anthonyyazdaniml/gliner-biomed-curated-corpus huggingface dataset:
Adult and Pediatric Patients ages 4 years and older

The effectiveness of BANZEL as adjunctive treatment for the seizures associated with Lennox-Gastaut Syndrome (LGS) in adult and pediatric patients ages 4 years and older was established in a single multicenter, double-blind, placebo-controlled, randomized, parallel-group study (N=138). Male and female patients (between 4 and 30 years of age) were included if they had a diagnosis of inadequately controlled seizures associated with LGS (including both atypical absence seizures and drop attacks) and were being treated with 1 to 3 concomitant stable dose AEDs. Each patient must have had at least 90 seizures in the month prior to study entry. After completing a 4-week Baseline Phase on stable therapy, patients were randomized to have BANZEL or placebo added to their ongoing therapy during the 12 -week Double-blind Phase. The Double-blind Phase consisted of 2 periods: the Titration Period (1 to 2 weeks) and the Maintenance Period (10 weeks). During the Titration Period, the dose was increased to a target dosage of approximately 45 mg/kg per day (3200 mg in adults of > 70 kg), given on a twice daily schedule. Dosage reductions were permitted during titration if problems in tolerability were encountered. Final doses at titration were to remain stable during the maintenance period. Target dosage was achieved in 88% of the BANZEL-treated patients. The majority of these patients reached the target dose within 7 days, with the remaining patients achieving the target dose within 14 days.

The primary efficacy variables were:

  * The percent change in total seizure frequency per 28 days;  

  * The percent change in tonic-atonic (drop attacks) seizure frequency per 28 days;  

  * Seizure severity from the Parent/Guardian Global Evaluation of the patient’s condition. This was a 7-point assessment performed at the end of the Double-blind Phase. A score of +3 indicated that the patient’s seizure severity was very much improved, a score of 0 that the seizure severity was unchanged, and a score of -3 that the seizure severity was very much worse.



The results of the three primary endpoints are shown in Table 7 below.

Pediatric Patients ages 1 to less than 4 years

The effectiveness of BANZEL as adjunctive treatment for the seizures associated with Lennox-Gastaut Syndrome in pediatric patients ages 1 year to less than 4 years was established based on a single multi-center, open-label, active-controlled, randomized, pharmacokinetic bridging study. The pharmacokinetic profile of BANZEL is not significantly affected by age either as a continuous covariate (1 to 35 years) or as a categorical covariate (age categories: 1 to less than 4 years and 4 years of age and older), after body weight is taken into consideration.
Dextrose Injection, 5% and 10% USP are sterile, non-pyrogenic solutions of Dextrose, USP in Water for Injection in a polyvinylchloride flexible plastic container for intravenous administration as a source of water and calories.

Partial-fill containers, designed to facilitate admixture when necessary, are available in 25 mL, 50 mL, 100 mL, 250 mL, 500 mL, and 1000 mL sizes. See Table 1 for the content and characteristics of this solution.

The solution contains no bacteriostatic, antimicrobial agent or added buffer and is intended only for use as a single-dose injection. The pH range is 4.0 (3.2 to 6.5).

Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly.

Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6 • H2O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula:

Water for Injection, USP is chemicaly designated H2O.

Dextrose is derived from corn.

The VIAFLEX Plus plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). VIAFLEX Plus on the container indicates the presence of a drug additive in a drug vehicle. The VIAFLEX Plus plastic container system utilizes the same container as the VIAFLEX plastic container system. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.
Pseudomonas aeruginosa is a versatile opportunistic pathogen which causes a variety of acute and chronic human infections, some of which are associated with the biofilm phenotype of the pathogen. We hypothesize that defining the intracellular metabolome of biofilm cells, compared to that of planktonic cells, will elucidate the metabolic pathways and biomarkers indicative of biofilm inception. Disc-shaped stainless-steel coupons (12.7 mm diameter) were employed as a surface for static biofilm establishment. Each disc was immersed in a well, of a 24-well microtiter plate, containing a 1-mL Lysogeny broth (LB) suspension of P. aeruginosa ATCC 9027, a strain known for its biofilm prolificacy. This setup underwent oxygen-depleted incubation at 37°C for 24 hours to yield hypoxic biofilms and the co-existing static planktonic cells. In parallel, another planktonic phenotype of ATCC 9027 was produced in LB under shaking (200 rpm) incubation at 37°C for 24 hours. Planktonic and biofilm cells were harvested, and the intracellular metabolites were subjected to global untargeted metabolomic analysis using LC-MS technology, where small metabolites (below 1.5 kDa) were selected. Data analysis showed the presence of 324 metabolites that differed (p < 0.05) in abundance between planktonic and biofilm cells, whereas 70 metabolites did not vary between these phenotypes (p > 0.05). Correlation, principal components, and partial least square discriminant analyses proved that the biofilm metabolome is distinctly clustered away from that of the two planktonic phenotypes. Based on the functional enrichment analysis, arginine and proline metabolism were enriched in planktonic cells, but butanoate metabolism was enriched in biofilm cells. Key differential metabolites within the butanoate pathway included acetoacetate, 2,3-butandiol, diacetyl, and acetoin, which were highly upregulated in the biofilm compared to the planktonic cells. Exogenous supplementation of acetoin (2 mM), a critical metabolite in butanoate metabolism, augmented biofilm mass, increased the structural integrity and thickness of the biofilm, and maintained the intracellular redox potential by balancing NADH/NAD+ ratio. In conclusion, P. aeruginosa hypoxic biofilm has a specialized metabolic landscape, and butanoate pathway is a metabolic preference and possibly required for promoting planktonic cells to the biofilm state. The butanoate pathway metabolites, particularly acetoin, could serve as markers for biofilm development.
Do not use unless adequate proctologic examination is made.

If irritation develops, the product should be discontinued and appropriate therapy instituted.

In the presence of an infection, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the hydrocortisone acetate should be discontinued until the infection has been adequately controlled.

Carcinogenesis: No long term studies in animals have been performed to evaluate the carcinogenic potential of corticosteroid suppositories.

Pregnancy Category C: In laboratory animals, topical steroids have been associated with an increase in the incidence of fetal abnormalities when gestating females have been exposed to rather low dosage levels. There are no adequate and well controlled studies in pregnant women. Hydrocortisone Acetate Suppositories should only be used during pregnancy if the potential benefit justifies the risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

It is not known whether this drug is excreted in human milk and because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Hydrocortisone Acetate Suppositories, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Globally, lung cancer accounts for the most cancer deaths in both sexes combined. It is believed to develop slowly through progressive accumulation of genetic mutations, hence the disease allows time for diagnosis and curative surgical treatment. Five year survival rates for non-small-cell lung carcinoma (NSCLC) can range from 57-61% when detected in the early stages of disease. This is compared with a survival rate of approximately 6% once distant metastases are present. However, disease diagnosis typically occurs when it has progressed to an advanced stage when patients present with signs and symptoms. Therefore, technologies capable of asymptomatic disease detection will significantly impact lung cancer specific mortality. Metabolomic profiling of cancer measures compounds produced as a result of cellular activity including volatile organic compounds (VOCs) in exhaled breath. Infrared spectroscopy is a proven technique for breath analysis that can measure chemical concentrations in the parts per trillion range for certain VOCs. When coupled with machine learning techniques, this has the potential to be a novel approach for disease detection using exhaled breath.
The IDH1 peptide vaccine is a 20mer peptide encompassing the IDH1R132H-mutated region emulsified in Montanide®. It is injected subcutaneously and administered in combination with topical imiquimod. The vaccine is administered 8 times every 2 or 4 weeks.
Spontaneous intracerebral hemorrhage is a major cause of disability and mortality among different types of stroke, and few effective treatment options are available. Therefore, it is essential to develop new approaches to improve the prognosis of these patients. Recently, remote ischemic conditioning (RIC), a method that involves inducing multiple brief episodes of ischemia and reperfusion in the limbs, has been indicated to exert neuroprotective effects in experimental stroke. The underlying neuroprotective mechanism triggered by RIC induces gene expression, alters pathways, promotes neurogenesis and blood vessel development, reduces oxidative stress and neuronal apoptosis, and inhibits proinflammatory signals. Previously, several clinical trials have shown that single or repeated RIC treatments for cerebrovascular diseases are feasible and safe. Therefore, we hypothesize that RIC could improve functional outcome in patients with intracerebral hemorrhage. We design this prospective, multicenter, randomized controlled trial to evaluate the efficacy and safety of RIC in treating intracerebral hemorrhage.
Traumatic brain injury (TBI) is a major cause of morbidity and mortality in Bangladesh and also worldwide. Secondary brain injury from progressive intracerebral hematoma, increasing cerebral edema, raised intracranial pressure and subsequent cerebral ischemia is the main cause for morbidity and mortality following TBI. Secondary brain injury is worsened by post-traumatic coagulopathy, which occurs in brain injured patients and is associated with increase in risk of death and morbidity. The antifibrinolytic agent tranexamic acid (TXA) reduces the hematoma expansion and demonstrated improved clinical outcome also reduced the mortality and morbidity. This was a randomized controlled trial (RCT) done in the Department of Neurosurgery, Dhaka Medical College and Hospital. Included patients were randomized to get either the intravenous tranexamic acid (Group A) or placebo (Group B) treatment based on a computer-generated code list (50 patients in each group) along with usual medical management for traumatic brain injury. The extent of contusion expansion (hematoma plus perihematomal oedema) as the primary outcome at 48 hour after admission and was measured by brain CT scan. The contusion and oedema volume were calculated both the times (on admission and after 48 hours). Glasgow coma scale (GCS) after 48 hours and Glasgow outcome scale (GOS) after 7 days were observed. In this study showed increase in hematoma volume in both groups (p<0.05). But the increased hematoma volume in the Group A was significantly less than that in the control group. The mean total hemorrhage expansion was (1.5±1.1) ml and (4.6±1.9) ml in the Group A and Group B, respectively. In Group A- 02(4.0%) patients required operation, whereas in Group B- 11(22.0%) patients required operation. The result was significant (p=0.023) between groups. Therefore use of tranexamic acid is associated with lesser hematoma volume progression. Mean GCS (after 48 hours), mean GOS (after 7 days) result were significantly better in Group A (p<0.001). This study concluded that tranexamic acid has beneficial effect on the patient with significant traumatic brain injury. Tranexamic acid helps in reduction of intracerebral progression of contusion and improvement of clinical outcomes in patients with TBI.
FIELD: paper.SUBSTANCE: invention can be used in the manufacture of paper, paints, polymer compositions. Method of manufacturing an aqueous suspension of precipitated calcium carbonate includes the provision of a material containing calcium oxide and at least one depolymerized carboxylated cellulose having a Mmolecular weight in the range from 10,000 to 40,000 g/mol. Water containing calcium oxide material and at least one depolymerized carboxylated cellulose are mixed to produce milk of lime. In this case, the depolymerized carboxylated cellulose is present in the form of a solution containing a solid in an amount of from 10 to 60 wt. % with respect to the total weight of the solution, and/or added in an amount of from 0.001 to 5 wt. % with respect to the total mass of calcium oxide-containing material in the milk of lime. Material containing calcium oxide and water is mixed in a mass ratio of from 1:1 to 1:1. This is followed by carbonization of milk of lime with the formation of an aqueous suspension of precipitated calcium carbonate.EFFECT: invention allows to obtain an aqueous suspension of precipitated calcium carbonate with a high solids content without an additional stage of separation or concentration.13 cl, 1 dwg, 2 tbl, 3 ex
Described herein is a physiologically balanced, ionized, acidic solution, typically prepared by the electrolysis of a solution comprising a mixture of inorganic salts in physiologically balanced proportions. This invention also relates to the use of the solutions. A mixture of inorganic salts and, optionally minerals, (such as metallic elements) is used in order to mimic the electrolyte concentration and mixture of body fluid in an isotonic state. The solution typically comprises halide salts of sodium, potassium, calcium, and other cations. Typically the halide is fluoride, chloride, bromide, or iodide. A typical electrolyzed solution of the invention has a pH within the range of about 2 to about 6, an oxidation reduction potential within the range of about +600 mV to about +1200 mV, and a titratable halide content within the range of about 10 ppm to about 100 ppm. The pH of the electrolyzed, chlorine-comprising solution is typically lowered to about 6 or less, giving the solution bactericidal, fungicidal, and sporicidal properties. The composition is nontoxid and is useful in any application in which antimicrobial properties are desirable. The composition can be incorporated into a bandage or wound dressing, preferably, a specialized bandage which can be opened and closed, and through which topical treatment materials such as the solution of the present invention may be applied.
After the safety and tolerability for cohort 1 has been evaluated, participants will receive 1 mg/kg of XmAb22841 (CTLA-4 X LAG3) in combination with 10 mg/kg of XmAb23104 (PD1 X ICOS) on days 1 \& 15 of a 28 day cycles for up to 4 cycles. After Cycle 4, participants will receive 10 mg/kg of XmAb23104 (PD1 X ICOS) monotherapy up to an additional 20 cycles. Participants may receive treatments up to 24 total cycles, or until unacceptable toxicity or progressive disease; whichever comes first.
The patients with unexplained primary (no previous successful pregnancy) recurrent miscarriage (RM) referred to the Hungaria Center for Endocrinology and Reproductive Medicine between January 2000 to January 2007 were considered eligible for the study. The patients had to fulfil the following inclusion criteria: woman's age less than 39 years, more than 4 previous abortions, failure of a previous treatment for RM (immunoglobulin infusion), and they had to be negative for the all the known causes of RM The study was reviewed and approved by the Institutional Review Board, and the clinical study was conducted according to Italian law and the Declaration of Helsinki for Medical Research involving Human Subjects. A sample size calculation showed that a total of 32 patient per group were needed in order to have a difference of 33% between the two groups a for p\<0.005 and a beta\>0.80 A total of 72 patients were considered eligible for the study, and 68 of them agreed to participate, signing an informed consent form. All the patients were informed about the eventual potential risks of this treatment for the mother and the foetus, other than the lack of information about the developmental toxicity of G-CSF. The patients were randomized by means of a computer generated randomization number sequence. All the patients were informed about the therapy and they gave their written informed consent. They were randomly assigned to the two arms of the study, one to G-CSF treatment and the other to placebo administration; the patients were blind to which treatment they were assigned to. The G-CSF group of 35 women, underwent a daily sub-cutaneous administration of the filgrastim (Neupogen, Dompe', Italy), the recombinant G-CSF, at a dosage of 1 microgram (100000 IU)/kg/day from the 6th day after ovulation till the occurrence of menstruation or to the end of the 9th week of gestation. The placebo group consisting of 33 subjects, was given a treatment with subcutaneous saline solution at the dosage of 0.2 ml daily, and also in this case, from the 6th day after the ovulation till to the recurrence of menstrual loss or to the end of the 9th week. Primary outcome was considered the pregnancy outcome.
After explaining and taking consent from the patient about the intervention, pre intervention assessment will be made. Silicone gel sheet (Rystoraº) will be used at scar wound for 16 hours every day for 3 months. After 3 months post intervention assessment will be made.
NEW MATERIAL:Pentaerythritol sulfuric ester polyaluminum hydroxide complex or dipentaerythritol sulfuric ester polyaluminum hydroxide complex. USE:An antiulcer. Having improved stability. PREPARATION:For example, dipentaerythritol is reacted with sulfuric anhydride- pyridine complex in a dried pyridine solvent at 80-90 deg.C with stirring. An oily substance which is precipitated after cooling is dissolved in distilled water, neutralized with 10wt% NaOH solution under cooling with ice, adjusted to a proper pH, and concentrated. Ethanol is added to the solution, to give precipitate of sodium dipentaerythritol sulfate. Then, 1mol of this compound is reacted with 3-3.5mol basic polyaluminum chloride complex (polymer having 0.67-0.83 basicity obtained by reacting metal Al with AlCl3 in an aqueous solution) in distilled water with stirring.
In a placebo-controlled clinical trial of patients with RA, no difference was detected in anti-pneumococcal antibody response between adalimumab and placebo treatment groups when the pneumococcal polysaccharide vaccine and influenza vaccine were administered concurrently with adalimumab. Similar proportions of patients developed protective levels of anti-influenza antibodies between adalimumab and placebo treatment groups; however, titers in aggregate to influenza antigens were moderately lower in patients receiving adalimumab. The clinical significance of this is unknown. Patients on AMJEVITA may receive concurrent vaccinations, except for live vaccines. No data are available on the secondary transmission of infection by live vaccines in patients receiving adalimumab products.

It is recommended that pediatric patients, if possible, be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating AMJEVITA therapy. Patients on AMJEVITA may receive concurrent vaccinations, except for live vaccines.

The safety of administering live or live-attenuated vaccines in infants exposed to adalimumab products in utero is unknown. Risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants [see Use in Specific Populations (8.1, 8.4)].
The invention relates to an oral hygiene means with improved cleaning properties. It may be in the form of toothpaste, cleaning gum, water mouthwash, and powder for cleaning teeth and dental prostheses. The active component contained in the means is clynoptilolite modified to a particle size less or egual to 0.1 mm, thermally treated, dehydrated and sterilized at a temperature of 200 to 250 degrees C for 2 hours and more. The toothpaste consists of conventionally used active components, aromatizers, sweeteners, coloring agents, fillers, and modified clynoptilolite from 1 to 10 weight percent. The toothpowder consists of known ingredients, aromatizers, sweeteners, coloring agents, and modified clynoptilolite from 1 to 50 weight percent. The gum comprises known ingredients, aromatizers, sweeteners, coloring agents, and modified clynoptilolite from 1 to 5 weight percent. The powder for cleaning dental prostheses contains sodium bicarbonate and modified clynoptilolite in a 1:1 ratio. The water mouthwash contains water, known active ingredients, aromatizers, sweeteners, coloring agents, and modified clynoptilolite from 0.1 to 1 weight percent with a particle size less or egual to 0.01 mm.
The invention discloses a co-crystal of famotidine and adipic acid and a preparation method thereof. The co-crystal is a hydrate containing one molecule of water, and the molar ratio of famotidine to adipic acid is 2: 1. Also disclosed is a method for preparing the co-crystal. The famotidine-adipic acid eutectic provided by the invention has characteristic melting points, X-ray powder diffraction patterns and the like. The eutectic improves the solubility of famotidine in water, improves the stability of famotidine under high-temperature and high-humidity conditions, and has the potential of improving the bioavailability of famotidine. The preparation method of the famotidine-adipic acid eutectic is simple in steps, easy to operate, good in reproducibility and high in commercial application value.