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

There are no available data on the use of SOGROYA during pregnancy; however, published studies describing the use of short-acting recombinant growth hormone (rhGH) during pregnancy over several decades have not identified any drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, subcutaneously administered somapacitan-beco was not teratogenic in rats or rabbits during organogenesis at doses approximately 12 times the clinical exposure at the maximum recommended human dose (MRHD) of 8 mg/week. No adverse developmental outcomes were observed in a pre- and post-natal development study with administration of somapacitan-beco to pregnant rats from organogenesis through lactation at approximately 275 times the clinical exposure at the MRHD (see Data).

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

Data

Animal Data

In an embryo-fetal development study in rats, somapacitan-beco was administered by subcutaneous injection at doses of 2, 6, and 18 mg/kg/day during the period of organogenesis from gestation day 6 to 17. Fetal viability and development were not affected at doses up to 6 mg/kg/day (31 times the MRHD, based on AUC). Transient, fetal skeletal variations (short/bent/thickened long bones) were observed at 18 mg/kg/day (261 times the MRHD, based on AUC). 

In an embryo-fetal development study in rabbits, somapacitan-beco was administered by subcutaneous injection at doses of 1, 3, and 9 mg/kg every two days during the period of organogenesis from gestation day 6 to 18. Fetal viability and development were not adversely affected at somapacitan-beco dose of 1 mg/kg/every two days (12 times the MRHD, based on AUC). Reduced fetal growth was observed at doses ≥3 mg/kg/every two days (≥130 times the MRHD, based on C12h).

In a pre- and post-natal development study in pregnant rats, somapacitan-beco was administered by subcutaneous injection at doses of 4, 9, and 18 mg/kg twice a week from gestation day 6 through lactation day 18. No adverse developmental effects were observed in the offspring at doses up to 9 mg/kg (275 times the MRHD, based on AUC). Increased incidence of renal pelvic dilatation was observed on post-natal day 21 at 18 mg/kg (630 times the MRHD, based on AUC), but was not observed in the adult F1 generation.
Centralized systems execute one or more applications for monitoring and operating a plurality of network enabled medical devices. An indication to start a selected application at the centralized system or at a network enabled medical device is received at the centralized system/network enabled medical device. The selected application may require a license to operate and, at the time the indication is received, may have a first license available. Instead of using the first license, the centralized system/network enabled medical device may determine to inherit at least a portion of a second license to operate the selected application. The centralized system/network enabled medical device may inherit at least the portion of the second license to form an inherited license, where the inherited license enables features of the selected application. Using the inherited license, the selected application is started with the enabled features. Related apparatus, systems, techniques and articles are also described.
Dust mites belonging to the genus Dermatophagoides are indoor allergens found in humid geographic locations worldwide. D. farinae and D. pteronyssinus occur widely with most homes in the United States coinhabited by both species. 11

12.1 Mechanism of Action

The complete mechanisms of allergen immunotherapy are not clear and remain the subject of investigation. The allergic reaction is dependent on the presence of allergen-specific immunoglobulin E (IgE) antibodies that are bound to specific receptors on mast cells and basophils. The presence of IgE antibodies sensitizes these cells, and upon interaction with the appropriate allergens, histamine and other mediators are released which produce local or systemic responses in sensitive individuals, and characteristic symptoms of atopic diseases, such as allergic rhinitis and allergic asthma. Changes in serum antibody and T-lymphocyte responses resulting from immunotherapy have been demonstrated, and these changes often correlate closely with clinical (symptom) improvements. Specific mechanisms may vary depending on the nature of the allergic disease, the allergenic specificities of patients and populations, extract formulations, route of administration, dose and duration of treatment. 2

Subcutaneous administration of allergenic extracts is known to elicit numerous immunological changes that are both time and dose-dependent. Many of these changes appear to be related to (or a precursor to) improvements in symptoms and other clinical parameters, as noted above. Specific changes found after immunotherapy with dust mite extracts include significant increases in mite-specific IgG4 antibodies 12, interleukin-10-positive T cells, and several T-cell receptors, and significant decreases in serum nitric oxide, eosinophil catonic protein, interleukin-4-positive T cells and IgE-mediated basophil histamine release. 13
BACKGROUND: Severely infected diabetic ulcers of the big toe often necessitate surgical treatment. Depending on the wound stage and presence of osteomyelitis, conservative surgery and amputation are the main surgical treatments. Few articles reported the outcomes and complications of such procedures. This study is a preliminary comparative report on the early outcomes and complications of hallucal diabetic foot infection (DFI) treated with either conservative surgery or amputation.
METHODS: This is a retrospective comparative study comprising a continuous series of patients admitted at our hospital. Initially, all diabetic foot ulcer (DFU) were infected and at advanced stage (Wagner Grade 3 or 4). All clinically suspected cases of osteomyelitis were confirmed by bone pathology and microbiology culture. The study included 37 patients diagnosed with DFI. Infection profile was as follows: 23 DFU with osteomyelitis (Wagner Grade 3 or 4) and 14 infected DFU (Wagner Grade 2). Twenty-four conservative procedures and 13 amputation surgeries were performed initially. The primary outcome was defined as the frequency of subsequent surgery (deep infection recurrence treated with surgery). Statistical analysis was used to look for significant difference between both groups.
RESULTS: Ten patients (27%) required additional surgeries because of deep infection recurrence. Four recurrences (16.7%) were observed in the conservative group and 6 (46%) in the amputation group (P = 0.054). Amputation rate as a subsequent procedure was 8.3% for the conservative group and the reamputation rate for the amputation group was 23.1% (P = 0.2).
CONCLUSIONS: The study findings would indicate that the more severe is the initial hallucal infection severity (higher Wagner grade), the higher is the frequency of early surgical complications mainly after an index amputation procedure. Our assessment tools of initial infection extent seem to be underperforming. A more aggressive treatment in the form of a more proximal cut with regard to magnetic resonance imaging bone infection signal could be considered to minimize the risk of subsequent surgeries and reamputations.
A portable meditation-based "Mantram Repetition Program (MRP)" will be delivered individually in 8-weekly 1 hour sessions to teach a set of strategies for training attention to manage symptoms. For this study, the program targets symptoms of posttraumatic stress disorder (PTSD) in Veterans who have experienced military-related trauma.
Patients with tissue inflammation or injury often experience aberrant mechanical pain hypersensitivity, one of leading symptoms in clinic. Despite this, the molecular mechanisms underlying mechanical distortion are poorly understood. Canonical transient receptor potential (TRPC) channels confer sensitivity to mechanical stimulation. TRPC3 and TRPC6 proteins, coassembling as heterotetrameric channels, are highly expressed in sensory neurons. However, how these channels mediate mechanical pain hypersensitivity has remained elusive. It is shown that in mice and human, TRPC3 and TRPC6 are upregulated in DRG and spinal dorsal horn under pathological states. Double knockout of TRPC3/6 blunts mechanical pain hypersensitivity, largely by decreasing nociceptor hyperexcitability and spinal synaptic potentiation via presynaptic mechanism. In corroboration with this, nociceptor-specific ablation of TRPC3/6 produces comparable pain relief. Mechanistic analysis reveals that upon peripheral inflammation, TRPC3/6 in primary sensory neurons get recruited via released bradykinin acting on B1/B2 receptors, facilitating BDNF secretion from spinal nociceptor terminals, which in turn potentiates synaptic transmission through TRPC3/6 and eventually results in mechanical pain hypersensitivity. Antagonizing TRPC3/6 in DRG relieves mechanical pain hypersensitivity in mice and nociceptor hyperexcitability in human. Thus, TRPC3/6 in nociceptors is crucially involved in pain plasticity and constitutes a promising therapeutic target against mechanical pain hypersensitivity with minor side effects.
The patellofemoral pain syndrome also known as anterior knee pain is a common entity in young athletic population. In patellofemoral knee syndrome, one of the theory is that the vastus medialis obliquus muscle is weak. To strengthen the muscle, physical therapy exercises are commonly used. This study evaluates addition of the electrical muscle stimulation device.The electrical muscle stimulation device "Flex MT Plus" (Electrostim Medical Services Inc. Tampa, FL) is a FDA approved device and has been used in knee for other conditions like treating for weakness associated with knee injuries or after knee surgeries. It has shown to improve the outcomes in above mentioned conditions. Its efficacy has been tested in patellofemoral pain syndrome but in smaller sample size. We intend to test it in larger sample size patient population.

Bily et al (2008) (reference #1) published their results on patellofemoral pain syndrome comparing EMS +PT to PT only and found that overall significant improvement in outcome score in all patients but when compared between the groups there was no difference. But there sample size was 19 patients in each group. Small sample size was one of the limitation of their study. We intend to collect 46 patients in each group to find significant difference based on power analysis.
Brown adipose tissue (BAT) is the main site of nonshivering thermogenesis which plays an important role in thermogenesis and energy metabolism. However, the regulatory factors that inhibit BAT activity remain largely unknown. Here, cardiotrophin-like cytokine factor 1 (CLCF1) is identified as a negative regulator of thermogenesis in BAT. Adenovirus-mediated overexpression of CLCF1 in BAT greatly impairs the thermogenic capacity of BAT and reduces the metabolic rate. Consistently, BAT-specific ablation of CLCF1 enhances the BAT function and energy expenditure under both thermoneutral and cold conditions. Mechanistically, adenylate cyclase 3 (ADCY3) is identified as a downstream target of CLCF1 to mediate its role in regulating thermogenesis. Furthermore, CLCF1 is identified to negatively regulate the PERK-ATF4 signaling axis to modulate the transcriptional activity of ADCY3, which activates the PKA substrate phosphorylation. Moreover, CLCF1 deletion in BAT protects the mice against diet-induced obesity by promoting BAT activation and further attenuating impaired glucose and lipid metabolism. Therefore, our results reveal the essential role of CLCF1 in regulating BAT thermogenesis and suggest that inhibiting CLCF1 signaling might be a potential therapeutic strategy for improving obesity-related metabolic disorders.
The present invention relates to microbial technology field, Artemisia japonica endogenetic fungus of the present invention from the Japanese wormwood herb botanical live body that suburb, Guiyang City, Guizhou Province gathers, adopts endogenetic fungus isolation technics to be separated obtain, identify through microbial taxonomy, can the outstanding Wei of called after intend dish stey (Pestalotiopsis? uvicola) GMH31, this bacterial strain is in China typical culture collection center preservation, preservation date on June 30th, 2014, preservation registration number CCTCC? NO:M2014303.Does is the most significant feature of the present invention that this bacterial strain fermentation liquor can produce fungal diseases of plants pathogen as kiwi fruit brown rot germ (Sclerotinia? and phytophthora blight of pepper (Phytophthora sclerotiorum)? etc. capsici) having inhibiting active metabolite, is agriculturally important microbial resources.
The thymus is the major organ of T cell production and is generally believed to be nonfunctional in adults. Even if nonfunctional, it is destroyed by HIV infection while T cells are destroyed in the peripheral lymphoid system. Given the absence of new T cell production and a pathologic acceleration of T cell destruction, the immune system collapses and immunodeficiency ensues.

However, some studies have demonstrated thymic function in adults with HIV disease. Such function may be induced by positive feedback regulation of T cell production and the presence or absence of such function may play a determinant role in disease progression and response to highly active antiretroviral therapy (HAART). These studies suggest that the thymus is functional in many adults with HIV disease and that thymic function might be induced as a consequence of HIV-mediated peripheral T cell depletion. Growth hormone is a potent regulator of thymic function. This study will determine whether true thymic function can be induced in HIV infected adults, whether such induction is indeed prompted by growth hormone, and whether thymic function plays a role in sustaining the T cell compartment in the face of peripheral T cell depletion.

Twenty-four volunteers will be enrolled in this 2 year study. All participants will receive 12 months of treatment with human growth hormone. Participants will be randomly assigned to one of two study arms. Twelve participants (Arm 1) will receive growth hormone during the first year of the study (3 mg given daily by subcutaneous injection, with dose reduction to 1.5 mg after 6 months). Twelve participants (Arm 2) will be enrolled in an observational control arm (no placebo injections) that will cross over to growth hormone treatment after 1 year. Participants, whether in Arm 1 or Arm 2, will have as many as 24 scheduled study visits during the 2 years after enrollment. In general, study visits occur every every 1 to 3 months. Study visits will include physical exams, blood tests, CT scans, PET scans, and DEXA scans.
The invention provides an oxiracetam agent and the preparation method, which relates to medical technical field and is used to induce the drug to penetrate through blood-brain barrier and to improve treatment effects. The agent contains oxiracetam nano-particle and excipientpharmaceutical excipient. After improved, the oxiracetam nano-particle and excipientpharmaceutical excipient contains drug core and a modified layer. The drug core mainly comprises principal agent and carrier, wherein the carrier is polymer material containing amino polysaccharide with a content of 70 to 95 percent, and the principal agent is oxiracetam with a content of 5 to 30 percent. The invention adopts polymer material containing amino polysaccharide as carrier to carry the oxiracetam and endow the oxiracetam with good brain targeting function. And the invention adopts surfactant to modify the nano surface of the carrier and lengthens the recycling time of the carrier nano-granule and the nano-particle in the recycling system. Tests show that the blood-brain barrier transmittance is 24h, which is 36.75 percent higher than ordinary oxiracetam agent and greatly enhances the dosage of oxiracetam passing through the blood-brain barrier.
Human papillomavirus (HPV) vaccines received regulatory approval and were recommended for use in young girls nearly 2 decades ago. Uptake is mostly high in resource-rich settings. In resource-limited settings, where the burden of cervical cancer is disproportionately high, access to and uptake of HPV vaccines are nowhere near satisfactory, despite evidence that HPV vaccination is highly cost-effective and a significant value-for-money investment. The discovery that only a single dose of the HPV vaccines may be needed to confer adequate protection may make equitable access to HPV vaccines possible. Indeed, the recent World Health Organization recommendation allowing for 1 or 2 doses is already gaining traction. This monograph aims to update the state of the science related to single-dose HPV vaccine protection and includes both primary data and modeling efforts that address key gaps in the knowledge regarding 1) durability of protection of a single dose of the HPV vaccine, 2) single-dose HPV vaccine effectiveness in both high-income and low-income settings, 3) implementation of single-dose HPV vaccination, and 4) how to accelerate control of cervical cancer by integrating a 1-time screen for cervical disease. The content published in this monograph will continue to advance the science of HPV vaccination and will be vital as new countries make informed decisions about how best to use this remarkable vaccine.
An oral, pharmaceutical suspension composition of Fexofenadine. Fexofenadine is a mixture of compacted Fexofenadine and plain fexofenadine in a ratio of 0.01: 0.99 to 0.99 to 0.01 having a mean particle size of fexofenadine particles in the range of 10??and 250??. An oral, pharmaceutical suspension composition of Fexofenadine, which is bioequivalent to a tablet dosage form of fexofenadine marketed under the trade name of Allegra??. Bioequivalence between a suspension formulation and the commercially tablet formulation of fexofenadine i.e. 'Allegra??, is achieved by the use of a mixture of compacted Fexofenadine.
FIELD: medicine. SUBSTANCE: invention relates to composite materials, mainly, to supporting functions in stomatological and orthopedic applications. Invention relates to method for preparing biologically active composite material involving apatite being material comprises groups with tendency to decomposition. Material thickening is carried out at high temperatures under pressure in the closed system where before the final thickening temperature and to onset of decomposition of apatite phase pressure above 100 MPa is applied at temperature below 900 C for ceramics-base composite and at temperature 600 C or below for metalbase composites and also material comprising apatite that includes groups with tendency to decomposition. EFFECT: improved preparing method, valuable properties of material. 12 cl, 1 dwg, 5 ex
OBJECTIVES: To identify the effectiveness of an android-based paediatric assessment triangle application in emergency diagnostics.
METHODS: The action research study was conducted in the emergency department of a hospital under the Ministry of Defence, Indonesia, located within the Ministry of Defence Rehabilitation Centre Complex, from April to December 2020 after approval from the ethics review committee of the Faculty of Nursing, Universitas Indonesia, Indonesia, employing quantitative and qualitative methods consisting of planning, acting, observing and reflecting stages. Emergency department nurses with at least D3 nursing graduation who were able to identify emergency status in children were included. The subjects were given training on paediatric assessment triangle application before using it in their professional life. The difference was noted through pre- and post-intervention tests. Qualitative data was collected using focus group discussion and system usability scale.
RESULTS: Of the 9 nurses, 5(55.6%) were males, 4(44.4%) were females, 8(88.9%) were aged 26-35 years, and 2(22.2%) had professional experience 1-2 years. The mean baseline score was 36.1±11.4, while the mean post-intervention score was 70.9±14.4. The fastest application completion time was 13 seconds, while the slowest was 52 seconds. Qualitative data led to the emergence of 4 themes: time required to complete the application; preference for connectivity with the hospital's electronic record system; assessment of children's clinical status; and, unfamiliarity with the computerised system. The mean system usability scale score was 72.22±11.35 (range: 52.5-92.5).
CONCLUSIONS: Paediatric assessment triangle application could be a valid tool for identifying emergency severity in patients during the triage process.
The safety and effectiveness of CIBINQO in pediatric patients 12 years of age and older with atopic dermatitis have been established. 

In trials Trial-AD-1 and Trial-AD-2, 124 pediatric subjects 12 to less than 18 years old weighing 25 kg or more with moderate-to-severe atopic dermatitis were enrolled and randomized to receive either CIBINQO 100 mg (N=51), 200 mg (N=48), or matching placebo (N=25) in monotherapy. Additional 284 pediatric subjects 12 to less than 18 years of age weighing 25 kg or more with moderate-to-severe atopic dermatitis, were enrolled and randomized to receive either CIBINQO 100 mg (N=95) or 200 mg (N=94) or matching placebo (N=95) in combination with topical corticosteroids in Trial-AD-4. Efficacy and adverse reaction profile were comparable between the pediatric patients and adults [see Clinical Studies (14) and Adverse Reactions (6.1)].

The safety and effectiveness of CIBINQO have not been established in pediatric patients below 12 years of age.

Juvenile Animal Toxicity Data

In a juvenile animal toxicity study, abrocitinib was administered orally to juvenile rats at doses of 5, 25, and 75 mg/kg/day from postnatal day 10 (approximately equivalent to a human infant) through postnatal day 63 (approximately equivalent to an adolescent). Abrocitinib caused a reversible, dose‑related decrease in the primary spongiosa in the metaphysis of the proximal tibia and distal femur and adverse effects on bone development at all dose levels. Abrocitinib caused irreversible dose-related small or misshapen femoral heads at doses ≥5 mg/kg/day (0.8 times the MRHD based on AUC comparison); irreversibly decreased femur size and caused paw malrotation and limb impairment at doses ≥25 mg/kg/day (7.2 times the MRHD based on AUC comparison); and fractures at 75 mg/kg/day (27 times the MRHD based on AUC comparison).

In a follow-up study, abrocitinib (25 mg/kg/day, at least 4.5 times the MRHD based on AUC comparison) was orally administered to juvenile rats from postnatal day (PND) 10, 15, 21, or 30 through PND day 63. Administration beginning PND 10 caused adverse macroscopic and microscopic bone findings consistent with the previous juvenile animal study. However, administration beginning PND 15 (approximately equivalent to a 6- to 12-month old infant) caused non-adverse reversible microscopic bone findings. No bone findings were noted when administration began on PND 21 or 30 (approximately equivalent to 2- and 6-year old children, respectively).