anthonyyazdaniml/gliner-biomed-curated-corpus huggingface dataset:
Pregnancy Category B: In a study in which rats were dosed from day 14 (females) or day 60 (males) prior to mating through the period of organogenesis, a slightly increased incidence of skeletal variations was observed at doses of 8 mg/kg/day (3 times the Maximum Recommended Human Dose [MRHD] on a mg/m2 basis) and 16 mg/kg/day. In a study in which pregnant rats were dosed from the beginning of organogenesis through day 21 post-partum, pup weights were decreased at 8 and 16 mg/kg/day, but no adverse effects on other postnatal developmental parameters were seen. The doses causing the above effects in rats produced slight maternal toxicity. No major malformations were caused in rats given up to 16 mg/kg/day. No drug related teratogenic effects were observed in rabbits given up to 40 mg/kg/day (32 times the MRHD on a mg/m2 basis) during the period of organogenesis. 

There are no adequate and well-controlled studies of RAZADYNE® in pregnant women. RAZADYNE® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Abruption has been estimated to occur in 6.5 pregnancies per 1000 births, with an associated perinatal mortality rate of 119 per 1000 in the United States. A Cochrane database study revealed that there is no evidence from trials to show the best way to help pregnant women and their fetuses when there is a placental abruption. The baby may need to be delivered immediately, by cesarean section if alive, and often vaginally if the baby has died. Treatments include pain relief, blood transfusion, and monitoring. Bleeding during pregnancy is characterized by activation of the fibrinolytic system. Tranexamic acid is a potent pharmaceutical agent that suppresses fibrinolysis and thus can be used for managing hemorrhage in pregnancy. The FDA's pregnancy category for tranexamic acid is category B.
Effects on Electrocardiogram

Thorough QT studies have been conducted for elvitegravir and cobicistat. The effect of the other two components, tenofovir and emtricitabine, or the combination regimen STRIBILD on the QT interval is not known.

Elvitegravir: In a thorough QT/QTc study in 126 healthy subjects, elvitegravir (coadministered with 100 mg ritonavir) 125 mg and 250 mg (0.83 and 1.67 times the dose in STRIBILD) did not affect the QT/QTc interval and did not prolong the PR interval. 

Cobicistat: In a thorough QT/QTc study in 48 healthy subjects, a single dose of cobicistat 250 mg and 400 mg (1.67 and 2.67 times the dose in STRIBILD) did not affect the QT/QTc interval. Prolongation of the PR interval was noted in subjects receiving cobicistat. The maximum mean (95% upper confidence bound) difference in PR from placebo after baseline-correction was 9.5 (12.1) msec for the 250 mg cobicistat dose and 20.2 (22.8) for the 400 mg cobicistat dose. Because the 150 mg cobicistat dose used in the STRIBILD fixed-dose combination tablet is lower than the lowest dose studied in the thorough QT study, it is unlikely that treatment with STRIBILD will result in clinically relevant PR prolongation. 

Effects on Serum Creatinine

The effect of cobicistat on serum creatinine was investigated in a Phase 1 study in subjects with an eGFR of at least 80 mL per minute (N=18) and with an eGFR of 50 to 79 mL per minute (N=12). A statistically significant change of eGFRCG from baseline was observed after 7 days of treatment with cobicistat 150 mg among subjects with an eGFR of at least 80 mL per minute (-9.9 ± 13.1 mL/min) and subjects with an eGFR of 50 to 79 mL per minute (-11.9 ± 7.0 mL per minute). These decreases in eGFRCG were reversible after cobicistat was discontinued. The actual glomerular filtration rate, as determined by the clearance of probe drug iohexol, was not altered from baseline following treatment of cobicistat among subjects with an eGFR of at least 50 mL per minute, indicating cobicistat inhibits tubular secretion of creatinine, reflected as a reduction in eGFRCG, without affecting the actual glomerular filtration rate.
The present invention discloses a patch for transdermal drug delivery and a method of controlling drug release of the same by near-IR. The patch for transdermal drug delivery comprises a substrate, a carrier and drugs. The drugs are encapsulated in the carrier, and the carrier having the drugs is disposed on a surface of the substrate. The carrier is formed of biodegradable polymers, and nano-particles with a photothermal conversion effect are loaded in the carrier. When the carrier is inserted into the skin and the nano-particles in the carrier absorb the near-IR, the near-IR is converted into heat by the nano-particles for melting the carrier and thus releasing the drugs encapsulated in the carrier into the skin. Accordingly, the velocity of releasing the drugs encapsulated in the carrier can be controlled accurately by the near-IR.
Compounds that specifically inhibit or reduce leukocyte adhesion or function are useful to enhance vascular healing and lessen restenosis of blood vessels after revascularization, via angioplasty or bypass surgery, of diseased coronary, peripheral and cerebral arteries, and lessen stenosis or restenosis of surgically-placed bypass grafts and transplanted organs. Examples of these compounds are those which block cell surface integrins or their ligands, for example, the leukocyte integrin Mac-1 (CD11b/CD18, αMβ2). As demonstrated by the examples, both superficial and deep injury was significantly reduced with treatment using an antibody to Mac-1 compared to both saline controls and IgG controls. After balloon angioplasty (superficial injury) neointimal area was reduced nearly 70 %. The ratio of intimal:medial area, which is customarily used in balloon-injured experimental arteries to normalize for small normal variations in arterial size from one animal to another, was reduced over 75 %. After endovascular stent implantation (deep injury) neointimal area was reduced nearly 40 %. Extrapolated to humans, this reduction in the intimal thickening would reduce restenosis from occuring in approximately 30 % of patients to less than 10 % of patients.
Following a screening period, participants will receive DAC HYP over a 24-week treatment period (6 monthly injections) and then enter a 20-week washout period for assessment of immunogenicity, PK, pharmacodynamics, safety, and tolerability. The 20-week washout is necessary to ensure measurement of anti-DAC HYP binding antibodies (ADAbs) and neutralizing antibodies (NAbs) in the absence of drug interference. After washout, the participants may resume monthly treatment with DAC HYP 150 mg for an additional 3 years. All participants will be followed for 6 months after their last dose for safety monitoring. Additionally, two sub-studies will be performed: (1) an intensive serial PK sampling performed over the first and last dosing interval following DAC HYP doses administered at week 0 and at week 20, and (2) a therapeutic protein-drug interaction (TP-DI) sub-study, during which a probe drug cocktail will be administered at weeks 43 and 53 followed by serial probe-drug PK sampling up to 96 hours after probe-drug administration. A maximum of 20 participants will be enrolled in the TP-DI sub-study.
A novel aluminum magnesium hydroxy fatty acid compound is disclosed having a general formula, AlxMgy(OH)3x+2y-zRz.nH2O, wherein R is at least one aliphatic monocarboxylic acid group having the formula RCOO- and comprising from 12 to 22 carbon atoms, and wherein x=2, 2</=y</=10, z=2, and n is an integer greater than zero. The compound is prepared by a process including placing water and a salt which is one of an alkali metal salt or an ammonium salt of at least one aliphatic monocarboxylic acid having from 12 to 22 carbon atoms in a reactor fitted with heating and stirring means. The salt is dissolved by intensive stirring and by heating to a temperature ranging from 20 DEG  to 90 DEG  C. to provide a salt solution. The pH of the salt solution in the reactor is maintained at a pH of at least 8 to provide an alkaline solution. A solution comprised of water, an aluminum salt, and a magnesium salt is added to the reactor under constant stirring to cause reaction and precipitation of a precipitate comprised of the novel aluminum magnesium hydroxy fatty acid compound. The precipitate is separated and washed with substantially demineralized water until substantially no anions of the aluminum salt and the magnesium salt are detectable. A lipogel with improved thermal stability is formed using the novel compound and organic lipophilic compounds which are liquid at room temperature, and is useful in cosmetic or pharmaceutical preparations.
Gaucher disease, the most prevalent lysosomal storage disease, is caused by homozygous mutations at the GBA gene, which is responsible for encoding the enzyme glucocerebrosidase. Neuronopathic Gaucher disease is associated with microgliosis, astrogliosis, and neurodegeneration. However, the role that microglia, astrocytes, and neurons play in the disease remains to be determined. In the current study, we developed inducible, cell-type-specific Gba-KO mice to better understand the individual impacts of Gba deficiencies on microglia and neurons. Gba was conditionally knocked out either exclusively in microglia or neurons or throughout the body. These mouse models were developed using a tamoxifen-inducible Cre system, with tamoxifen administration commencing at weaning. Microglia-specific Gba-KO mice showed no signs of disease. However, the neuron-specific Gba KO resulted in a shortened lifespan, severe weight loss, and ataxia. These mice also had significant neurodegeneration, microgliosis, and astrogliosis accompanied by the accumulation of glucosylceramide and glucosylsphingosine, recapitulating Gaucher disease-like symptoms. These surprising findings reveal that, unlike the neuron-specific Gba deficiency, microglia-specific Gba deficiency alone does not induce disease. The neuronal Gaucher disease mouse model, with a median survival of 16 weeks, may be useful for future studies of pathogenesis and the evaluation of therapies.
Men aged 15 years or older, who self-report a HIV-negative or unknown HIV status at enrolment and last tested for HIV three or more months are enrolled into the study. Enrolled men receive two HIV self-test kits from a trained community-based distributor (or peer-leader). Peer-leaders are selected from existing social networks and are trained in HIV self-testing procedures prior to distributing HIV self-test kits. The goal of the study is to assess if distribution of HIV self-test kits to men through trained local peer-leaders is feasible and acceptable in a fishing community context, and whether this approach can help to improve access to HIV testing services and, by implication, improve HIV testing uptake and subsequent linkage to appropriate HIV prevention, care and treatment services. Men are interviewed at baseline will be followed up at 1, 6 and 12 months post-baseline to determine HIV testing uptake, linkage to and retention in HIV care.
In recent years, scientific literature has focused on the search for new non-invasive diagnostic tools that can identify patients with endometriosis early and easily, thereby reducing diagnostic delay and enabling the immediate initiation of appropriate treatment. Among these, microRNA (miRNA) is emerging as a promising option. Despite recent progress in this field, a predictive biomarker of response to medical therapy or vice versa, resistance to progesterone in endometriosis, has not yet been identified, including among miRNAs. This study aims, therefore, to identify salivary miRNA signatures specific to endometriosis and differentially expressed between responder and non-responder patients to 2 mg dienogest medical therapy. 90 patients diagnosed with endometriosis attending the Obstetrics and Gynecology Clinic at the Santa Maria della Misericordia Hospital in Udine will be enrolled. The investigators will ask them for a salivary sample before starting the progestin therapy. After 4 months from the beginning, the response will be evaluated. The researchers will evaluate the differences between salivary miRNA of the responders vs non-responders.
Significant acute postoperative pain remains prevalent among patients who undergo truncal surgery and is associated with increased morbidity, prolonged patient recovery, and increased healthcare costs. The provision of high-quality postoperative analgesia is an important component of postoperative care, particularly within enhanced recovery programmes. Regional anaesthetic techniques have become increasingly prevalent within multimodal analgesic regimens and the widespread adoption of ultrasonography has facilitated the development of novel fascial plane blocks. The number of described fascial plane blocks has increased significantly over the past decade, leading to a burgeoning area of clinical investigation. Their applications are increasing, and truncal fascial plane blocks are increasingly recommended as part of procedure-specific guidelines. Some fascial plane blocks have been shown to be more efficacious than others, with favourable side-effect profiles compared with neuraxial analgesia, and are increasingly utilised in breast, thoracic, and other truncal surgery. However, use of these blocks is debated in regional anaesthesia circles because of limitations in our understanding of their mechanisms of action. This narrative review evaluates available evidence for the analgesic efficacy of the most commonly practised fascial plane blocks in breast, thoracic, and abdominal truncal surgery, in particular their efficacy compared with systemic analgesia, alternative blocks, and neuraxial techniques. We also highlight areas where investigations are ongoing and suggest priorities for original investigations.
Participant will receive caffeine citrate 20mg/kg IV within 2 hours of life and placebo (normal saline IV) at 12 hours of life. Both infusions will be of identical volumes and appearance, and will be administered over 30 minutes.
Additional (expansion of) participants will dose with 2000 mg daily oral PC14586 (INN: rezatapopt) with food for continued evaluation. Endometrial Cancer Cohort participants will have locally advanced or metastatic endometrial cancer harboring a TP53 Y220C mutation who meet all eligibility criteria and have measurable disease per RECIST 1.1.
Adverse Reactions in Clinical Trials of a bioequivalent form of doxycycline hyclate capsules: In clinical trials of adult patients with periodontal disease 213 patients received 20 mg BID over a 9 to 12 month period. The most frequent adverse reactions occurring in studies involving treatment with a bioequivalent form of doxycycline hyclate capsules or placebo are listed below:

Incidence (%) of Adverse Reactions in Clinical Trials of Doxycycline Hyclate Capsules, 20 mg (Bioequivalent to Doxycycline Hyclate Tablets, 20 mg) vs. Placebo

Note: Percentages are based on total number of study participants in each treatment group.

Adverse Reactions for Tetracyclines: The following adverse reactions have been observed in patients receiving tetracyclines:

Gastrointestinal: anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, and inflammatory lesions (with vaginal candidiasis) in the anogenital region. Hepatotoxicity has been reported rarely. Rare instances of esophagitis and esophageal ulcerations have been reported in patients receiving the capsule forms of the drugs in the tetracycline class. Most of these patients took medications immediately before going to bed. (See DOSAGE AND ADMINISTRATION Section).

Skin: maculopapular and erythematous rashes. Exfoliative dermatitis has been reported but is uncommon. Photosensitivity is discussed above. (See WARNINGS Section).

Renal toxicity: Rise in BUN has been reported and is apparently dose related. (See WARNINGS Section).

Hypersensitivity reactions: urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, serum sickness, pericarditis, and exacerbation of systemic lupus erythematosus.

Blood: Hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia have been reported.
Aneuploidy is common in eukaryotes, often leading to decreased fitness. However, evidence from fungi and human tumur cells suggests that specific aneuploidies can be beneficial under stressful conditions and facilitate adaptation. In a previous evolutionary experiment with yeast, populations evolving under heat stress became aneuploid, only to later revert to euploidy after beneficial mutations accumulated. It was therefore suggested that aneuploidy is a "stepping stone" on the path to adaptation. Here, we test this hypothesis. We use Bayesian inference to fit an evolutionary model with both aneuploidy and mutation to the experimental results. We then predict the genotype frequency dynamics during the experiment, demonstrating that most of the evolved euploid population likely did not descend from aneuploid cells, but rather from the euploid wild-type population. Our model shows how the beneficial mutation supply-the product of population size and beneficial mutation rate-determines the evolutionary dynamics: with low supply, much of the evolved population descends from aneuploid cells; but with high supply, beneficial mutations are generated fast enough to outcompete aneuploidy due to its inherent fitness cost. Our results suggest that despite its potential fitness benefits under stress, aneuploidy can be an evolutionary "diversion" rather than a "stepping stone": it can delay, rather than facilitate, the adaptation of the population, and cells that become aneuploid may leave less descendants compared to cells that remain diploid.
A system and method of delivering personalized health interventions to a client over a computer network are provided. A user interface is provided to a client over the computer network, and health issue information is received back from the client. Personalized health interventions directed to the client are determined based on the received information. Selected audio and/or visual health interventions are delivered to the client. The selected interventions are presented to the client in the form of a daily health intervention schedule listing interventions by time. The schedule includes links to several health interventions which can be accessed through a client computer screens. The schedule may be linked with local scheduling applications.
This Competing Renewal project continues the research and development of a parent-focused intervention, Parent Guide to SSGRIN, which parallels an established child-focused intervention \[Social Skills GRoup INtervention (S.S. GRIN); for children ages 8-12 years\], in order to teach and reinforce the same social skills and concepts within the home environment. A primary goal of this Competing Renewal is to conduct a rigorous, large-scale, longitudinal research project that is adequately powered to address questions of relative impact, longer-term treatment benefits, and differential treatment effects of the Parent Guide training on children's social skill development across settings and populations. Though schools often struggle with how to increase parent involvement in school-based programs, school officials report that it is infeasible for them to conduct the full series of in-person parent training groups as the Parent Guide's current curriculum demands; therefore, a second goal of this Competing Renewal is to test a Home-study version of the Parent Guide to bridge training into the home environment. The Home-study version of the Parent Guide will be included as a separate treatment condition within the effectiveness trial. This clinical trial will provide S.S.GRIN treatment for 240 children ages 8-12 and vary the level of parent intervention to determine the effectiveness of the two variations of Parent Guide to S.S.GRIN. Parents will be randomly assigned to one of four conditions: (1) Parent Guide treatment; (2) Parent Guide-Home Study treatment; (3) parent attention control; or (4) no treatment. Pre-treatment, post-treatment, 6-month post-treatment, and 12 month post-treatment data will be collected assessing children's social skill development from children, parents, and teachers. Based on past clinical experience, the probability of adverse psychological and behavioral effects from behavioral intervention is very low; however, to ensure participants' safety, a data and safety monitoring plan will be in place.
This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.
Aims \& Objectives: To conduct a randomized, triple-blind, placebo-controlled study by standardizing dose of local anesthetic, to compare the effectiveness of intraperitoneal against intraincisional use of ropivacaine 0.2% for post-laparoscopic cholecystectomy pain relief.

Materials \& Methods: American Society of Anesthesiologists (ASA) physical status I or II patients underwent elective 4 port laparoscopic cholecystectomy by a single surgeon. Anesthetic and surgical techniques were standardized. Patients were randomized using envelope method into 3 groups according to location of drug use. Triple blinding was ensured and envelopes were opened only at the completion of study. All patients received \~23 ml of solution, of which 20 ml was given intraperitoneally \[1 ml/cm; 16 ml along right hemi-dome, approximately equal to length of right hemi-dome of diaphragm in an average adult and 4 ml in gall bladder fossa) and \~3 ml intraincisionally (1 ml/cm of length of incision). Controls (n=86) received \~23 ml normal saline (20 ml intraperitoneally and 1 ml/cm intraincisionally) while the intraperitoneal group (n=100) received 20 ml of intraperitoneal instillation of injection ropivacaine 0.2% and 1 ml/cm of normal saline intraincisionally at the end of procedure. Intraincisional group (n=108) received 20 ml normal saline intraperitoneally and 1 ml/cm of injection ropivacaine 0.2% infiltration at incisional site at the end of procedure. All patients received injection diclofenac sodium 75mg/1ml (aqueous) intravenously 12 hourly postoperatively. 5 different pain scales were used for assessment of overall pain. Pain scores were assessed at 5 points of time, that is, at 0.5, 4, 8, 12 and 24 hours postoperatively. Shoulder pain and extra dose of analgesic required (rescue analgesia) were also recorded.
Preparations for the care of the mouth and teeth, e.g. tooth pastes or powders and mouth washes, comprise a foam-forming substance and a vitamin concentrate of cod liver oil together with the usual ingredients of such preparations.  The vitamin concentrate is a vitamin containing fraction of cod liver oil redissolved in cod liver oil or in a neutral, preferably vegetable, oil and containing, e.g. 1,000,000 U.S.P. units, of vitamin A and 5,000 U.S.P. units of vitamin D per gram.  The foam-forming substance may be soap and/or a sulphonated aliphatic alcohol, e.g. sulphonated derivatives of tridecyl, myristic, pentadecyl, cetyl, undecyl and stearyl alcohols. According to examples (a) a tooth paste consists of 2 per cent vitamin concentrate, soap, glycerol, kaolin, calcium carbonate, magnesium carbonate or mixtures thereof and flavouring agents with or without a sulphonated aliphatic alcohol, e.g. sulphonated lauryl or triecyl alcohol, and in which the glycerol may be replaced by glucose syrup and the kaolin by colloidal silicic acid, talc or phosphates; (b) a mouth wash consists of 20 per cent vitamin concentrate, soap, ethyl alcohol and flavouring substances with or without the further addition of a sulphonated alcohol, glycerol and emulsifying agents such as triethanolamine, polymerized ethylene oxide, triethanolamine oleate, ammonium linoleate and ammonium oleate.  Other vitamins, particularly vitamin C, may be incorporated in the preparations. Specification 457,385 is referred to.