anthonyyazdaniml/gliner-biomed-curated-corpus huggingface dataset:
A total of 136 patients with EGPA were evaluated in 1 randomized, placebo-controlled, multicenter, 52-week treatment trial. Patients received 300 mg of NUCALA or placebo subcutaneously once every 4 weeks. Patients enrolled had a diagnosis of EGPA for at least 6 months prior to enrollment with a history of relapsing or refractory disease and were on a stable dosage of oral prednisolone or prednisone of greater than or equal to 7.5 mg/day (but not greater than 50 mg/day) for at least 4 weeks prior to enrollment [see Clinical Studies (14.3)]. Of the patients enrolled, 59% were female, 92% were White, and ages ranged from 20 to 71 years. No additional adverse reactions were identified to those reported in the severe asthma trials.

Systemic Reactions, including Hypersensitivity Reactions

In the 52-week trial, the percentage of patients who experienced systemic (allergic and non‑allergic) reactions was 6% in the group receiving 300 mg of NUCALA and 1% in the placebo group. Systemic allergic/hypersensitivity reactions were reported by 4% of patients in the group receiving 300 mg of NUCALA and 1% of patients in the placebo group. The manifestations of systemic allergic/hypersensitivity reactions reported in the group receiving 300 mg of NUCALA included rash, pruritus, flushing, fatigue, hypertension, warm sensation in trunk and neck, cold extremities, dyspnea, and stridor. Systemic non-allergic reactions were reported by 1 (1%) patient in the group receiving 300 mg of NUCALA and no patients in the placebo group. The reported manifestation of systemic non-allergic reactions reported in the group receiving 300 mg of NUCALA was angioedema. Half of the systemic reactions in patients receiving 300 mg of NUCALA (2/4) were experienced on the day of dosing.

Injection Site Reactions

Injection site reactions (e.g., pain, erythema, swelling) occurred at a rate of 15% in patients receiving 300 mg of NUCALA compared with 13% in patients receiving placebo.
PURPOSE:To obtain a mixture of 3 kinds of living bacteria useful as a main raw material for pharmaceuticals (e.g. intestine-conditioning agent), health foods, feeds, etc., by using lactic bacteria, saccharifying bacteria and butyric acid bacteria as active components. CONSTITUTION:The objective mixture can be produced by using lactic bacteria useful for human and animal (e.g. Streptococcus faecalis), saccharifying bacteria (e.g. Bacillus mesentericus) and butyric acid bacteria (e.g. Clostridium butyricum) as active components and mixing the components with an excipient such as potato starch, corn starch, lactose, sucrose, etc. The amounts of the saccharifying bacteria and butyric acid bacteria are preferably 4.5-5pts. and 5.0-5.5pts. per 1pt. of the lactic bacteria. The resistance of the mixture to heat, dryness and chemicals can be improved by using the saccharifying bacteria and butyric acid bacteria after sporulation.
A micron Taiwanofungus camphoratus liposome structure which includes a first and a second liposome shell is provided. The external radius of the first liposome shell is smaller than the internal radius of the second liposome shell, and the second liposome shell encloses the first liposome shell. A first space is defined inside of the first liposome shell, and a second space is defined between the inside surface of the second liposome shell and the outside surface of the first liposome shell. A plurality of cup-shaped structures is formed on the outside surface of the second liposome shell. Each cup-shaped structure is consisted of algae sugar and beta-cyclodextrin. The first space and the second space are for containing a first and a second active substance respectively. The Taiwanofungus camphoratus liposome structure contains active substances with different effects, such that the storage and transportation of multi-active substances is improved.
Nocturnal administration of dexmedetomidine (0.2-1.0 mcg/kg/h) during the first night after surgery. Dexmedetomidine infusion, not preceded by a bolus administration, will be started at 0.4 mcg/kg/h in the intervention group at 8 p.m. the day of surgery. Dexmedetomidine infusion will be titrated every 30 minutes with 0.1 mcg/kg/h steps until a RASS of -1 to -3 (drowsy, light to moderate sedation) is reached. The infusion will be discontinued at 6 a.m. the next morning.
Orthostatic Effects

A test for postural hypotension was conducted 2 to 6 hours after the first dose in the two 12-week, double-blind, placebo-controlled clinical studies. After the patient had been at rest in a supine position for 5 minutes, the patient was asked to stand. Blood pressure and heart rate were assessed at 1 minute and 3 minutes after standing. A positive result was defined as a > 30 mmHg decrease in systolic blood pressure, or a > 20 mmHg decrease in diastolic blood pressure, or a > 20 bpm increase in heart rate [see Warnings and Precautions (5.1)].

Cardiac Electrophysiology

The effect of RAPAFLO on QT interval was evaluated in a double-blind, randomized, active- (moxifloxacin) and placebo-controlled, parallel-group study in 189 healthy male subjects aged 18 to 45 years. Subjects received either RAPAFLO 8 mg, RAPAFLO 24 mg, or placebo once daily for five days, or a single dose of moxifloxacin 400 mg on Day 5 only. The 24 mg dose of RAPAFLO was selected to achieve blood levels of silodosin that may be seen in a “worst-case” scenario exposure (i.e., in the setting of concomitant renal disease or use of strong CYP3A4 inhibitors) [see Contraindications (4), Warnings and Precautions (5.3) and Clinical Pharmacology (12.3)]. QT interval was measured during a 24-hour period following dosing on Day 5 (at silodosin steady state).

RAPAFLO was not associated with an increase in individual corrected (QTcI) QT interval at any time during steady state measurement, while moxifloxacin, the active control, was associated with a maximum 9.59 msec increase in QTcI.

There has been no signal of Torsade de Pointes in the post-marketing experience with silodosin outside the United States.
INTRODUCTION: Critically ill patients with coronavirus disease 2019 (COVID-19) often face a heightened risk of morbidity and mortality, particularly due to complications such as acute kidney injury (AKI). While the persistent acute kidney injury risk index (PARI) has shown promise in predicting the risk of persistent AKI (pAKI) in non-COVID patients, its effectiveness in critically ill COVID-19 patients remains to be explored. We aimed to evaluate the predictive power of the PARI in identifying pAKI and its prognostic significance in terms of clinical outcomes.
METHODOLOGY: This was a single-center retrospective study of patients with COVID-19 admitted at our 36-bed tertiary intensive care unit between April and December 2020.
RESULTS: There were 152 patients who fulfilled our inclusion criteria. Fifty seven (37.5%) had developed AKI and 16 (10.25%) had developed pAKI. Vasopressor, mechanical ventilation and renal replacement therapy (RRT) requirement, sequential organ failure assessment (SOFA), and PARI were significantly higher in patients who developed pAKI than those who did not. The PARI were significantly higher in patients with short-term mortality compared to survivors. The area under the receiver operating characteristic (ROC) curve (AUC) of the PARI score for predicting pAKI was 0.66 (95% CI: 0.53-0.79), whereas short-term mortality was 0.733 (95% CI, 0.65-0.81).
CONCLUSIONS: The PARI score was evaluated as simple, useful, and reliable in predicting pAKI in severe cases with COVID-19; and therefore, pAKI and its related RRT complications can be prevented with protective interventions. Further comprehensive studies are warranted to deepen our understanding of this relationship.
The invention concerns MutS protein 13 and polynucleotide encoding it. The invention also concerns the process of producing the polypeptide by recombinant DNA technique. The methods for treating many diseases e.g. malignant tumor, hemopathy, infection of HIV, immunological diseases and a variety of inflammations utilizing the polypeptide are disclosed. The invention discloses the antagonist against the polypeptide and therapeutics thereof. The invention also discloses the uses of the polynucleotide, which encodes MutS protein 13.
This study examined the extent to which adolescent peer victimization predicted acute inflammatory responses to stress, and whether both resting parasympathetic nervous system (PNS) activity and PNS stress reactivity moderated this association. 83 adolescents (Mage = 14.89, SDage = 0.52, 48% female) reported their history of peer victimization and were exposed to a standardized social stress task before and after which dried blood spot samples were collected to assay inflammatory markers. Inflammatory responses to the stress task were assessed with a latent inflammatory change factor using the cytokines interleukin-6 (IL-6), interleukin-10 (IL-10), and tumor necrosis factor-α (TNF-α). PNS functioning, indexed by high-frequency heart rate variability, was measured at rest and during the stressor. Contrary to hypotheses, analyses revealed no direct relation between peer victimization and acute inflammatory responses, and resting PNS activity did not moderate this association. However, peer victimization predicted stronger inflammatory responses among adolescents with weaker PNS reactivity to the stress task (b = 0.63, p = .02). This association was not observed among adolescents with stronger PNS reactivity, for whom a negative but non-significant trend was found. Weaker PNS reactivity may thus indicate victimized adolescents' vulnerability for acute inflammatory responses, whereas stronger PNS reactivity may indicate adolescents' resilience to a social stressor.
Peritoneal fibrosis has been linked to hypoxia-inducible factor 1-alpha (HIF-1α) as well as O-linked-N-acetylglucosaminylation (O-GlcNAcylation) in peritoneal dialysis (PD). Genistein, recognized for its HIF-1α inhibitory and antifibrotic effects, presents a potential intervention against peritoneal mesothelial-mesenchymal transition (MMT) as well as fibrosis in PD. This study employed human peritoneal mesothelial cells (HPMCs) together with adenine-induced chronic kidney disease (CKD) rats undergoing peritoneal dialysis to explore Genistein's role in high glucose-induced peritoneal MMT and fibrosis. Our findings reveal that Genistein exerts anti-MMT and anti-fibrotic effects by inhibiting HIF-1α in HPMCs under high glucose conditions. Genistein inhibited O-GlcNAcylation status of HIF-1α through the mTOR/O-GlcNAc transferase (OGT) pathway, promoting its ubiquitination as well as the subsequent proteasomal degradation. In adenine-induced CKD rats undergoing peritoneal dialysis, Genistein suppressed the mTOR/OGT expression and reduced the abundance of O-GlcNAcylation along with HIF-1α in the peritoneum. Additionally, Genistein protected against increased peritoneal thickness, fibrosis, and angiogenesis, while improving peritoneal function. Based on our results, it could be inferred that Genistein might inhibit the abundance of HIF-1α via the mTOR/OGT pathway, thereby ameliorating MMT as well as fibrosis in PD.
We propose a longitudinal study of the natural history of types III and IV osteogenesis imperfecta for children age birth to 30 years. A consistent objective throughout this study is to obtain a comprehensive assessment of the natural history and progression of the multiple secondary features of osteogenesis imperfecta. In addition to radiographic, bone density, physical rehabilitation and dental manifestations, we will assess the cardiovascular, pulmonary, neurological, and audiology systems.

The major objectives of this protocol focus on rehabilitation and physical therapy studies, pulmonary and cardiovascular function, neurological features, audiological studies and genetic and molecular biology aspects of OI. A major objective in this study is to expand the intensive rehabilitation and physical therapy studies of children with types III and IV OI. This objective continues the work that has been done in the Rehabilitation Department of the Clinical Center for the past 20 years on these patients. However, the focus of this objective is changing to include studies of scoliosis and its effect on function, studies of chest proportions and rib deformities, and studies of nonkinetic variables related to motor performance, such as temperament, competence, coping, and resilience in children with OI. The second major objective is the longitudinal study of pulmonary function in children with types III and IV OI. It is well known that cardiopulmonary complications are a major cause of disability and death in adults with OI; the developmental patterns of these complications, and whether susceptible individuals can be identified in childhood, is unknown. The third major objective of these studies of secondary features is to determine the incidence of basilar invagination and develop a monitoring and management plan for this neurological feature. Next, the prevalence, severity, age of onset and genotypic/phenotypic correlation of hearing loss among children with types II and IV OI remains poorly understood; therefore, the study of audiological features is our fourth major objective. The final major objective in this study is the continued study of the genetic and molecular biology aspect of OI. Patients will have skin biopsies for collagen studies at the biochemical and molecular level. Parents will have blood drawn for determination of mosaic status for the mutation that causes their child s OI. These studies will provide further information on genotype/phenotype correlation and other variables in OI genetics. As appropriate, bone chips from emergency or elective surgical procedures on the participants will be used to study osteoblast function in OI.
Subjects in this single-arm study will have the targeted wound/ulcer treated with a combination therapy which includes the use of a wound preparation (2mL vial), a skin protectant (2mL vial), and a wound matrix (1.6g vial). Patients will be treated weekly for four weeks. Treatment may be continued weekly for an additional 8 weeks with participant and investigator agreement.
PURPOSE:To obtain a plaster having such a rigidity as to fix or support the affected part and proper touch to the skin by equipping a substrate comprising woven fabric or nonwoven fabric having bending resistance and tensile elastic stress of >= specific values with a plaster layer mixed with a medicinal component. CONSTITUTION:A substrate comprising woven fabric (e.g. cotton, nylon or rayon) or nonwoven fabric (e.g. rayon, polyester or cellulose) having >=40mm bending resistance by JIS L1,105 and >=0.7kg/25mm tensile elastic stress at 20% elongation is equipped with a plaster layer composed of a medicinal component (e.g. salicylic ester, crude drug, analgesic anti-inflammatory drug and anti- histamine agent) and a tacky agent in 100-350mum thickness to give a plaster. The plaster can provide a stable feeling by corset effects and shows treating effects such as subsidience of inflammation or pain killing because of possession of proper air permeability, water absorbing properties and warmness retaining effects.
The investigators will assess the efficacy of the RAPIDS intervention on preventing overdose among PWUD. Participants will be randomized 1:1 to receive the RAPIDS intervention or the attention-matched control condition. Experimental arm participants will receive the RAPIDS intervention, which includes education about the dangers of illicitly manufactured fentanyl (IMF), motivational interviewing to increase willingness to use fentanyl test strips and engage in overdose risk reduction behaviors, hands-on training to use the test strips, and opportunities to plan and role- play how to implement overdose risk reduction behaviors upon receipt of a positive or negative test result. In the attention-matched control arm, participants will receive standardized overdose education and naloxone distribution (OEND) training. All participants will attend additional study visits at months 1,2,3,6, and 12. The primary endpoint will be the rate of self-reported overdose over the follow-up period. Secondary endpoints (e.g., overdose death) will be ascertained by data linkage to statewide overdose surveillance databases.

The primary aims of this study are to: 1) Assess the efficacy of the RAPIDS intervention in reducing rates of overdose among people who use drugs; 2) Examine the degree to which reductions in rates of overdose are mediated by increases in information, motivation, behavioral skills, and self-efficacy regarding fentanyl, rapid fentanyl testing, and harm reduction practices; and 3) Explore whether there is heterogeneity of treatment effect related to key participant characteristics.
PURPOSE:To obtain the subject drug capable of improving the growth, etc., of domestic animals due to participation in keeping the balance of gut flora and capable of pelletizing by blending a hydrocarbon component derived from grains and tubers with spore-forming viable cells belonging to Bacillus genus. CONSTITUTION:An aqueous dispersion is prepared by using a hydrocarbon component derived from grains (corn powder, rice bran, etc.) and tubers in an amount of 0.01 pts.wt. (preferably 0.1-10 pts.wt.) based on 1 pts.wt. spore- forming cells belonging to Bacillus genus (preferably Bacillus toyoi) containing <=about 10<13>-10<15> viable cell per 1kg cell weight) and subsequently subjected to spray drying, etc., to obtain the objective drug. By mixing the above- mentioned drug into a feed, etc., for animals and pelletizing the resultant mixture by a pelletizer, the subject pellet-shaped feed can be obtained.
A surgical computing system may provide first information about a surgical procedure to a recommendation model. The first information may include the identity of an observation point of a surgical device to be used during the surgical procedure. The surgical device may collect data descriptive of an object of the observation point. The surgical computing system may receive second information from the recommendation model. The second information may be indicative of a recommended schema for the observation point. The recommended schema may define a timing via which the surgical device is to collect data. The surgical computing device may send, to the surgical device, an instruction to collect, during the surgical procedure, data descriptive of an object of the observation point according to the timing defined by the recommended schema.
The invention discloses an extraction method of a rhizoma cyperi extract, which comprises the following process steps: soaking rhizoma Cyperi in water as starting solvent, decocting, filtering to remove residue, and collecting filtrate. The liquid was concentrated under reduced pressure. Adsorbing the concentrated liquid by macroporous adsorption resin column, and eluting with ethanol to obtain eluate. Adding diatomite into the eluent, heating, refluxing and decoloring, and collecting filtrate. The filtrate was passed through an exchange resin to remove impurities. And finally, recovering the ethanol in the filtrate, and drying the residual substances to obtain the finished product. Compared with the prior art, the method has the advantages of low cost, low impurity content, no environmental pollution in the production process and the like.
The present invention generally relates to transdermal delivery and, in particular, to transdermal delivery using nanoemulsions and other emulsions. In one aspect, the present invention is directed to emulsions comprising a first, continuous phase and a second, discontinuous phase. The first phase may be an aqueous liquid and the second phase may comprise a lipid, such as isopropyl myristate. In some cases, a surfactant, such as Pluronic® L61, is used to stabilize the emulsion. Surprisingly, it has been found that such emulsions are effective at delivering pharmaceutically active agents, such as ciprofloxacin, when the formulation has a very low water content, for example, less than 30 wt% or less than 10 wt%. This is surprising because high water contents — not low water contents — are typically correlated with greater transdermal drug delivery, and thus, a low water content would have been considered to be unfavorable for facilitating transdermal drug delivery.
AASV, including Wegener's granulomatosis (WG) and microscopic polyangiitis (MPA) and renal limited vasculitis (RLV), are progressive, multisystem, autoimmune diseases which require the prescription of immunosuppressive therapy. Treatment using corticosteroids and cytotoxic drugs has been standardised (ECSYSVASTRIAL project), but relapse rate remains high and treatment-related toxicity is non negligible. The IMPROVE trial aims to reduce this relapse rate by using mycophenolate mofetil (MMF) for maintenance therapy. The potential benefit of MMF has been suggested in a published open and uncontrolled study. Patients with newly diagnosed systemic AASV will be randomly assigned to receive either MMF or reference treatment with azathioprine (AZA), once remission has been obtained with cyclophosphamide and prednisone. MMF and AZA will be continued for a total of 42 months of therapy with concomitant prednisone dose tapering. The study will last 48 months. Hence, within the last 6 months of the study duration, the patients will not receive any immunosuppressive drugs.

The primary end-point will the disease-free period, taken as the period of time from remission until relapse or study end; secondary end-points will be adverse events, cumulative damage (assessed using damage score VDI) and immunosuppressive drug cumulative dose.
The use of ZOLADEX in patients at particular risk of developing ureteral obstruction or spinal cord compression should be considered carefully and the patients monitored closely during the first month of therapy. Patients with ureteral obstruction or spinal cord compression should have appropriate treatment prior to initiation of ZOLADEX therapy [see Warnings and Precautions (5.2) and Adverse Reactions (6.2)].

The use of GnRH agonists may cause a reduction in bone mineral density. In men, data suggest the use of a bisphosphonate in combination with a GnRH agonist may reduce bone mineral loss [see Adverse Reactions (6.8) and (6.10)].

Patients should be informed that diabetes or loss of glycemic control in patients with pre-existing diabetes has been reported during treatment with GnRH agonists, including ZOLADEX. Therefore, consideration should be given to monitoring blood glucose and/or glycosylated hemoglobin (HbA1c) periodically in patients receiving ZOLADEX [see Warnings and Precautions (5.3)].

A small increased risk of developing myocardial infarction, sudden cardiac death and stroke has been reported in association with use of GnRH agonists in men. Patients receiving a GnRH agonist should be monitored for symptoms and signs suggestive of development of cardiovascular disease and be managed according to current clinical practice [see Warnings and Precautions (5.4)].

Injection site injury has been reported following injection of ZOLADEX. Inform patients to contact their doctor immediately if they experience any of the following symptoms: abdominal pain, abdominal distension, dyspnea, dizziness, hypotension and/or any altered levels of consciousness [see Warnings and Precautions (5.9)].