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

If HARVONI is administered with ribavirin, the combination regimen is contraindicated in pregnant women and in men whose female partners are pregnant. Refer to the ribavirin prescribing information for more information on ribavirin-associated risks of use during pregnancy.

No adequate human data are available to establish whether or not HARVONI poses a risk to pregnancy outcomes. In animal reproduction studies, no evidence of adverse developmental outcomes was observed with the components of HARVONI (ledipasvir or sofosbuvir) at exposures greater than those in humans at the recommended human dose (RHD) [see Data]. During organogenesis in the rat and rabbit, systemic exposures (AUC) to ledipasvir were approximately 4 (rats) and 2 (rabbits) times the exposure in humans at the RHD, while exposures to the predominant circulating metabolite of sofosbuvir (GS-331007) were ≥3 (rats) and 7 (rabbits) times the exposure in humans at the RHD. In rat pre/postnatal development studies, maternal systemic exposures (AUC) to ledipasvir and GS-331007 were approximately 5 and 7 times, respectively, the exposure in humans at the RHD.

The background risk of major 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 2–4% and 15–20%, respectively.

Data

Animal Data

Ledipasvir: Ledipasvir was administered orally to pregnant rats (up to 100 mg/kg/day) and rabbits (up to 180 mg/kg/day) on gestation days 6 to 18 and 7 to 20, respectively, and also to rats (oral doses up to 100 mg/kg/day) on gestation day 6 to lactation/post-partum day 20. No significant effects on embryo-fetal (rats and rabbits) or pre/postnatal (rats) development were observed at the highest doses tested. Systemic exposures (AUC) to ledipasvir were ≥4 (rats) and 2 (rabbits) times the exposure in humans at the RHD.

Sofosbuvir: Sofosbuvir was administered orally to pregnant rats (up to 500 mg/kg/day) and rabbits (up to 300 mg/kg/day) on gestation days 6 to 18 and 6 to 19, respectively, and also to rats (oral doses up to 500 mg/kg/day) on gestation day 6 to lactation/post-partum day 20. No significant effects on embryo-fetal (rats and rabbits) or pre/postnatal (rats) development were observed at the highest doses tested. Systemic exposures (AUC) to the predominant circulating metabolite of sofosbuvir (GS-331007) were ≥3 (rats) and 7 (rabbits) times the exposure in humans at the RHD, with exposures increasing during gestation from approximately 3 to 6 (rats) and 7 to 17 (rabbits) times the exposure in humans at the RHD.
BACKGROUND: The Omicron variant of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is known to be more infectious and less severe than the other variants. Despite the increasing number of symptomatic patients, severe neurological complications in children with the Omicron variant have been reported rarely, unlike with wild-type or Delta variants. This study aimed to investigate severe neurological complications in children with Omicron variant infection.
METHODS: We conducted a retrospective study of 17 pediatric patients with severe neurological manifestations associated with coronavirus disease 2019 in Korea during the Omicron variant prevalence, from January 1 to April 30, 2022.
RESULTS: Among the 17 patients, 11 had pre-existing neurological disabilities and nine met the criteria for multisystem inflammatory syndrome in children (MIS-C). Four of the five vaccine-eligible patients (12 years and older) were unvaccinated. Severe neurological manifestations included acute necrotizing encephalopathy, acute fulminant cerebral edema, acute disseminated encephalomyelitis, basal ganglia encephalitis, unclassified severe encephalopathy/encephalitis, and refractory status dystonicus. Patients with MIS-C and underlying neurological disabilities had longer median hospital and intensive care unit stays compared with those without these conditions. Five patients survived with new neurological deficits at the one-year follow-up, and three died, all of whom had underlying neurological disabilities.
CONCLUSIONS: This study shows that severe neurological complications in pediatric patients with the Omicron variant of SARS-CoV-2 occur infrequently but may lead to significant morbidity and mortality, especially among those with pre-existing neurological disabilities and unvaccinated individuals. Continued efforts are necessary to prevent and manage such complications in these vulnerable populations.
Zzowin Nutra Tablet contains Melatonin, Tagar, L-theanine, L-Tryptophan, vitamin B6, Iron, Zinc, and Magnesium. which is helpful to provide deep, calm, and restful sleep.
Patients will be transferred from MDI to sensor-augmented pump (SAP) in group using specialised structured education program. CGM will be used for self monitoring of blood glucose permanently within 4 month.
BACKGROUND: Hepatitis B virus (HBV) clearance depends on an effective adaptive immune response, especially HBV-specific T cell-mediated cellular immunity; however, it is difficult to produce enough HBV-specific T cells effectively.
RESULTS: In this work, we investigated the proportions of stimulated cells, serum, and culture media as the three primary factors to determine the most effective procedure and applied it to HLA-A2 (+) people. In parallel, we also examined the correlation between clinical parameters and HBV-specific immunity. Concerning amplification efficiency, 4 × 105 cells stimulation was superior to 2 × 106 cells stimulation, AIM-V medium outperformed 1640 medium, and fetal bovine serum (FBS) exceeded human AB serum under comparable conditions. As expected, this procedure is also suitable for developing HBV-specific CD8 + T cells in HLA-A2(+) individuals. Expanded HBV-specific T cell responses decreased with treatment time and were negatively correlated with HBV DNA and HBsAg. Furthermore, the number of HBV-specific IFN-γ + SFCs was strongly correlated with the ALT level and negatively correlated with the absolute lymphocyte count and the ALB concentration.
CONCLUSIONS: We confirm that stimulating 4 × 105 PBMCs in AIM-V medium supplemented with 10% FBS is the best approach and that HBeAg, HBsAg, and ALB are independent predictors of HBV-specific T-cell responses.
Patients who are randomized in Multiples-set (MS) group, will receive 12-week of combined training, twice a week, composed by 10 resistance exercises and 20-25 minutes aerobic exercise at 80-95% of the second ventilatory threshold heart rate in a cycle. Regarding resistance exercises, three set will be performed per exercise at 60-80%1-RM, with 1-1,5min of rest between sets and the exercises.
The tablet, which is coloured in water and changes to colourless when cleaning is complete, contains a chelating agent, as oxygen-contg. agent, a perborate and/or polymeric phosphate(s) and as dye a redox indicator esp. a water-sol. keto-enol blue-white indigo dye such as the Na salt of an indigotindisulphonic acid. The chelating agent is a citrate and/or tartrate and/or phosphate and/or polyphosphate. Action is rapid - 10-15 mins and independent of the water used.
When Reversal of Naltrexone Hydrochloride Blockade is Required for Pain Management: In an emergency situation in patients receiving fully blocking doses of naltrexone hydrochloride, a suggested plan of management is regional analgesia, conscious sedation with a benzodiazepine, use of non-opioid analgesics or general anesthesia. 

In a situation requiring opioid analgesia, the amount of opioid required may be greater than usual, and the resulting respiratory depression may be deeper and more prolonged.

A rapidly acting opioid analgesic which minimizes the duration of respiratory depression is preferred. The amount of analgesic administered should be titrated to the needs of the patient. Non-receptor mediated actions may occur and should be expected (e.g., facial swelling, itching, generalized erythema, or bronchoconstriction) presumably due to histamine release.

Irrespective of the drug chosen to reverse naltrexone hydrochloride blockade, the patient should be monitored closely by appropriately trained personnel in a setting equipped and staffed for cardiopulmonary resuscitation.
PURPOSE: The aim of this study was to describe the importance of symblepharon release with ocular surface reconstruction (OSR) for optimal fitting of scleral contact lenses (SCLs) in eyes with chronic cicatrizing conjunctivitis (CCC) and keratopathy.
METHODS: This retrospective study included 32 eyes with CCC and keratopathy with symblepharon which underwent symblepharon release with OSR and were fitted with SCLs. The primary outcome measure was the improvement in best-corrected visual acuity with SCL wear.
RESULTS: A total of 32 eyes of 29 patients (66% men) with a median age of 30.5 years were included. The common causes of CCC were Stevens-Johnson syndrome (66%) and ocular burns (16%). The most common location of symblepharon was superior (59%) with limbal involvement in most eyes (94%). Symblepharon release was combined with mucous membrane grafting (63%), amniotic membrane grafting (31%), or conjunctival autografting (6%). The median interval between symblepharon release with OSR and SCL trial was 15 weeks [interquartile range (IQR): 6-24]. The median best-corrected visual acuity improved from logMAR 1.5 (IQR: 1.2-1.8) to logMAR 1.2 (IQR: 0.6-1.4) with SCLs after symblepharon release with OSR ( P < 0.001). The median diameter of the SCL used was 15 mm (IQR: 15-16), with a median base curve of 7.9 mm (IQR: 7.9-8). Symblepharon recurrence was noted in 70% of eyes that underwent amniotic membrane grafting; no recurrence was seen with mucous membrane grafting or conjunctival autografting.
CONCLUSIONS: In eyes with CCC with keratopathy and symblepharon, visual rehabilitation is possible with SCLs after symblepharon release with OSR without having to resort to a penetrating corneal procedure.
Subjects will be randomly assigned (1:1) either to treatment or control. Treatment arm will receive the device and use of vBloc Achieve Weight Management Program.
Patients included were those undergoing Milligan-Morgan hemorrhoidectomy under spinal anaesthesia from January 2018 to December 2019. Exclusion criteria were age \< 18 years old, pregnancy and allergy to local anaesthetics. Patients meeting inclusion and exclusion criteria were randomized to undergo an ultrasound-guided pudendal nerve block. Per-protocol all patients received postoperative metronidazole 500 mg for 3 days, laxative, a basis analgesia with NSAID and opioids as needed. Postoperative pain on the visual analogue scale (VAS) at 6, 12, 24 and 48 hours, opioids needed, complications and length of hospital stay were recorded. Patients and ward personnel were not informed about the treatment arm. All Patients were further controlled 6 weeks after the intervention.
Tuberculosis (TB), caused by Mycobacterium tuberculosis, is a leading infectious disease with varied manifestations. We report a rare presentation of gastric TB in a 50-year-old immunocompetent woman from the Middle East with no prior medical history. The patient presented with persistent epigastric pain, weight loss, nausea, and vomiting over a 2-month duration. Imaging studies and an infectious disease panel were inconclusive. However, upper endoscopy revealed a subepithelial lesion at the pylorus, with biopsies demonstrating caseating granuloma and multinucleated giant cells. A QuantiFERON test was subsequently positive for TB. The patient was successfully treated with standard TB quadruple therapy, resulting in significant improvement in symptoms during follow-up. This case underscores the importance of considering extrapulmonary TB in immunocompetent patients with atypical gastrointestinal symptoms and highlights the efficacy of prompt antitubercular therapy.
Health education. Participants take part in 16-week program. The health education includes work, rest, diet and other basic programs according to the different conditions of participants.
Patients included in the experimental arm have treatment adapted to the radiological score. The radiological score described by Berge et al. (Berge et al. Eur J Trauma Emerg Surg 2021) is calculated after patient inclusion.
Patients of either sex over 18 years old with histopathological confirmed melanoma. We will include patients with stage II, III or IV according to the American Joint Committee on Cancer (AJCC) staging.
Study participants will perform 5 x 2 min alternating bilateral contractions of the hand flexor muscles at 30% maximum voluntary contraction with one minute rest between contractions, in a total of 20 minutes training during the period of hospitalization. It will be occur once per day until the hospital exit.
This condition will combine both the highlighting and FOP labeling interventions from conditions 2 and 3. Note: Across the four arms we are essentially doing a 2 (highlighting/no highlighting) by 2 (front of pack warning/ no front of pack warning) within subjects design.
Diagnostic procedures which involve the use of radiopaque diagnostic agents should be carried out under the direction of personnel with the prerequisite training and with a thorough knowledge of the particular procedure to be performed. Appropriate facilities should be available for coping with any complication of the procedure, as well as for emergency treatment of severe reactions to the contrast agent itself. After administration of the radiocontrast agent, competent personnel and emergency facilities should be available for at least 30 to 60 minutes since delayed reactions have occurred (see ADVERSE REACTIONS).

The possibility of an idiosyncratic reaction in susceptible patients should always be considered (see ADVERSE REACTIONS). The susceptible population includes patients with a history of a previous reaction to a contrast medium, patients with a known sensitivity to iodine per se and patients with a known clinical hypersensitivity: bronchial asthma, hay fever and food allergies.

A positive history of allergies or hypersensitivity does not arbitrarily contraindicate the use of a contrast agent where a diagnostic procedure is thought essential, but caution should be exercised (see ADVERSE REACTIONS). Premedication with antihistamines or corticosteroids to avoid or minimize possible allergic reactions in such patients should be considered. Recent reports indicate that such pre-treatment does not prevent serious life-threatening reactions, but may reduce both their incidence and severity.

Since these procedures require instrumentation, special precautions should be observed in those patients known to have an acute urinary tract infection.

Filling of the bladder should be done at a steady rate, exercising caution to avoid excessive pressure. Sterile procedures should be employed in administration.
Evidence-based guidelines for primary care of diabetes have been established and disseminated, yet adoption of guidelines in community-based primary care practice has been disappointing. This effectiveness study proposes a randomized trial involving 54 community-based primary care practices to test two innovative interventions to improve diabetes and depression care. One intervention, derived from theoretically based and efficacious programs tested in other settings, adopts a broad focus and seeks to improve diabetes and depression care by a) increasing the practice's organizational capacity to manage change, and b) implementing and sustaining chronic care office systems that support clinician efforts to improve care for diabetes. The intervention will combine two integrated components. The first component will utilize an Improvement Facilitator that will assess the practice's current use of chronic care office systems and their organizational capacity to manage change, provide feedback to key stakeholders in the practice, and work with the practice over six months to form an Improvement Team that will both address organizational capacity to create and sustain improvement and implement chronic care systems. In the second component of the intervention, the practice will participate in a local Improvement Collaborative that will afford opportunities to learn and share experiences during implementation and maintenance phases of the intervention with five similar practices in their geographic area. The second intervention is based on traditional QI methods and focuses on a chronic disease registry with regular reports to the physicians. It also uses PDSA cycles to assist in implementing change. This intervention will offer tools to improve diabetes and/or asthma care. Both interventions will be evaluated in two ways. First, a randomized trial using rigorous quantitative methods will measure 2 primary and 3 secondary endpoints at 9 and 18 months, including a) the ADA Physician Recognition Program performance measures by both patient-report and review of the medical record, and b) HEDIS measures of acute phase management of depression, c) assessment of the extent to which practices implement and physicians use elements of the chronic care model in their care of diabetes and depression. Change from baseline to 9 months will assess adoption of chronic care improvements, and change from 9 to 18 months will assess sustainability of improvements. Second, a multimethod assessment process will be used to analyze all qualitative and quantitative data separately to understand how and why the intervention led to the observed effects. The practice assessment will strive to understand which components of the interventions were most effective, their relative costs for implementation, and how they might be further improved. Successful components of the intervention will be refined and made available to our collaborators in the project; the Copic Insurance Company and the Colorado Clinical Guidelines Collaborative, for use in their statewide activities to improve diabetes care.
The present invention relates to compositions, in particular for the treatment of hyperthyreosis (also designated hyperthyroidism), especially in cats. These compositions are formulated for transdermal administration of an active substance and may, for example, be applied into the auricle (or pinna) of the cat. They comprise an active agent such as methimazole (or 2-mercapto-1-methylimidazole) or carbimazole, at least one wax, at least one fatty oil, and optionally an emulsifier. As emulsifier a nanocarrier may be used, for example. Unimolecular nanocarriers of dendritic structure are preferred, wherein the nanocarrier comprises a dendritic core and at least two shells, wherein an inner shell is coupled to the dendritic core via a first linker, and an outer shell is coupled to the inner shell via a second linker. In one embodiment, the composition is provided as a stick, in another, a semi-solid formulation in a suitable applicator which may contain one or more dosage units.
The present invention relates to a deer heart blood soft capsule and the preparation process thereof. The deer heart blood soft capsule serves as Chinese traditional medicine used for improving cardiac function. At present, the deer blood product is large in volume, bad in absorption effect, low in medicine effect exertion degree. If the deer blood product is taken for long time, not only is a high hospitalization cost needed but also sometimes other diseases are caused. The deer heart blood soft capsule comprises deer heart blood, which is produced by adopting the following methods: material selection; the deer heart blood is heated, dried and produced into coarse powder; the coarse powder is produced into fine powder which is 5 to 7-micrometer in diameter and equal to that with a particle size ranging from 1250 to 1500 meshes; by adopting an ultramicron high pressure preparation system to carry out an emulsification, raw materials for soft capsule are obtained; the finished product is produced in soft capsule product line and then disinfection and package are performed. The soft capsule serves as heart disease treatment product and health care product.
The safety and effectiveness of fosaprepitant for the prevention of nausea and vomiting associated with HEC or MEC have not been established in patients less than 6 months of age.

Juvenile Animal Toxicity Data

In juvenile dogs treated with fosaprepitant, changes in reproductive organs were observed. In juvenile rats treated with aprepitant, slight changes in sexual maturation were observed without an effect on reproduction. No effects on neurobehavior, sensory and motor function, or learning and memory were observed in rats.

In a toxicity study in juvenile dogs treated with fosaprepitant from postnatal day 14 (equivalent to a newborn human) to day 42 (approximately equivalent to a 2 year old human), decreased testicular weight and Leydig cell size were seen in the males at 6 mg/kg/day and increased uterine weight, hypertrophy of the uterus and cervix, and edema of vaginal tissues were seen in females from 4 mg/kg/day. A study was also conducted in young rats to evaluate the effects of aprepitant on growth and on neurobehavioral and sexual development. Rats were treated at oral doses up to the maximum feasible dose of 1000 mg/kg twice daily from the early postnatal period (Postnatal Day 10 (equivalent to a newborn human) through Postnatal Day 58 (approximately equivalent to a 15 year old human)). Slight changes in the onset of sexual maturation were observed in female and male rats; however, there were no effects on mating, fertility, embryonic-fetal survival, or histomorphology of the reproductive organs. There were no effects in neurobehavioral tests of sensory function, motor function, and learning and memory.

Pediatric use information is approved for Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.’s Emend (fosaprepitant) for injection. However, due to Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Hormone receptor (HR) positive and human epidermal growth factor receptor-2 (HER-2) positive breast cancer has the characteristics of mild biological behavior and slow progression. Currently, capecitabine combined with pyrotinib is the standard protocol for this kind of advanced breast cancer after trastuzumab failure, and the median progression free survival (PFS) is 11.0 months. The incidence of grade 3 hand-foot-syndrome was 16.4%, the incidence of grade 3 diarrhea was 30.6%, and the incidence of grade 3 myelosuppression was 6%. Therefore, the search for efficient and low toxicity alternatives has become a research hotspot.

Our previous basic studies have shown that ER inhibitor fulvestrant and HER2 inhibitor pyrotinib have synergistic effect in inhibiting the proliferation of HR + / HER2 + breast cancer cells. At the same time, the preliminary analysis of our prospective, phase II, single arm study of "Fulvestrant combined with Pyrotinib in the treatment of HR + / HER2 + advanced breast cancer" shows that the efficacy is close to that of capecitabine combined with pyrotinib (median progression free survival is more than 13 months), and the adverse events are significantly improved compared with capecitabine combined with pyrotinib (grade 3 hand-foot-syndrome). This project has been supported by the "Sun-yat sun clinical research and cultivation project" of Sun-Yat Sen Memorial Hospital, Sun-Yat Sen University. Therefore, it is necessary to further carry out a head-to-head phase III randomized controlled clinical trial to study the efficacy and safety of fulvestrant combined with pyrotinib in the treatment of HR + / HER2 + advanced breast cancer, with a non-inferiority cut-off value of HR = 1.30. Combined with the analysis of biomarkers, to find the molecular indicators to predict the benefit of pyrotinib combined with endocrine therapy, so as to provide theoretical basis for guiding precise treatment.