in the prognostic evaluation of subacute ischemic stroke. Clinical data combined with plaque characteristics improves the accuracy of 3-month outcome prediction on subacute ischemic stroke.
The invention discloses a traditional Chinese medicine preparation for treating aplastic anemia. The aplastic anemia can belong to the category of blood deficiency, blood depletion, consumptive disease and the like in the traditional Chinese medical science. Symptomatic treatment is adopted in the hospital, i.e. traditional Chinese medicines with effects of tonifying spleen and kidney, tonifying qi and nourishing blood are selected, such as Codonopsis pilosula, bighead atractylodes rhizome, Rhodiola rosea, Schisandra chinensis, Eucommia ulmoides, chaff flower root, wolfberry fruit, semen canavaliae, Semen sesami nigrum, sophora flower, rhizoma polygonati, semen cassiae and arillus longan, and the traditional Chinese medicines are prepared into a decoction for patients to take. Proved by clinical tests of the hospital, the total effective rate is 93.3 percent, and is obviously superior to that of a control group. Moreover, the traditional Chinese medicine preparation for treating the aplastic anemia does not have toxic and side effects after being taken for a long time, and is low in treatment cost.
Human and viral microRNAs (miRNAs) are involved in the regulation of gene transcription, and the establishment of their profiles in acute (AHI) and chronic (CHI) HIV infections may shed light on the pathogenetic events related to different phases of HIV disease. Next-generation sequencing (NGS) of miRNA libraries was performed, and the reads were used to analyze miRNA differential expression in the plasma with AHI and CHI. Functional analysis was then undertaken to investigate the biological processes characterizing the two phases of HIV infection. Except for hsa-miR-122-5p, which was found in 3.39% AHI vs. 0.18% CHI, the most represented human miRNAs were similarly represented in AHI and CHI. However, when considering the overall detected miRNAs in AHI and CHI, 15 displayed differential expression (FDR p < 0.05). Functional analysis identified 163 target mRNAs involved in promoting angiogenesis activation in AHI versus CHI through the action of hsa-miR10b-5p, hsa-miR1290, hsa-miR1-3p, and hsa-miR296-5p. The viral miRNAs detected, all belonging to herpesviruses, accounted for only 0.014% of total reads. The present data suggest that AHI patients exhibit strong innate immune activation through the upregulation of hsa-miR-122-5p and early activation of angiogenesis. More specific investigations are needed to study the role of viral miRNAs in HIV pathogenesis.
PURPOSE: A DNA-PK inhibitor for inducing differentiation of mesenchymal stem cells into vascular endothelial cells is provided to treat vascular diseases. CONSTITUTION: A method for inducing differentiation of mesenchymal stem cells into vascular endothelial cells comprises a step of treating the DNA-PK inhibitor to mesenchymal stem cells. The DNA-PK inhibitor is a compound of chemical formula 1. The compound of chemical formula 1 is 1-(2-hydroxy-4-mopolynophenyl)ethanon. The mesenchymal stem cells are prepared from bone marrow, tissue, embryo, umbilical cord blood, blood, or body fluid. A medicinal composition for treating vascular diseases contains differentiated vascular endothelial cells.
BLOXIVERZ is approved for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery in pediatric patients of all ages.

Recovery of neuromuscular activity occurs more rapidly with smaller doses of cholinesterase inhibitors in infants and children than in adults. However, infants and small children may be at greater risk of complications from incomplete reversal of neuromuscular blockade due to decreased respiratory reserve. The risks associated with incomplete reversal outweigh any risk from giving higher doses of BLOXIVERZ (up to 0.07 mg/kg or up to a total of 5 mg, whichever is less).

The dose of BLOXIVERZ required to reverse neuromuscular blockade in children varies between 0.03 mg - 0.07 mg/kg, the same dose range shown to be effective in adults, and should be selected using the same criteria as used for adult patients [see Clinical Pharmacology (12.3)]. 

Since the blood pressure in pediatric patients, particularly infants and neonates, is sensitive to changes in heart rate, the effects of an anticholinergic agent (e.g., atropine) should be observed prior to administration of neostigmine to lessen the probability of bradycardia and hypotension.
A drug delivery system of inorganic plate-type powder-mesoporous silica complex is provided to improve the release controlling property of functional cosmetic ingredient. A drug delivery system is formed by bonding hydrophilic head domain of mesoporous silica having drug on the surface of inorganic powder of plate type. The inorganic powder is talc, sericite, or mica. The drug is glycolic acid. The pore size of mesoporous silica is 2-50nm. A method for producing the drug delivery system comprises: a step of chelating inorganic plate type powder with bivalent metal; a step of coating an organic material on the chelated inorganic plate type powder; a step of dipping the drug in mesoporous silica; and a step of dipping the drug on coated inorganic plate type powder.
All participants receive direct clinic outreach plus enhanced outreach to communicate readiness of results (stage 1). Participants who do not attend the clinic by 30 days (non-responders) will receive asynchronous text message reminders using framed messaging (stage 2).
<P>PROBLEM TO BE SOLVED: To provide a catechin preparation useful for producing a beverage containing catechin at a high concentration having a good flavor.  <P>SOLUTION: A method for purifying the catechin preparation is characterized as follows. A solid catechin preparation containing 25-40 wt.% of nonpolymeric catechins is added to a solvent of an organic solvent and water in (10/0) to (8/2) weight ratio and water is then added thereto. Thereby, the weight ratio of the organic solvent to the water is regulated to (9/1) to (5/5). Insoluble solids are then removed to distill off the solvent.  <P>COPYRIGHT: (C)2004,JPO
It has been demonstrated that respiratory virus outbreaks and pandemics, such as influenza, SARS, MERS, and now the newly emerged SARS-COV2 virus, have a major impact on morbidity and mortality worldwide, as well as having devastating global economic and societal impact. During these outbreaks it is critical to gain a rapid understanding of the exposures and immunity in the general population. Current ongoing serosurvey efforts to estimate the prevalence of infection/exposure are focused on the general population, but these estimates may not be applicable to individuals living with rare diseases. An effort to identify the impact of this pandemic on this community is underway in the Rare Disease Clinical Research Network (RDCRN) led by the Data Management and Coordinating Center (DMCC) at Cincinnati Children s Hospital Medical Center (CCHMC) supported by NCATS. Through a survey they are attempting to evaluate infection rates and impact on those with rare diseases. In this study we propose to enroll a subset of the individuals participating in the RDCRN study to collect blood for SARS-Cov-2 antibody testing. This will allow us to add a biological marker to confirm infection/exposure and further our understanding of how widespread this infection is in the rare diseae community.
PSL Experts, prospectively identified and recruited by the PI after the general recruitment is completed. They will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
Pyridoxine Hydrochloride Injection may be administered intramuscularly or intravenously. In cases of dietary deficiency, the dosage is 10 to 20 mg daily for 3 weeks. Follow-up treatment is recommended daily for several weeks with an oral therapeutic multivitamin preparation containing 2 to 5 mg pyridoxine. Poor dietary habits should be corrected, and an adequate, well balanced diet should be prescribed.

The vitamin B6 dependency syndrome may require a therapeutic dosage of as much as 600 mg a day and a daily intake of 30 mg for life.

In deficiencies due to INH, the dosage is 100 mg daily for 3 weeks followed by a 30 mg maintenance dose daily.

In poisoning caused by ingestion of more than 10 g of INH, an equal amount of pyridoxine should be given — 4 g intravenously followed by 1 g intramuscularly every 30 minutes.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
During Weeks 0 to 16, participants randomized to the intervention arm will receive open-label sputum-guided management of airway inflammation (Table 1 in protocol) identified during screening (Figure 2 in protocol). Airway eosinophilia will be treated with regular inhaled corticosteroids based on the severity of eosinophilic inflammation. In participants with airway neutrophilia, as per the standard of care, sputum culture and sensitivity will be sent, and pathogenic organisms treated. Those participants with airway neutrophilia with negative cultures will be treated with thrice weekly Azithromycin (250mg). Combined eosinophilia and neutrophilia will receive treatment with both ICS and Azithromycin as per Table 2 in protocol.
Multiple Sclerosis (MS) is a chronic, inflammatory, demyelinating, autoimmune disease of the central nervous system. It is characterized by clinical symptoms arising from lesions in the brain, spinal cord or optic nerves. Although fatigue is one of the most common and most disabling problems of individuals with MS, it is not yet fully understood. This affects the treatment and disease process in MS. Despite studies to elucidate the pathogenic mechanisms of fatigue, available information is limited. Several factors contribute to the limited fatigue research, but the most important is that 'fatigue' is often not clearly defined or meaningful measures cannot be made in clinical/research settings. The first step in the evaluation of fatigue, which is a complex symptom, is to start with the identification and analysis of the factors that may cause fatigue, and to comprehensively question the factors that may be effective and the patient's history, and to evaluate the fatigue subjectively and objectively after the comprehensive patient history. The fatigue of patients diagnosed with MS will be evaluated subjectively, objectively and cognitively. Other information about the disease of the patients will be recorded. Subjective fatigue assessment methods, objective fatigue assessment methods and cognitive fatigue assessment methods will be applied.
Omega-3 Arm:1000 mg omega-3 fatty acids soft gel capsules (containing DHA 220 mg and EPA 330 mg) in two dose per day, to be taken orally with meal. Planned duration of the treatment is 12 weeks.