anthonyyazdaniml/gliner-biomed-curated-corpus huggingface dataset:
The purpose of this study is to evaluate the safety of and the clinical response to a human monoclonal anti-interleukin-12 antibody (J695) administered to patients with Crohn's disease. Crohn's disease, an incurable, chronic, relapsing inflammation of the small and large intestine, affects approximately 500,000 people in the United States. The disease is characterized by full-thickness involvement of the gut wall leading to episodes of abdominal pain, diarrhea, hematochezia, weight loss and complications such as bowel obstruction, fistula formation and extraintestinal manifestations. The rationale for this study is based on two compelling observations. First, despite the standard therapeutic use of steroids, aminosalicylates, antibiotics, antimetabolite immunosuppressants (6-MP, methotrexate), and early agents of the emerging biologics class of drugs (anti-TNF alpha antibodies, e.g.), the treatment of Crohn's disease is still troubled by loss of effectiveness of standard therapy over time, outright nonresponsiveness, and serious medication side effects. For these reasons newer agents for the treatment of Crohn's disease need to be developed and tested. Second, studies in both animals and humans support a central role for IL-12 in the gut inflammatory response in Crohn's disease. Administration of anti-IL-12 antibodies in animal models has prevented inducible or ameliorated established colitis. For these reasons IL-12 is an appropriate therapeutic target for the treatment of Crohn's disease.

This study proposes to measure the toxicity and clinical effect of two doses of anti-IL-12 (J695) administered subcutaneously to patients with moderately active Crohn's disease. The primary outcome measure is the rate and severity of adverse events. Secondary outcome measures include J695 pharmacodynamics, incidence of anti-J695 antibodies, and clinical response. A separate substudy at the NIH will measure gut lymphocyte apoptosis and gut and peripheral blood cytokine responses to study drug as well as endoscopic and histologic response to treatment. Our short-term goal is to assure good tolerance of anti-IL-12 treatment regimens in Crohn's disease patients and observe a beneficial clinical response. The long-term goal of this study is to establish anti-IL-12 as an effective alternative with a low risk profile in the therapeutic armamentarium for Crohn's disease.
The invention relates to a fluvastatin sodium composition. Specifically, the invention relates to a novel and stable solid drug formula which is particularly suitable for treating hypercholesterolemia and hyperlipidemia. Particularly, the invention relates to a novel and stable solid drug formula which contains an active material HMG-CoA reductase inhibitor, namely fluvastatin or a pharmaceutically active salt thereof. The solid pharmaceutical composition disclosed by the invention contains fluvastatin sodium, lipid substances, saccharides and optional pharmaceutical excipients. The solid pharmaceutical composition disclosed by the invention has excellent properties, e.g. chemical properties.
NEW MATERIAL:A compound of the formula (R is H, acetyl). EXAMPLE:23-0-Acetyl-thyrsiferol. USE:Antitumor agent. PREPARATION:For example, MAGIRESOZO (a red alga: Leurencia obtsusa) is extracted with a hydrophilic organic solvent such as methanol, the resultant extract is dissolved in a hydrophobic organic solvent such as ether, and the solution is washed with water, then preferably washed with aqueous alkali and aqueous acid. Then, the product is adsorbed to an activated adsorbent such as silica gel, eluted with benzene and the resultant eluate is subjected to partition chromatography to effect separation and purification to give a compound of formula I. The product is acetylated, preferably in the presence of a base such as triethylamine to give another compound of the formula, where R is acetyl.
Patients will be assigned escalated dose according to BOIN design. The starting dose is 5 mg orally once a day for 7 consecutive days followed by 14 days of rest.
Activity Based Rehabilitation is comprised of intensive, progressive, functional task practice. The protocol consists of repetitive activities of gross upper limb movement, isolated finger movements, bimanual task performance, simple and complex pinch, and grip performance. Several activities with various difficulty levels are designated for each category, and the participant will perform 1-2 activities within each category in each rehabilitation session. Rehabilitation sessions will be three times per week, 90 minutes per session for six weeks (total of 18 sessions).
This is an open-label, non-randomized, two-stage, FIH Phase 1 study, utilizing an accelerated dose escalation followed by a traditional 3 + 3 dose escalation algorithm to identify the MTD and/or RDE and RP2D of LVGN6051 as a single agent (monotherapy) and in combination with pembrolizumab (MK-3475). The first stage of the study is the dose escalation phase (i.e., Phase 1a). The second stage of the study is the dose expansion phase (i.e., Phase 1b). During the study, dose interruption(s) and/or delay(s) may be implemented based on toxicity. Dose modifications are not permitted. Intra-patient dose escalations will be allowed for the early dose cohorts (single-patient dose groups) in Phase 1a Part 1. Patients will be considered evaluable for safety and tolerability if they receive at least one dose of LVGN6051 or pembrolizumab (MK-3475) at the specified cohort dose. Patients in all parts of the trial will remain on therapy until confirmed disease progression or for 2 years, whichever occurs first. However, patients who are clinically unstable will discontinue following the initial assessment of disease progression.
The main objectives of the proposed 2 phase-protocol in aged Canadian veterans (n=60) are to evaluate the impact of 2000 IU/day of vitamin D3 supplementation (tablets or liquid form) on correcting low vitamin D status and the associated impact on biochemistry, bone health markers and markers of inflammation in a Fall period (Before and After, 8 weeks) and, 2) evaluate which food-based supplementation will maintain vitamin D3 status thereafter from winter through spring by measuring serum 25(OH)D concentration following intake of vitamin D delivered (with liquid form vitamin D3) using foods as the vehicle providing an additional 1000 IU/day or 500 IU/day compared to regular meals offered at Ste-Anne's Hospital (SAH) (Randomized Controlled Trial, 3 groups, 24 weeks). Anthropometry (weight, height, BMI, mid-arm and mid-calf circumferences), grip strength, biochemical markers of bone health (25(OH)D, PTH, calcium, ionized calcium and phosphate), assessments of cognitive and functional status (Mini-Mental State Evaluation, Frail Elderly Functional Assessment, Physiotherapy Functional Mobility Profile and Pain Assessment Checklist) as well as volumetric bone mineral density using peripheral quantitative computed tomography (pQCT) will be gathered.

The long-term goal of the research program is to use novel food-delivery systems and approaches to enhancing vitamin D intake that meets the needs of this population. For years, medications have been delivered through foods but few studies have applied this to natural health products such as vitamin D. In chronic care, the number of prescription pills is high often 13 or more not accounting for multiple administrations over a day. Further documentation of health related indicators such as capacity to perform daily activities and chronic pain intensity would relate to quality of life and improve our understanding of vitamin D in more than bone health related issues. The reality of long-term care facilities (financial, human and material resources) needs to be addressed for the newly developed delivery modes to meet the needs of these residents and the projected increase in care required for our aging Canadian population. Large scale interventions will need to take place to give more insight on efficacy and efficiency of this new food delivery approach.
Participants will engage in 18 weight loss intervention group sessions over 6 months. Sessions will occur weekly for the first 3 months, and biweekly for the latter 3 months. Participants will receive a behavioral weight loss curriculum, calorie and physical activity recommendations. This arm, uniquely, will receive a culturally based physical activity component.
Although the post- anesthesia care unit can be noisy, the effect of noise on patients recovering from anesthesia is unknown. Indeed, many studies are achieved in reanimation or ICU. That's why this prospective study is about patients' satisfaction after their stay in the post-anesthesia care unit. In a first part, noise is just measured with a sound level meter and patients are asked about their experience. Before the second part, during few days, nurses will be informed about noise consequences on heath. With some precaution, a decrease of the sound level in a room (ex: decrease scope alarms, speaking quietly, not slamming the drawer, noise warning device...) will be expected. The main objective is to determine the patient's satisfaction in the post-anesthesia care unit before and after installation of a noise warning device.
The survey included 69 patients, 42 patients had a diagnosis of Bladder Pain Syndrome/Interstitial Cystitis while 27 of them had chronic non-neoplastic pain. The comparison of the total values of the PHQ-9 between the two groups, 1 versus 2, in relation to final score of PHQ-9, the average PHQ-9 score was 10.3 in group 1, therefore a value greater than 9, considered as major depression (score between 10 and 14); the average score of PHQ-9 was 6.9 in group 2, as in sub-threshold depression (between 5-9). Correlation between PHQ-9 and BPI was also evaluated, the relation was significant only in interstitial cystitis with regard to the following spheres: daily life, work activity, pleasure of life, mood, sleep quality, pain intensity, and urinary symptoms. Based on these data, when PHQ-9 score increases, and depressive symptoms worsen, there is interference with daily life and work activity, pleasure of living, mood, quality of sleep, perception of intensity of pain and urinary symptoms. Patients who had onset of psychiatric symptoms following diagnosis (both interstitial cystitis and other painful syndromes) had an average PHQ-9 score of 11.7 compared to the score of 8.3 of patients without onset of psychiatric symptoms after diagnosis (p = 0.0464), so it may be that depressive symptoms starting after the diagnosis of pain syndrome are more severe. Women who undergo psychiatric-psychological consultation and therapy have an average O'Leary score 20.4 compared to 25.8 in those who are not under psychiatric consultation (p = 0.0418). This emphasizes how psychosocial support can improve perception of pain and urinary symptoms.
Pelvic organ prolapse (POP) is a common disorder among women that negatively affects women's quality of life. Early growth response 2 (EGR2) is a transcription factor that regulates cell growth. The present study aimed to explore the role of EGR2 in POP progression and provided a new target for the treatment and prevention of POP. Firstly, we extracted primary vaginal anterior wall fibroblasts from POP tissues and non-POP tissues and then constructed an EGR2-silencing lentivirus for further study. Immunoblotting, qPCR, TUNEL assay, CCK-8 assay, dual luciferase assay, and ELISA assay were carried out. EGR2 expression was much higher in POP tissues than in control tissues, and EGR2 expression positively correlated with cytokine signaling 3 (SOCS3) expression. Knockdown of EGR2 increased cell proliferation, upregulated PCNA expression, and reduced apoptosis in POP fibroblasts. Moreover, we found that the knockdown of EGR2 increased COL1A1, COL3A1, and Elastin expression and decreased MMP2 and MMP9 activities, and knockdown of EGR2 increased TGF-β/Smad pathway activity in POP fibroblasts. Interestingly, the results of dual luciferase assay demonstrated that EGR2 was able to increase SOCS3 transcriptional activity. EGR2 knockdown alleviated the apoptosis of POP fibroblasts by reducing SOCS3 expression and improving the proliferation and collagen synthesis of POP fibroblasts. Overall, our study illustrated that EGR2 was highly expressed in POP tissues, and knockdown of EGR2 alleviated apoptosis and reduced matrix degradation in POP fibroblasts. This study might provide a new insight into the pathogenesis of POP.
* Use the lowest naproxen dose for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5.1)].
  * Carefully consider the potential benefits and risks of VIMOVO and other treatment options before deciding to use VIMOVO.
  * VIMOVO does not allow for administration of a lower daily dose of esomeprazole magnesium. If a total daily dose of less than 40 mg esomeprazole is more appropriate, a different treatment should be considered.
  * Swallow VIMOVO tablets whole with liquid. Do not split, chew, crush or dissolve the tablet. Take VIMOVO at least 30 minutes before meals.
  * Patients should be instructed that if a dose is missed, it should be taken as soon as possible. However, if the next scheduled dose is due, the patient should not take the missed dose, and should be instructed to take the next dose on time. Patients should be instructed not to take 2 doses at one time to make up for a missed dose.
  * Antacids may be used while taking VIMOVO.
Ezetimibe and simvastatin

Plasma cholesterol is derived from intestinal absorption and endogenous synthesis. Ezetimibe and simvastatin tablets contain ezetimibe and simvastatin, two lipid-lowering compounds with complementary mechanisms of action. Ezetimibe and simvastatin reduces elevated total-C, LDL-C, Apo B, TG, and non-HDL-C, and increases HDL-C through dual inhibition of cholesterol absorption and synthesis.

Ezetimibe

Ezetimibe reduces blood cholesterol by inhibiting the absorption of cholesterol by the small intestine. The molecular target of ezetimibe has been shown to be the sterol transporter, Niemann-Pick C1-Like 1 (NPC1L1), which is involved in the intestinal uptake of cholesterol and phytosterols. In a 2-week clinical study in 18 hypercholesterolemic patients, ezetimibe inhibited intestinal cholesterol absorption by 54%, compared with placebo. Ezetimibe had no clinically meaningful effect on the plasma concentrations of the fat-soluble vitamins A, D, and E and did not impair adrenocortical steroid hormone production.

Ezetimibe localizes at the brush border of the small intestine and inhibits the absorption of cholesterol, leading to a decrease in the delivery of intestinal cholesterol to the liver. This causes a reduction of hepatic cholesterol stores and an increase in clearance of cholesterol from the blood; this distinct mechanism is complementary to that of statins [see Clinical Studies (14)]. 

Simvastatin

Simvastatin is a prodrug and is hydrolyzed to its active β-hydroxyacid form, simvastatin acid, after administration. Simvastatin is a specific inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the enzyme that catalyzes the conversion of HMG-CoA to mevalonate, an early and rate limiting step in the biosynthetic pathway for cholesterol. In addition, simvastatin reduces very-low-density lipoproteins (VLDL) and TG and increases HDL-C.
An ultrasound transducer is coupled to a transmitter having a source of ultrasound signal. A receiving ultrasound transducer is coupled to a preamplifier and mixer. The mixer is further coupled to a demodulator and filter which in turn is coupled to an amplifier and a comparator. The comparator output is coupled to a controller which performs edge detection of the comparator output signal. The transmitter produces ultrasound energy which is reflected from an object to the receiving transducer. The shift in frequency between the transmitted ultrasound energy and the reflected ultrasound energy is used to determine the speed of the object by employing doppler effect. Frequency detection is enhanced by mixing the transmitted and reflected ultrasound signals to provide a beat frequency signal.
Pregnancy Category C:

There are no studies in pregnant women. Alendronate sodium should be used during pregnancy only if the potential benefit justifies the potential risk to the mother and fetus.

Bisphosphonates are incorporated into the bone matrix, from which they are gradually released over a period of years. The amount of bisphosphonate incorporated into adult bone, and hence, the amount available for release back into the systemic circulation, is directly related to the dose and duration of bisphosphonate use. There are no data on fetal risk in humans. However, there is a theoretical risk of fetal harm, predominantly skeletal, if a woman becomes pregnant after completing a course of bisphosphonate therapy. The impact of variables such as time between cessation of bisphosphonate therapy to conception, the particular bisphosphonate used, and the route of administration (intravenous versus oral) on the risk has not been studied.

Reproduction studies in rats showed decreased postimplantation survival and decreased body weight gain in normal pups at doses less than half of the recommended clinical dose. Sites of incomplete fetal ossification were statistically significantly increased in rats beginning at approximately 3 times the clinical dose in vertebral (cervical, thoracic, and lumbar), skull, and sternebral bones. No similar fetal effects were seen when pregnant rabbits were treated with doses approximately 10 times the clinical dose.

Both total and ionized calcium decreased in pregnant rats at approximately 4 times the clinical dose resulting in delays and failures of delivery. Protracted parturition due to maternal hypocalcemia occurred in rats at doses as low as one tenth the clinical dose when rats were treated from before mating through gestation. Maternotoxicity (late pregnancy deaths) also occurred in the female rats treated at approximately 4 times the clinical dose for varying periods of time ranging from treatment only during pre-mating to treatment only during early, middle, or late gestation; these deaths were lessened but not eliminated by cessation of treatment. Calcium supplementation either in the drinking water or by minipump could not ameliorate the hypocalcemia or prevent maternal and neonatal deaths due to delays in delivery; intravenous calcium supplementation prevented maternal, but not fetal deaths.

Exposure multiples based on surface area, mg/m2, were calculated using a 40-mg human daily dose. Animal dose ranged between 1 and 15 mg/kg/day in rats and up to 40 mg/kg/day in rabbits.
Mild aqueous detergent, e.g. shampoo, compositions are disclosed based on a mixture comprising anionic surfactant and amphoteric surfactant, such as betaines, present in the composition at a level of from about 0.75 to 1.25 parts by weight per part by weight of anionic surfactant. The compositions also contain one or a mixture of therapeutic agents such as climbazole or a mixture of climbazole and one or more co-therapeutics such as salicylic acid. The combination of mild surfactant system and therapeutic agent serve to prevent or treat mild skin disorders such as scalp itch and scalp irritation when applied to the scalp as a shampoo. Shampoo compositions also preferably contain one or more conditioning agents and suitable suspending agents. The invention also provides a method for treating dry skin comprising applying certain of the therapeutic agents to dry skin to promote the natural secretion of agents to dry skin to promote the natural secretion of sebum.
Two 12-week, double-blind, placebo-controlled studies enrolled 178 (RADIANCE trial) and 88 (PROVED trial) adult patients with NYHA Class II or III heart failure previously treated with oral digoxin, a diuretic, and an ACE inhibitor (RADIANCE only) and randomized them to placebo or treatment with digoxin tablets. Both trials demonstrated better preservation of exercise capacity in patients randomized to digoxin tablets. Continued treatment with digoxin reduced the risk of developing worsening heart failure, as evidenced by heart failure-related hospitalizations and emergency care and the need for concomitant heart failure therapy.

DIG Trial of Digoxin in Patients with Heart Failure   
The Digitalis Investigation Group (DIG) main trial was a 37-week, multicenter, randomized, double-blind mortality study comparing digoxin to placebo in 6800 adult patients with heart failure and left ventricular ejection fraction less than or equal to 0.45. At randomization, 67% were NYHA class I or II, 71% had heart failure of ischemic etiology, 44% had been receiving digoxin, and most were receiving a concomitant ACE inhibitor (94%) and diuretics (82%). As in the smaller trials described above, patients who had been receiving open-label digoxin were withdrawn from this treatment before randomization. Randomization to digoxin was again associated with a significant reduction in the incidence of hospitalization, whether scored as number of hospitalizations for heart failure (relative risk 75%), risk of having at least one such hospitalization during the trial (RR 72%), or number of hospitalizations for any cause (RR 94%). On the other hand, randomization to digoxin had no apparent effect on mortality (RR 99%, with confidence limits of 91 to 107%).
The treatment group will receive one 30-minute session of orthopedic manual physical therapy targeting the knee joint and soft tissues with complementary exercises targeted at their impairment. The manual therapy and exercises are tailored to the individual based on their limitations and restrictions.
A preparation method and application of an external medicine for treating cardiovascular and cerebrovascular diseases and rheumatism fills the blank of the prior art. It is characterized by that 17 Chinese herbal medicines of asarum, etc. are soaked in sorghum liquor according to a specific dosage, then the soaked Chinese herbal medicines are applied to one of three groups of acupoints, and the obtained mixture is kneaded for 10-15 seconds. Can be used for treating coronary heart disease, hyperlipemia, hypertension, early cerebral thrombosis, rheumatic heart disease, cerebral thrombosis sequelae (apoplexy), and cerebral hemorrhage with effective rate of 100% and cure rate of 41.8%. The medicinal liquid can also be applied directly to affected part for treating rheumatalgia, scapulohumeral periarthritis, arthritis, lumbago, innominate swelling and pain, and numbness of limbs. The cure rate reaches 96.8 percent, and the effective rate reaches 100 percent.
The present invention relates to a method of generating a mammalian stem cell carrying a transgene, the method comprising inserting a transgene into the genome of the mammalian stem cell by means of zinc finger nuclease (ZFN) mediated integration. The invention also relates to a mammalian cell obtained by this method as well as to a pharmaceutical composition containing such a mammalian stem cell. The invention further relates to a method of treating a patient having a disease, the method comprising administering the patient a mammalian stem cell of the invention. In illustrative embodiments the disease is a disease associated with a deficiency of a gene or deficiency of the expression of the gene such as a gene selected from the group consisting of a gene encoding a blood coagulation factor and a gene encoding a protein hormone secreted by an endocrine gland. The blood coagulation factor may be selected from the group consisting of factor VII, factor VIII and factor IX and the disease may be any form of hemophilia, i.e. hemophilia A, hemophilia B or hemophilia C.