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

DUVYZAT is indicated for the treatment of DMD, which is a disease of predominantly young male patients. Therefore, there are no adequate data available to assess the use of DUVYZAT in pregnant women. In animal studies, oral administration of givinostat during organogenesis resulted in decreased fetal body weight and increased structural variations; oral administration during pregnancy and lactation resulted in increased embryofetal and offspring mortality and neurobehavioral changes in the offspring. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Data

Animal Data

Oral administration of givinostat (0, 40, 80, or 160 mg/kg/day) to pregnant rats throughout organogenesis resulted in reduced fetal body weight at the highest dose tested and increases in the incidence of skeletal and visceral variations at the mid and high doses. The no-effect dose (40 mg/kg/day) for adverse effects on embryofetal development was associated with maternal plasma exposures (AUC) lower than that in humans at the maximum recommended human dose (MRHD) of 53.2 mg twice daily.

Oral administration of givinostat (0, 40, 80, or 160 mg/kg/day) to pregnant rabbits throughout organogenesis resulted in maternal death at the highest dose tested, resulting in too few fetuses to evaluate. No adverse effects on embryofetal development were observed at the low and mid doses. Plasma exposures (AUC) at the higher no-effect dose (80 mg/kg) for adverse effects on embryofetal development were approximately 4 times that in humans at the MRHD.

Oral administration of givinostat (0, 40, 80, or 160 mg/kg/day) to rats throughout pregnancy and lactation resulted in increases in embryofetal mortality, stillbirths, and offspring mortality at the highest dose tested. When offspring were tested postweaning (postnatal day 49), adverse effects on behavior (decreased open field activity) were observed at all doses. A no-effect dose for adverse developmental effects was not identified; plasma exposures (AUC) at the lowest dose tested were lower than that in humans at the MRHD.
Patients randomized to the intervention will undergo early catheter ablation with pulmonary vein isolation as treatment for AF. Catheter ablation should be conducted within 6 weeks of randomization.
PROBLEM TO BE SOLVED: To obtain the subject inhibitor mass-producible at a low cost by chemical synthesis by including a specific isocarbacyclin derivative as an active ingredient therein. SOLUTION: This inhibitor is obtained by including a 15R-isocarbacyclin derivative represented by formula I (R1 is a 1-6C hydrocarbon chain; R2 is H or a protecting group) as an active ingredient. For example, 15R-16-m- tolyl-17,18,19,20-tetranorisocarbacyclin (methyl ester) represented by formula II is preferred as the derivative. The inhibitor can be administered to a human or an animal by, e.g. intravenous injection, percutaneous injection or oral administration. The inhibitor can be prepared into a tablet, a powder, a solution, an emulsion, a capsule, a parenteral injection, etc. by including the isocarbacyclin derivative at >=5 μM concentration and formulating the derivative together with a filter, an extender, a binder, a humectant, a disintegrator, a surface-active agent, a diluent, an excipient, etc.
Isatuximab treatment at a dose of 10 mg/kg by intravenous route. The first injection of isatuximab will be performed at randomization (month 6 +/- 2 days). A second injection may be performed at day 15 if the reticulocytes \<10 G / L, and a third at day 29 if reticulocytes \<10 G / L. Patients will be assessed on day 1, day 15, day 29, day 45, 2 months, 3 months, 6 months and 9 months after randomization.
Compared to the general population, subjects \>50 years of age with new-onset diabetes (DM) are 8-times more likely to have pancreatic cancer (PaC). The likelihood of PaC in new-onset DM is further increased in those who have weight loss or elevated CA19-9. In this study patients with newly diagnosed diabetes will be prospectively identified. Those with weight loss and/or elevated pancreatic cancer marker (CA 19-9) will undergo pancreatic imaging. All subjects will be followed up to 24 months. If successful in identifying surgically removable PaC, this study will fundamentally change our practice and will be a major breakthrough in PaC treatment and research.
Subjects randomized to the placebo group will undergo the same procedure but will only receive 10mL of injectable preservative-free normal saline. This will be the only treatment.
Ciprofloxacin otic solution, 0.2% contains the synthetic antimicrobial agent ciprofloxacin hydrochloride. Ciprofloxacin otic solution, 0.2% is a sterile, preservative-free solution for otic use. Each single-dose container of ciprofloxacin otic solution, 0.2% delivers 0.25 mL of solution equivalent to 0.5 mg of ciprofloxacin. The inactive ingredients are povidone, glycerin, and water for injection. Sodium hydroxide and/or lactic acid may be added to adjust pH.

Ciprofloxacin, a fluroquinolone is available as the monohydrochloride, monohydrate salt of 1cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its molecular formula is C17H18FN3O3•HCl•H2O, and molecular weight is 385.82.

The chemical structure of ciprofloxacin hydrochloride is:
INTRODUCTION: ST waveform analysis (STAN) was introduced as an adjunct to cardiotocography (CTG) to improve neonatal and maternal outcomes. The aim of the present study was to quantify the efficacy of STAN vs CTG and assess the quality of the evidence using GRADE.
MATERIAL AND METHODS: We performed systematic literature searches to identify randomized controlled trials and assessed included studies for risk of bias. We performed meta-analyses, calculating pooled risk ratio (RR) or Peto odds ratio (OR). We also performed post hoc trial sequential analyses for selected outcomes to assess the risk of false-positive results and the need for additional studies.
RESULTS: Nine randomized controlled trials including 28 729 women were included in the meta-analysis. There were no differences between the groups in operative deliveries for fetal distress (10.9 vs 11.1%; RR 0.96; 95% confidence interval [CI] 0.82-1.11). STAN was associated with a significantly lower rate of metabolic acidosis (0.45% vs 0.68%; Peto OR 0.66; 95% CI 0.48-0.90). Accordingly, 441 women need to be monitored with STAN instead of CTG alone to prevent one case of metabolic acidosis. Women allocated to STAN had a reduced risk of fetal blood sampling compared with women allocated to conventional CTG monitoring (12.5% vs 19.6%; RR 0.62; 95% CI 0.49-0.80). The quality of the evidence was high to moderate.
CONCLUSIONS: Absolute effects of STAN were minor and the clinical significance of the observed reduction in metabolic acidosis is questioned. There is insufficient evidence to state that STAN as an adjunct to CTG leads to important clinical benefits compared with CTG alone.
At the time of the injury, participants will be given guided activity instructions regarding what activities to consider and how to observe for increases in symptoms. The focus will be on guided activity and not on restriction. Symptoms will be assessed at the end of each day. Once the patient has been asymptomatic for 24 hours or within 85% of their baseline symptom score (BSS) they will begin the enhanced graded exertion progression (Zurich/Berlin protocol). This protocol will follow the Zurich/Berlin guidelines, but will be enhanced to include sports and skill specific activities. Each step will be completed on a separate day. A medical professional will determine the symptom status of the athlete and when the graded exertion will begin.
Recommendations on the use of acupuncture in managing low back pain (LBP) vary across different guidelines. The methodological quality of existing systematic reviews and meta-analyses on this topic also demonstrates considerable diversity, potentially leading to biased conclusions. Therefore, we comprehensively searched PubMed, EMBASE, Web of Science, Cochrane Database of Systematic Reviews, and Chinese National Knowledge Infrastructure (CNKI) databases and conducted an umbrella review. Scrutiny was performed to ascertain whether primary studies within the systematic reviews and meta-analyses adhered to our inclusion criteria, followed by a meticulous reanalysis of pertinent data. Participant numbers, heterogeneity, publication bias, and excessive significance were taken into account when assessing the credibility of the evidence. For robustness, sensitivity analysis was performed using the leave-one-out method. The results of the umbrella review yielded highly suggestive evidence in favor of the immediate and short-term analgesic effects of acupuncture, with suggestive evidence supporting intermediate-term analgesic effects. However, the effectiveness of acupuncture on disability improvement has demonstrated weak to suggestive evidence. Evidence supporting the enhancement of quality of life by acupuncture is limited. The leave-one-out analysis corroborated the robustness of the meta-analysis, further confirming the credibility of the findings. This umbrella review indicated that the most significant advantage of acupuncture for LBP is its capacity to reduce pain.
Consume 3 servings/day of high fructose corn syrup (HFCS)-sweetened beverage along with the provided ad libitum diet. The 3 HFCS-sweetened beverages will contain 25% of energy requirement and the remainder of the provided diet will contain approximately 125% of energy requirement. All the provided beverage will be consumed for eight weeks. Only the provided beverage and diet will be consumed for eight weeks. The provided diet will be consumed ad libitum and the uneaten portions will be returned to study staff.
Congenital heart defects are significant structural abnormalities affecting the heart and major intrathoracic vessels. They are among the most common birth defects, constituting about one-third of all major congenital anomalies. Many of these defects necessitate surgical intervention during early childhood. Advances in surgical techniques have significantly improved survival rates for patients with congenital heart disease (CHD). However, a variety of systemic complications have become more apparent, including issues affecting the cardiac, pulmonary, gastrointestinal, neurological, and nephrological systems (Walaa El Naga et al., 2022).

Neurological complications greatly contribute to morbidity and mortality in pediatric CHD patients, significantly impacting their neurodevelopmental outcomes. Various studies indicate that up to 30% of children with congenital heart disease (CHD) experience neurological complications. Seizures are the most frequently reported neurological complication, accounting for approximately 70% of cases with neurological sequelae (Aly El Kazaz et al., 2022).

Also Neuropsychological studies of children with complex CHD reveal distinct deficits in intelligence, cognitive performance, executive function, language skills, visuospatial abilities, and attention. (Guo et al., 2021). Recognizing the long-term consequences of accumulated brain injury underscores the importance of identifying and minimizing early insults. (Le H.Sterling et al., 2021) The recognized neurodevelopmental challenges faced by children with CHD prompted the American Heart Association to recommend routine neurodevelopmental evaluations for high-risk patients with CHD. According to the American Heart Association, the initial visit, conducted before 12 months of age, should include a neuromotor examination assessing muscle tone, primitive and deep tendon reflexes, sensory status, and gross motor skills. Although many children with CHD now undergo these recommended neurological examinations, the examinations and their outcomes have not been thoroughly described. Additionally, factors predicting abnormal neurological examination results have not been identified. Enhancing our understanding of the findings from these routinely recommended evaluations will improve the detection of abnormalities, thereby optimizing support for children with CHD and their families.(Le Samantha butler et al., 2023).
Axillary staging in clinically node negative (cN0) breast cancer patients with neoadjuvant systemic therapy (NST; i.e. chemo- and immunotherapy), is preferably performed with sentinel lymph node biopsy (SLNB) after NST. The probability of a tumor-positive SLNB post-NST is low. cN0 patients with Human Epidermal growth factor Receptor 2- positive (HER2+) or triple negative (TN) breast cancer who achieve radiologic complete response (rCR) of the breast on MRI, have the lowest probability of a tumor-positive SLNB post-NST (\<3%). Omitting removal of axillary lymph nodes in clinically node negative patients does not increase the rate of distant metastases nor breast cancer mortality. Performing SLNB can cause short- and long-term morbidity, reducing quality of life. The additional value of performing SLNB in patients with a very low risk of tumor-positive axillary lymph nodes should be investigated.
The objective of this study was to analyse the prevalence, risk factors and need for intervention in a sample of Indian children with choledochal cyst (CDC) complicated by pancreatitis with a special focus on chronic pancreatitis. A retrospective review of medical records of children admitted with CDC over 11 years was done and pancreatitis identified using INSPPIRE guidelines. Children were divided into two groups-one having choledochal cyst alone and the other choledochal cyst along with pancreatitis to determine associated risk factors. 40.2% of children with CDC had pancreatitis based on elevation of enzymes or radiological imaging. Age, total bilirubin and indirect bilirubin, requirement of intervention was significantly higher in the group with pancreatitis. 47% of those with radiological features of pancreatitis had imaging features of chronic pancreatitis. Chronic pancreatitis has not been reported previously in children with CDC and maybe peculiar to the Indian subcontinent.
Rice spotted-leaf mutants serve as valuable resources for studying plant programmed cell death (PCD) and disease resistance mechanisms, making them crucial for research on disease resistance in rice. Map-based cloning was used to identify and clone the spotted-leaf gene OsSPL42. Then, functional complementation and CRISPR/Cas9 techniques were also employed to further validate the function of this gene. By applying leaf clippings for bacterial blight (BB) inoculation, the BB resistance of different rice lines was assessed. The results in this study were as follows: The OsSPL42 behaved as a recessive nuclear gene and was narrowed down to a 111 kb region on chromosome 8. All T0 transgenic rice plants in the complementation experiments exhibited a wild-type phenotype, without any lesion spots on the rice leaves. This suggests that the LOC_Os08g06100 encoding O-methyltransferase is the candidate gene for the mutant spl42. The OsSpl42 is widely expressed and the OsSPL42-GFP protein is mainly localized in the cytoplasm. OsSPL42 overexpression lines are more susceptible to BBs, which indicates that OsSPL42 may act as a negative regulator of rice resistance to BB. In summary, we speculate that OsSPL42 plays an important role in the regulation of pathogen response, providing new insights into plant defense mechanisms.
Treatment with the RA-308 excimer laser and DABRA catheter to treat chronic total occlusions that cannot be crossed with standard guidewires. The catheter and laser are a system, and cannot be used separately.
FIELD: medicine. SUBSTANCE: method involves making hemodilution using crystalloid solutions and administering nitroglycerin and verapamil. Nitroglycerin administration starts at the same time with the preliminary anesthesia beginning by applying a dose being 1.5-2 times as large as the calculated mean dose. Distinct hypotensive action being observed, the dose is lowered to the calculated mean dose. Verapamil is administered as instillation or through automatic syringe starting from the moment the nitroglycerin dose starts lowering. General peripheral vascular resistance, skin temperature, skin heat flow power, pulsometry and hemorrhage in operation wound are used for estimating controllable hypotonia effectiveness. EFFECT: reduced risk of postoperative complications; retained stable arterial blood pressure. 4 cl, 2 tbl
Although exercise interventions for IwD seem to be feasible and well tolerated, resulting in positive effects on ADL functionality for people at mild-to-moderate stages \[1, 2\], the therapeutic role of physical activity, particularly exercise, after dementia diagnosis still needs further evidence \[3-5\], - especially when considering community-based contexts and caregivers as participants on exercise sessions \[6\]. It also matters to highlight that the dose-dependent relationship remains unclear \[1, 7, 8\]. Therefore, research is needed to identify the triad: stage/type of dementia, FITT variables (frequency, intensity, type, and time) of exercise intervention, and target outcome \[7, 9\]. Regarding exercise modality, Multicomponent Training (MT) \[10\] - combining aerobics, strength and balance exercises - seems to be effective at improving functional and cognitive performances in older adults with neurodegenerative disorders, particularly dementia \[11-13\]. Exercise programs previously developed by our group confirmed that a 6-month MT intervention can positively impact the physical and cognitive function of institutionalized older adults with AD \[14, 15\] and can be beneficial in physical fitness and ADL functionality performance among community-dwelling patients \[9, 16\]. However, the extent to which IwD can retain these improvements after the cessation of MT intervention still need to be elucidated \[17\] in order to understand how detraining affects functionality and cognition following the cessation of MT stimulus.

This study is a quasi-experimental controlled trial using a parallel-group design. The study sample consists of community-dwelling individuals aged ≥ 60 years who are clinically diagnosed with dementia or major neurocognitive disorder. Participants will be either allocated into the intervention group or the control group. The intervention group will participate in MT biweekly exercise sessions, whereas the control group will receive monthly sessions regarding physical activity and health-related topics for 6 months. The main outcomes will be physical function as measured by the Short Physical Performance Battery (SPPB) and cognitive function evaluated using the Alzheimer Disease Assessment Scale - Cognitive (ADAS-Cog) at baseline, after 6-months and 3-months after the end of intervention. Secondary outcomes will be body composition, physical fitness, daily functionality, quality of life, neuropsychiatric symptoms and caregiver's burden. Cardiovascular, inflammatory and neurotrophic blood-based biomarkers, and arterial stiffness will also be evaluated in subsamples.
Hospitals that are eligible for the intervention had to be located in an Iowa county classified as non-metropolitan according to rural urban continuum codes (RUCC) 4 through 9 and diagnose or treat at least 100 cancer patients each year. The remaining 5 hospitals meeting this criteria that were not selected for the intervention will serve as controls.
The invention provides a universal swine colibacillosis vaccine and a preparation method thereof, belonging to the technical field of animal bacteria genetic engineering. The vaccine contains the following antigens: the fusion protein formed by periplasm chaperone protein Skp, MltA-related protein MipA and long-chain fatty acid outer membrane transporter Lomt, the B subunit of heat-labile enterotoxin and the B subunit of Shiga toxin 2e, wherein the sequences of the antigens are respectively shown as SEQ ID NO. 4, SEQ ID NO.5 and SEQ ID NO. 6. After the universal swine colibacillosis vaccine is immunized, animals can generate higher IgG and IgA antibodies, and the antibody duration exceeds 120 days. After the vaccine is immunized, the attacks of ETEC F4, F5, F6, F41 and O139 can be simultaneously protected, the protection rate is 100%, the diarrhea phenomenon does not occur, and the protection range is remarkably expanded compared with the existing vaccine.
The RNA binding protein Human Antigen R (HuR) has been identified as a main regulator of the innate immune response and its inhibition can lead to beneficial anti-inflammatory effects. To this aim, we previously synthesized a novel class of small molecules named Tanshinone Mimics (TMs) able to interfere with HuR-RNA binding, and that dampen the LPS-induced immune response. Herein, we present a novel series of TMs, encompassing thiophene 3/TM9 and 4/TM10, furan 5/TM11 and 6/TM12, pyrrole 7b/TM13, and pyrazole 8. The furan-containing 5(TM11) showed the greatest inhibitory effect of the series on HuR-RNA complex formation, as suggested by RNA Electromobility Shift Assay and Time-Resolved FRET. Molecular Dynamics Calculation of HuR - 5/TM11 interaction, quantum mechanics approaches and Surface Plasmon Resonance data, all indicates that, within the novel heteroaryl substituents, the furan ring better recapitulates the chemical features of the RNA bound to HuR. Compound 5/TM11 also showed improved aqueous solubility compared to previously reported TMs. Real-time monitoring of cell growth and flow cytometry analyses showed that 5/TM11 preferentially reduced cell proliferation rather than apoptosis in murine macrophages at immunomodulatory doses. We observed its effects on the innate immune response triggered by lipopolysaccharide (LPS) in macrophages, showing that 5/TM11 significantly reduced the expression of proinflammatory cytokines as Cxcl10 and Il1b.