anthonyyazdaniml/gliner-biomed-curated-corpus huggingface dataset:
Patients with Partial-Onset or Primary Generalized Tonic-Clonic Seizures

Adults and Pediatric Patients 10 Years of Age and Older

The effectiveness of TOPAMAX ® as initial monotherapy in adults and pediatric patients 10 years of age and older with partial-onset or primary generalized tonic-clonic seizures was established in a multicenter, randomized, double-blind, parallel-group trial (Study 1). 

Study 1 was conducted in 487 patients diagnosed with epilepsy (6 to 83 years of age) who had 1 or 2 well-documented seizures during the 3-month retrospective baseline phase who then entered the study and received TOPAMAX ® 25 mg/day for 7 days in an open-label fashion. Forty-nine percent of patients had no prior AED treatment and 17% had a diagnosis of epilepsy for greater than 24 months. Any AED therapy used for temporary or emergency purposes was discontinued prior to randomization. In the double-blind phase, 470 patients were randomized to titrate up to 50 mg/day or 400 mg/day. If the target dose could not be achieved, patients were maintained on the maximum tolerated dose. Fifty-eight percent of patients achieved the maximal dose of 400 mg/day for >2 weeks, and patients who did not tolerate 150 mg/day were discontinued. 

The primary efficacy assessment was a between-group comparison of time to first seizure during the double-blind phase. Comparison of the Kaplan-Meier survival curves of time to first seizure favored the TOPAMAX ® 400 mg/day group over the TOPAMAX ® 50 mg/day group (Figure 1). The treatment effects with respect to time to first seizure were consistent across various patient subgroups defined by age, sex, geographic region, baseline body weight, baseline seizure type, time since diagnosis, and baseline AED use. 

Pediatric Patients 2 to 9 Years of Age

The conclusion that TOPAMAX ® is effective as initial monotherapy in pediatric patients 2 to 9 years of age with partial-onset or primary generalized tonic-clonic seizures was based on a pharmacometric bridging approach using data from the controlled epilepsy trials described in labeling. This approach consisted of first showing a similar exposure response relationship between pediatric patients down to 2 years of age and adults when TOPAMAX ® was given as adjunctive therapy. Similarity of exposure-response was also demonstrated in pediatric patients 6 to less than 16 years of age and adults when TOPAMAX ® was given as initial monotherapy. Specific dosing in pediatric patients 2 to 9 years of age was derived from simulations utilizing plasma exposure ranges observed in pediatric and adult patients treated with TOPAMAX ® initial monotherapy [see Dosage and Administration (2.1)] .
Procedure for preparing triglycerid mixtures. It is part of rich raw materials in monoinsaturates of the haxadecanoic, octodecanoico and octodecenoico acids. The grease is dissolved in an appropriate organic solvent and by crystallization and filtration at different temperatures, three fractions are insulated. The first fraction, with a fusion point above 55 degrees c, includes, majority, triglycerides of saturated fatty acids; of utility in the chemical-pharmaceutical and nutrition industry. The second fraction with mixed triglycerides, funde between 30 degrees c and 40 degrees c; it is used for the manufacture of suppositories and for human nutrition. The third and last fraction funde at less than 30 degrees c and is constituted by glycerides of the acids cited; suitable for dietary food regimes that tend to decrease hemical cholesterol. (Machine-translation by Google Translate, not legally binding)
Care as usual may include all mental health care that is usually provided within or outside (e.g., at a child mental healthcare institution or at school) the general practitioners practice, except from pharmacological treatment for children's behavioral difficulties and/or behavioral parent training/support, up until the first posttreatment assessment (T1). Care as usual can also imply that there is no support or treatment.
Humans have evolved as a diurnal species, internally governed by the circadian system, which dictates our hormone regulation. 'Chrononutrition' is a sub-discipline which combines food timing with circadian physiology. The most popular method of time-restricted feeding in the UK is to skip breakfast. However, data from several meta-analysis have shown that skipping breakfast is associated with weight gain and insulin resistance, likely due to eating later into the evening/night and therefore, out of sync with our circadian rhythm. Recent research has shown that skipping dinner (evening fasting) has improved markers of cardio-metabolic health in clinical populations, although these are typically from longer-term studies. Despite these promising findings, it is not yet known whether these findings are population specific.

Therefore, the investigators are interested in examining the metabolic response pre and post-intervention to see whether these promising findings can translate into a healthy population. Furthermore, the investigators will be monitoring subjective appetite, energy intake, and expenditure to assess whether there is any short-term adaptation to a specific feeding window.
The present invention discloses an acne treating Chinese medicine preparation, which is mainly prepared from various traditional Chinese medicines, such as rehmannia roots, lilyturf roots, stir-fried mulberry root bark, sweet wormwood, stir-fried loquat leaves, Chinese yams, Chinese angelica roots, flavescent sophora roots, dittany bark, plantain seeds, flitilarry bulbs, coptis, phellodendron bark, prism tuber, zedoary, notoginseng powder, etc., according to a certain weight proportion. The present invention can be prepared into any one of conventional orally taken preparation forms. Through the mutual action of various carefully selected traditional Chinese medicines with the functions of nourishing kidneys, nourishing yin, promoting blood circulation to disperse blood clots, clearing heat and detoxicating, the present invention has the functions of regulating organism endocrine, maintaining sex hormone balance in vivo, promoting sebum metabolism and inhibiting bacterium growing. The present invention has the advantages of obvious therapeutic action, convenience for taking in and no toxic or side effect. The present invention has a unique effect on treating acne of various types, an obvious effect can be obtained for patients with mild acne and moderate acne through the treatment of 1 to 2 weeks, and the acne can be cured in 3 to 4 weeks; patients with severe acne can obtain recovery in 5 to 8 weeks. The present invention has the efficacy of nourishing yin, promoting the production of the body fluid, clearing away heat and toxic materials, promoting blood circulation and dissipating blood stasis. The present invention has the advantages of quick effect on treating acne and high cure rate.
: Diabetic peripheral neuropathy is one of the common complication of chronic diabetes mellitus, with a 30-50 % prevalence. Progressive development of pain, numbness in toes or feet and sensory motor disorders affects the patient's quality of life. The epidemic spread of the disease has raised concern among physicians and researchers. A variety of agents or medicines with potential effect have been studied to control development of peripheral neuropathy. The existing management are yet unsatisfactory. Recent studies have suggested that L-carnitine is potential to alleviate symptoms in patents with diabetic neuropathy. Previous trial also indicated the efficacy and safety of L-carnitine on diabetic neuropathy. This limitations have led to search for an effective and tolerable option by placebo controlled trial.The present study is an attempt to investigate the effects of carnitine on pain and symptom improvement of diabetic peripheral neuropathy.
A 12-week intervention program that consists of walking every day (the time is individually adjusted) and exercising 3 times a week. Shared features of the different programs are the inclusion of resistance, cardiovascular, balance and flexibility components. All exercises will be individually tailored. Once-per-week, subjects assigned to this group will attend the primary care center to execute one of the three exercise sessions per week under the supervision of the physical therapist.
NEW MATERIAL:A compound shown by the formula I . USE:A (6R) derivative is a remedy for phenylketonuria, etc. It has high crystallinity, easily purified, and obtained in high yield. PREPARATION:L-Erythro-biopterin is catalytically reduced preferably in 0.1- 20wt% basic medium (e.g., an aqueous solution of potassium carbonate) in the presence of 1-50wt% platinum catalyst (based on biopterin), the reaction solution is acidified with sulfuric acid, concentrated, and purified to give a sulfate of the compound shown by the formula I . The sulfate is a mixture (6R) derivative and (6S) derivative, rich in (6R) derivative, it is subjected to separation crystallization with a water-alcohol mixed solution (an amount of alcohol is preferably 5-50vol% based on water) or the mixed solution containing a mineral acid, to obtain a sulfate of (6R) derivative shown by the formula II. The concentration of the sulfate is preferably 0.1-20wt%, and that of the mineral acid is preferably 1-10wt%.
Lithium may cause fetal harm when administered to a pregnant woman. There have been reports of lithium having adverse effects on nidations in rats, embryo viability in mice, and metabolism in-vitro of rat testis and human spermatozoa have been attributed to lithium, as have teratogenicity in submammalian species and cleft palates in mice. Studies in rats, rabbits and monkeys have shown no evidence of lithium-induced teratology. Data from lithium birth registries suggest an increase in cardiac and other anomalies, especially Ebstein’s anomaly. If the patient becomes pregnant while taking lithium, she should be apprised of the potential risk to the fetus. If possible, lithium should be withdrawn for at least the first trimester unless it is determined that this would seriously endanger the mother.
The human Cytomegalovirus (CMV) is found in blood, tissues and nearly all secretory fluids of infected persons. Transmission can be oral, sexual, via blood transfusion, organ transplantation, intrauterine, or perinatal. Infection with CMV preadolescence frequently leads to an asymptomatic infection followed by a lifelong persistence of the virus in the body. Infection post adolescence typically leads to symptoms that resemble those of mononucleosis (e.g., fever, fatigue, hepatitis, etc.) In contrast, CMV infections in immune compromised patients can be life threatening. A major cause of virus-associated morbidity and mortality in solid organ transplantation patients is illness caused by CMV (i.e., CMV syndrome or CMV disease).

The risk of progressing to CMV disease post-transplant is strongly correlated with the serological status of the donor (D) and recipient (R); the highest risk group is R-/D+. Patients at risk for CMV disease can be managed either preemptively (i.e., patients are only treated with antiviral agents after evidence of CMV infection arises), or prophylactically (i.e., all patients are treated with antiviral agents regardless of CMV infection status). Monitoring of the CMV viral load of transplant patients during antiviral therapy provides an effective aid in the management of patients with CMV disease. The artus® CMV RG PCR test is a nucleic acid amplification-based assay for the quantitation of CMV DNA using PCR in the Rotor-Gene™ 6000 Instrument (also known as Rotor-Gene Q) with software version 2.0.2.3 or higher. In the present study the artus CMV RG PCR test result will be evaluated for its ability to safely and effectively monitor transplant patients during antiviral therapy and will be compared to the COBAS® AmpliPrep/COBAS® TaqMan® CMV Test
PURPOSE:To obtain the titled factor, by cloning cDNA coding human necrotic factor with a cloned DNA coding a rabbit cancer necrotic factor as a probe, integrating the resultant cloned cDNA in a plasmid, transforming a microorganism with the plasmid, and using the transformant microorganism. CONSTITUTION:A human macrophage is collected from an air cell, blood or abdominal cavity, etc. and cultivated in an inducer, e.g. endotoxin, to separate a fraction containing a human cancer nectrotic factor mRNA from the above-mentioned cell. A single-stranded cDNA is prepared from the above-mentioned mRNA with a reverse transcriptase, and converted into a double-stranded cDNA, which is inserted into a vector. The resultant vector is then transformed to a host to prepare a cDNA library. A cDNA coding a human cancer necrotic factor is cloned from the above-mentioned cDNA library with a DNA coding a rabbit cancer necrotic factor as a probe, and a microorganism transformed by a plasmid having the integrated cloned DNA is used to give the aimed factor, e.g. a polypeptide having amino acid sequence expressed by the formula.
At the Screening Visit (SV), written informed consent will be obtained from the subject by the Investigator or designee before the performance of any other protocol-specific procedure. The Investigator will select the Index (study) ulcer. Each subject will have only one DFU selected as the Index (study) ulcer. If the subject has more than one ulcer at the SV, the Investigator will select the largest ulcer that meets the eligibility criteria of the protocol as the Index (study) ulcer.The SV is designed to determine whether subjects are eligible to proceed to the Treatment Phase of the study. Those subjects who meet the eligibility criteria will transition to Treatment Visit 1 (TV1) on the same day as the SV.

Subjects who meet eligibility criteria at the SV will receive Meso Wound Matrix (DSM Biomedical, Exton, PA) and standard of care. During the Treatment Phase, subjects will be evaluated on a weekly basis. Efficacy evaluations each week will include Investigator assessment of ulcer healing and measurements of ulcer size using digital photographic planimetry. Safety evaluations during the Treatment Phase will consist of adverse event assessments at each visit. Subjects may receive up to eight applications of Meso Wound Matrix. Subjects whose study ulcer does not heal after eight applications will receive only SOC treatment for 4 additional weeks. Subjects whose ulcers do not achieve closure at or by 12 weeks or who experience an amputation will be deemed treatment failures.
Dose of AR-13503 Implant 63.6 Dose (63.6 µg) administered into a single eye of up to 5 subjects (DME) who will be followed for 24 weeks. Subjects may qualify to receive an additional dose at Week 12.
This study will include an intensive phase for 6 weeks and a follow-up phase that will occur through the final 6 months of the study. Participants will attend one 1-hour orientation meeting at the beginning of the study and a 2-hour baseline assessment and training meeting. A final assessment will be conducted at the end of 6 weeks with a follow-up assessment at 6 months. Everyone in the study will be asked to listen to 2 podcasts per week. Each of the podcasts will take about 15-20 minutes to listen to and so participants should expect to spend 30-40 minutes each week listening to podcasts. Participants also will be randomized to track diet with one of the two mobile dietary tracking applications that will be used in the study. Participants will be encouraged to monitor their exercise and body weight.
Subjects placed into this group will undergo a combined electrical stimulation and eccentric exercise intervention following ACLr. The electrical stimulation intervention will be delivered immediately following ACLr and will end at 6 weeks post-ACLr. Subjects will receive the electrical stimulation therapy 2 times per week for the first 6 weeks post-ACLr. At six weeks post-ACLr, subjects will begin the eccentric strengthening protocol. Subjects will eccentrically train 2 times per week for 6 weeks. The eccentric strengthening will end at 12 weeks post-ACLr.
Study participants (i.e., teachers and students) will be recruited from six districts in southwestern Uganda. The sample will include 12 government-aided secondary schools from which 60 students and 15-25 teachers will be recruited. The final sample will have 720 students and 180-300 teachers. Investigators will assess data in the baseline (i.e., prior to intervention) and three months after the intervention.

Study measures will cover the following topics: socio-demographic data, common disciplinary measure used at home and at school, students' mental health problems, students' and teachers' attitudes towards violent discipline measures, and students' exposure to peer and sexual violence. Questionnaire for teachers will have additional items that measure attitudes towards teaching and teacher stress. Additionally, the investigators will also assess the demand, acceptance and feasibility of the training.
The accumulation of lipid droplets (LDs) and ceramides (Cer) is linked to non-alcoholic fatty liver disease (NAFLD), regularly co-existing with type 2 diabetes and decreased immune function. Chronic inflammation and increased disease severity in viral infections are the hallmarks of the obesity-related immunopathology. The upregulation of neutral sphingomyelinase-2 (NSM2) has shown to be associated with the pathology of obesity in tissues. Nevertheless, the role of sphingolipids and specifically of NSM2 in the regulation of immune cell response to a fatty acid (FA) rich environment is poorly studied. Here, we identified the presence of the LD marker protein perilipin 3 (PLIN3) in the intracellular nano-environment of NSM2 using the ascorbate peroxidase APEX2-catalyzed proximity-dependent biotin labeling method. In line with this, super-resolution structured illumination microscopy (SIM) shows NSM2 and PLIN3 co-localization in LD organelles in the presence of increased extracellular concentrations of oleic acid (OA). Furthermore, the association of enzymatically active NSM2 with isolated LDs correlates with increased Cer levels in these lipid storage organelles. NSM2 enzymatic activity is not required for NSM2 association with LDs, but negatively affects the LD numbers and cellular accumulation of long-chain unsaturated triacylglycerol (TAG) species. Concurrently, NSM2 expression promotes mitochondrial respiration and fatty acid oxidation (FAO) in response to increased OA levels, thereby shifting cells to a high energetic state. Importantly, endogenous NSM2 activity is crucial for primary human CD4+ T cell survival and proliferation in a FA rich environment. To conclude, our study shows a novel NSM2 intracellular localization to LDs and the role of enzymatically active NSM2 in metabolic response to enhanced FA concentrations in T cells.
Manifestations of acute overdosage include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, and panic states. Fatigue and depression usually follow the central stimulation. Cardiovascular effects include tachycardia, arrhythmia, hypertension or hypotension, and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea and abdominal cramps. Overdosage of pharmacologically similar compounds has resulted in fatal poisoning usually terminates in convulsions and coma. 

Management of acute phentermine hydrochloride intoxication is largely symptomatic and includes lavage and sedation with a barbiturate. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendations in this regard. Acidification of the urine increases phentermine excretion. Intravenous phentolamine (Regitine®, CIBA) has been suggested on pharmacologic grounds for possible acute, severe hypertension, if this complicates overdosage.
To achieve the aims of this study, the investigators will perform a randomized clinical trial comparing thromboelastography with standard intraoperative monitoring of coagulation pathways in pediatric neuromuscular deformity surgery. All patients will receive the standard of care hematological management, including intravenous tranexamic acid (50mg/kg loading bolus, 5mg/kg/hr infusion until wound closure) during surgery. Patients randomized to the TEG group will receive standard of care plus TEG tests at four time points: at the time of incision, at completion of surgical exposure, at completion of instrumentation, and upon arrival to the PACU. TEG results will be used to guide fluid replacement, in the form of platelets, fresh frozen plasma, cryoprecipitate, or more tranexamic acid according to previously published protocols9. Data collected will include standard preoperative demographic data: gender, age, body mass index, diagnosis; standard spinal deformity radiographic measurements; and surgical data including operative time, estimated blood loss, and blood product replacement. The international normalized ratio (INR) will be obtained at wound closure, along with a complete blood count, for both groups as per standard of care. Postoperative data points collected will include allogeneic packed red cell transfusion volume, drain output (all drains discontinued on postoperative day #3), time to normal feeding (either home feeding tube rate or normal per os diet), and time to discharge. Perioperative complications will be collected and categorized according to Glassman et al.

Cost data related to the hospital stay and care of any perioperative complications data will be recorded. These will include costs related to antibiotics, length of stay (including prolonged intensive care unit stay), and perioperative transfusion requirements. To approximate the costs related to transfusion, the investigators will include costs of acquisition, storage, and administration. Similar costs related to any other blood product administration will be collected and assigned as needed. The investigators anticipate that patient reported quality of life scores will be similar between groups. As this may not be the case, the investigators will collect quality adjusted life year (QALY) data through the ACEND survey. These data will be collected at the preoperative visit and at the 6, 12, and 24 month followup points.
A vaccine for treatment of foot-and-mouth disease of swine is provided. This vaccine is an antigenized antibody vaccine created from the grafting of peptide epitopes derived from FMDV into swine antibody CDR loops. FMDV peptide epitopes are cloned by PCR from VP1 gene of FMDV. The overlapping PCR method is used to insert the FMDV peptide epitopes into the CDR regions of swine immnuoglobulin heavy and light chains genes. The resulting antigenized antibody genes were cloned into mammalian expression vector. The plasmids are transfected into CHO or myeloma cells. The stable transfectant cell line was selected for high yield of the desired protein vaccine.
Reconstitute the vials with 0.9% Sodium Chloride Injection without preservatives. Add 5 mL to the 200 mg vial or 25 mL to the 1 g vial. These dilutions each yield a gemcitabine for injection concentration of 38 mg/mL. Complete withdrawal of the vial contents will provide 200 mg or 1 g of gemcitabine for injection. Prior to administration the appropriate amount of drug must be diluted with 0.9% Sodium Chloride Injection. Final concentrations may be as low as 0.1 mg/mL.

Reconstituted gemcitabine for injection is a clear, colorless to light straw-colored solution. Inspect visually prior to administration and discard for particulate matter or discoloration. Gemcitabine for injection solutions are stable for 24 hours at controlled room temperature of 20° to 25°C (68° to 77°F). Do not refrigerate as crystallization can occur. 

No incompatibilities have been observed with infusion bottles or polyvinyl chloride bags and administration sets.
Participants with eczema/dermatitis receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient antipruritic efficacy and there is no safety concern.