anthonyyazdaniml/gliner-biomed-curated-corpus huggingface dataset:
Following oral administration of a 500 mg dose of valacyclovir hydrochloride to 5 nursing mothers, peak acyclovir concentrations (Cmax) in breast milk ranged from 0.5 to 2.3 times (median 1.4) the corresponding maternal acyclovir serum concentrations. The acyclovir breast milk AUC ranged from 1.4 to 2.6 times (median 2.2) maternal serum AUC. A 500 mg maternal dosage of valacyclovir hydrochloride twice daily would provide a nursing infant with an oral acyclovir dosage of approximately 0.6 mg/kg/day. This would result in less than 2% of the exposure obtained after administration of a standard neonatal dose of 30 mg/kg/day of intravenous acyclovir to the nursing infant. Unchanged valacyclovir was not detected in maternal serum, breast milk, or infant urine. Caution should be exercised when valacyclovir hydrochloride is administered to a nursing woman.
BACKGROUND: Gene and RNA therapies have potential to transform the treatment of rare inherited diseases, but there are concerns about the evidence supporting their use and high costs.
OBJECTIVE: We analyze the evidence supporting Food and Drug Administration (FDA) approval of gene and RNA therapies for rare inherited diseases and discuss implications for clinical practice and policy.
METHODS: We conducted a qualitative analysis of FDA documents outlining the basis of approval for gene and RNA therapies approved for rare inherited diseases between 2016 and 2023. For each drug, we gathered five characteristics of the evidence supporting FDA approval (no phase 3 trial, nonrandomized, no clinical endpoint, lack of demonstrated benefit, and significant protocol deviation) and four characteristics of the FDA approval process (prior rejection or complete response, negative committee vote, discrepancy between label and trial population, and boxed warning). The main outcome was the number of drugs with each characteristic.
RESULTS: Between 2016 and 2023, 19 gene and RNA therapies received FDA approval to treat rare inherited diseases. The most common limitations in the evidence supporting approval of these drugs were nonrandomized studies (8/19, 42%), no clinical endpoint (7/19, 37%), lack of demonstrated benefit or inconsistent results (4/19, 21%), and no phase 3 trial (4/19, 21%). Half (3/6) of accelerated approvals and 57% (5/9) of drugs with breakthrough designation had nonrandomized trials, and gene therapies with one-time dosing were overrepresented (5/7, 71%) among the drugs with nonrandomized trials. Five of six accelerated approvals (83%) and five of nine pediatric drugs (56%), most of which were indicated for Duchenne muscular dystrophy, had no clinical endpoint. Four of nine (44%) pediatric drugs and four of six (67%) accelerated approvals failed to demonstrate benefit compared with none of the nonpediatric drugs and none of the traditional approvals. Five drugs, which all had different indications and represented a mix of RNA and gene therapies, did not have any of these evidence characteristics. Among drugs that received prior rejections or negative committee opinions, all four had nonrandomized trials and lacked a clinical endpoint, and 75% (3/4) lacked demonstrated benefit. Five of nine (56%) pediatric drugs were indicated for broader age groups according to the drug label compared with the trial populations. Of the three drugs with boxed warnings, two had pediatric indications and nonrandomized studies, and one had no phase 3 trial.
CONCLUSIONS: Issues related to trial design, outcome, and data integrity in the evidence supporting FDA approval of rare inherited disease gene and RNA therapies raise questions about whether this evidence is adequate to inform prescribing decisions. Gene and RNA therapies with accelerated approval and pediatric indications were overrepresented among drugs lacking clinical endpoints or demonstrated benefit and should be the focus of efforts to reduce uncertainty in the evidence.
Participants will be observed for 12 months. Participants will use the Health in Motion app to set goals and keep track of their health and health events, including falls. These participants will NOT receive the education modules or the exercise program.
PURPOSE: A prevention of salmonella typhimurium infection and treating method are provided to be a nature-friendly due to usage of bacteriophage from nature as an active ingredient of composition. CONSTITUTION: A prevention of salmonella typhimurium infection and treating method comprise a bacteriophage STP-1 having the sequence number of 1 as separated from the nature, or a plasmodium thereof as an active ingredient. The bacteriophage STP-1 may have a deposition number KCTC 12012BP. The composition is used for a feed additive, a drink additive, or a use for manufacturing disinfectant. The prevention of salmonella typhimurium infection and treating method comprise the step of injecting composition of salmonella typhimurium anti-infection and disposition to an animal. The composition is injected to animal as the use for the feed additive, the drink additive, or the disinfectant.
The study will enroll 9-21 participants diagnosed with recurrent or refractory CD19 positive B-cell malignant tumors, including acute B-lymphocyte leukemia, B-cell non-Hodgkin's lymphoma and chronic B-lymphocyte leukemia. There will be three preset dose groups in this clinical trial, which are 1.0×10\^7、2.0×10\^7 and 3.0×10\^7 CAR positive NK cells / kg (body weight), SRC will discuss and decide the next infusion plan. Participants will be enrolled from low dose group to high dose group, each dose will enroll at least 3 cases. Dose escalation will be decided by the SRC (Safety Review Committee) separately by diseases. There will be expanded cases in the aim dose group, which will at most to 6 cases. The protocol will be performed into screening period (-30\~-10 days), prophase of lymophodepletion (-10\~-5 days), Lymophodepletion (-5\~-3 days), pre-infusion evaluation (-2\~-1 days), infusion (day 0), and follow-up period (1-720 days). According to the administration strategy, we will start from single administration. Only after the SRC's decision based on safety and PK data, we could explore further on multiple administrations or combo therapy strategy.
The common cattle tick Rhipicephalus microplus causes severe limitations to livestock production. Bovine genetics could be a decisive component for the success or failure of control programs for ticks and diseases transmitted. The objective of this work was to detect chromosomal regions associated with host resistance to R. microplus through an associative mapping study using medium and high density microarrays in a population of Argentine Creole cattle. The phenotypic record of the number of ticks that completed their development on the host, after artificial infestations, was obtained during 2015 to 2020. Genomic DNA was extracted for genotyping from 192 animals using Affymetrix high (Axiom™ Bos 1) and medium density (ArBos1) microarrays. In an exploratory study, chromosomal regions containing putative quantitative trait loci (QTLs) were recognized on chromosomes 27, 11, 10, 9, 16, 13, 3, 19, 8 and 18, associated with the variation of R. microplus load. Gene ontology based on genes located on these regions revealed an enrichment of terms and pathways for the immune system, blood coagulation, tissue regeneration, endopeptidase activity and protein phosphorylation. The information obtained in this work constitutes a first report of QTLs for tick count in the Argentine Creole cattle, and contributes with the knowledge about the underlying process involved in tick resistance.
<P>PROBLEM TO BE SOLVED: To provide an antihypertensive agent and foods and drinks, causing no side effect, daily easily ingestible, and having high preventing and improving effects for hypertension.  <P>SOLUTION: The antihypertensive agent and foods and drinks usable for preventing and improving hypertension are obtained by including components extracted from culture products obtained by culturing mycelium of Basidiomycete in a medium containing vegetable fibrous material. The extracted components preferably contain saccharide, protein, and water-soluble lignin. The vegetable fibrous material is preferably prepared from true grasses more preferably prepared from one or more selected from bagasse, maize foliage, wheat bran, rice bran, rice straw, cogon, striped bamboo, and bamboo. and as the basidiomycete, Ganoderma lucidum, Poria cocos, Ganoderma applanatum, Coriolus versicolor, Cortinellus shiitake, Pleurotus ostreatus, Grifola frondosa, Flammulina velutipes, Lyophyllum aggregatum, Hericium erinaceum, Agaricus blazei Murill and the like are used.  <P>COPYRIGHT: (C)2007,JPO&INPIT
In previous prospective research, psychological stress has been shown to slow the healing of small superficial wounds and impair surgical healing. We will investigate whether a psychological intervention to reduce stress can improve surgical healing.

Ninety patients undergoing elective laparoscopic cholecystectomy will be randomised to receive either standard care or a brief pre-surgical psychological intervention plus standard care. Patients will complete a pre-surgical questionnaire to assess stress, anxiety, depression, illness perceptions and current health, at least 3 days prior to surgery. Then the intervention will be delivered. A second questionnaire on the morning of surgery will reassess stress, anxiety and illness perceptions to see whether the intervention has reduced stress and increased control perceptions. Plasma catecholamines and salivary cortisol will be tested to assess the effectiveness of the intervention in reducing stress-related hormones and to investigate their role in wound healing. During surgery 2 small expanded polytetrafluroethylene tubes will be inserted in the wound, which will be removed after 7 days. Wound healing will be assessed by hydroxyproline and total protein deposition in the tubes, as well as by the presence of wound infection. Patients' post-surgical recovery, including pain and fatigue, will also be assessed. If this brief psychological intervention can improve wound healing and aid recovery, it would provide a simple strategy to improve outcomes in surgery.
Saline 2ml will be supplied in pre-filled syringes within numbered trial treatment packs. The trial will be double-blind; patients, investigators, and the clinical team will be blinded. Only the pharmacy providing the numbered syringes will be aware of the allocation but will not be involved with clinical care or outcome evaluation. The saline placebo will be stored in syringes identical to the naloxone syringes without identifying features.
Systems and methods of exchanging Healthcare Quality Measures (HQM) are disclosed. Healthcare providers can define one or more HQMs by constructing expressions using an expression builder according to a funding organization's requirements. The expression builder advantageously allows the Healthcare provider to build measure expressions without the need to know a complex programming language. Once a measure is derived, it can be converted to a common HQM data format and exchanged with the organization via an intermediary HQM service. The HQM data can then be converted into the organization's proprietary format. Thus, HQM data exchanges among providers and organizations are simplified.
We aim to investigate the methylation of NR3C1 gene promotor and NR3C1 BclI polymorphism in schizophrenia (SCZ) patients with attempted suicide or non-suicidal self-injury (NSSI). A sample of 112 patients with SCZ was included in the study. Structured Clinical Interview for Diagnostic and Statistical Manual-Fourth Edition Axis I Disorders was used to confirm the diagnosis according to The Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision criteria. The patients were evaluated by data forms that had sociodemographic, suicidal behavior, and NSSI information. Methylation-specific polymerase chain reaction (PCR) was used to identify the methylation of the NR3C1 gene. The analysis of the BclI polymorphism of the NR3C1 gene was evaluated by using the PCR restriction fragment length polymorphism. Our results revealed that although the NR3C1 gene methylation was not statistically significantly different, there was a significant difference in NR3C1 genotype distribution among the SCZ groups with and without attempted suicide. SCZ patients carrying the CC genotype had a lower risk of attempted suicide (Odds Ratio [OR]: 0.421; 95% Confidence Interval [CI]: 0.183-0.970; p = 0.040), while having the GG genotype in SCZ patients was associated with a higher risk of attempted suicide (OR: 3.785; 95% Cl: 1.107-12.945; p = 0.042). Additionally, due to NSSI in SCZ patients, there were no significant differences in NR3C1 gene methylation and NR3C1 genotype distribution among the groups. We propose that the NR3C1 BclI polymorphism may be associated with attempted suicide in Turkish patients diagnosed with SCZ.
The nutrition education group receive the intervention first, which include 2 nutrition lessons about osteoporosis and calcium and calcium rich foods. The 2 lessons are delivered in one week for 2 hours each lesson. After this week, participants in the intervention group receive handouts about osteoporosis and calcium once a week for a period of 4 weeks.
The "Activity Program for Learning Self-Care Skills", which was prepared by the educator after receiving expert opinions, was applied individually to each child in the intervention group for 12 weeks. The training was 1 day a week for 40 minutes.
Patients in this group will receive PNS during surgery, with the train-of-four (TOF) maintained at a level of 0. Additionally, to ensure complete blockade of the neuromuscular system, the Post-Tetanic Count (PTC) will be monitored and maintained at less than or equal to 3 simultaneously.
The obesity epidemic has led to an increased prevalence of obesity-related glomerulopathy (ORG). This disease is characte-rized by proteinuria, glomerulomegaly, progressive glomerulosclerosis and a decline in renal function. Individuals with obesity frequently display arterial hypertension and diabetes mellitus, exacerbating renal damage. The pathogenesis involves overactivation of the RAAS (Renin-Angiotensin-Aldosterone System), glomerular hyperfiltration, an inflammatory state with oxidative stress, hyperinsulinemia-induced hemodynamic alterations and lipotoxicity. Additionally, obesity represents a significant risk factor for kidney stone formation, further contributing to renal damage. The management of obesity-induced nephropathy primarily involves weight reduction strategies and optimized control of blood pressure and metabolic factors. Early detection is crucial to counteract the progression of kidney disease. Noteworthy, obesity significantly complicates the implementation of renal replacement procedures, including kidney transplantation, and increases the rate of complications. In summary, there are many reasons why obesity should gain attention in the field of nephrology.
NEW MATERIAL:A compound of the formula (R is H, CH3 or C2H5). The physico-chemical properties of the compound in which R is H are as follows: Molecular weight: 350. Molecular formula: C17H18O8. Melting point: 140-145 deg.C and 165-168 deg.C (double melting points). Solubility: Soluble in 5% NaHCO3 and slightly soluble in organic solvents, e.g. chloroform. Toxicity: No toxicity is caused even by the continuous administration in a dose of 100mg/kg to mice. USE:A carcinostatic agent, having improved activity with low toxicity, and orally and parenterally administrable. PROCESS:A microorganism, belonging to the genus Penicillium, and having the ability to produce the compound of the formula, e.g. Penicillium islandicum Sopp IFO-5232, IFO-5235, IFO-5731 or IFO-6019, is cultivated in a culture medium at 4-8pH, preferably near neutral 7pH, by the plate stationary culture method at 20-30 deg.C for 10-15 days. The produced compound is then adsorbed from the filtrate in active carbon, desorbed with acetone and treated with an organic solvent to give the compound of the formula.
A composition and use of a composition comprising a glycoside of a mono- or diacylglycerol compound and an oil rich in n-3 polyunsaturated fatty acids, e.g. fish oil. The composition may also comprise a rose hip concentrate. The composition is used to treat inflammatory diseases, e.g. joint diseases such as osteoarthrisis, or joint pain and stiffness. By administering the composition on a daily basis, a significant reduction in joint pain and stiffness of the affected joints is achieved, which allows individuals suffering from especially joint diseases to resume daily activities.
<P>PROBLEM TO BE SOLVED: To provide an active ingredient capable of inducing an inactive-type latent TGF(transforming growth factor)b to active-type TGFb.  <P>SOLUTION: The active ingredient is a natural extract having the above-mentioned activity. The natural extract is a plant-derived extract such as soybean extract or oat(Avena sativa) extract or an animal-derived extract such as silk extract, fish roe extract or fish meal extract. This active ingredient can be used for producing a composition that increases active-type TGFb1 concentrations in the skin( especially corium ). Uses derived from the above use are also provided, including the production of cosmetic compositions or pharmaceutical compositions containing the above extract.  <P>COPYRIGHT: (C)2006,JPO&NCIPI
Objective: To investigate the safety and efficacy of percutaneous superselective superior rectal artery embolization in the treatment of grades Ⅱ-Ⅲ internal hemorrhoids. Methods: The clinical data of 22 patients with grades Ⅱ-Ⅲ internal hemorrhoids who underwent superselective superior rectal artery embolization in the Department of Interventional and Minimally Invasive Tumor Therapy of the Second Hospital of Shandong University from September 2019 to February 2022 were retrospectively analyzed. According to the blood supply artery of hemorrhoids, superselective embolization was performed with embolization materials. The surgical efficacy,postoperative complications,and 12-month follow-up results were analyzed. The clinical score data (French bleeding score,quality of life score,prolapse score) were expressed using the median (Q1, Q3). The clinical scores before and after treatment were compared by the nonparametric rank sum test (Wilcoxon test),and the Z-value was calculated. P-values <0.05 indicate statistically significant differences. Results: The operation was successful in all 22 patients (technical success rate: 100%). The main postoperative side effects and complications included tenesmus (81.8%,18/22),anal bulge (68.2%,15/22),and mild pain in the anus (22.7%,5/22). The above reactions were improved 3-5 days after operation; three patients had congestion and dull pain at the puncture site,which improved spontaneously without treatment. The patients were followed up for 12 months. Compared with those prior to operation, the French bleeding score,quality of life score,and prolapse score were significantly improved (all P<0.05). Conclusion: Superselective superior rectal artery embolization is a relatively safe and low-risk treatment for grades Ⅱ-Ⅲ internal hemorrhoids. It is an option for the treatment of internal hemorrhoids,particularly hemorrhagic internal hemorrhoids.
Participants receive paclitaxel IV over 3 hours on days 1, 8 and 15 and carboplatin IV over 1 hour on day 1. Beginning course 2, participants also receive bevacizumab IV over 1.5 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients 18 years of age or older. Open extremity fracture. Planned definitive fracture management with external fixation, internal fixation, or joint fusion. Open fracture wound management that includes formal surgical debridement within 72 hours of their injury. Will have all planned fracture care surgeries performed by a participating surgeon or delegate. Provision of informed consent.
Patients receive atezolizumab IV over 30-60 minutes on day 1. Patients also receive one of the chemotherapy combinations below depending on their previous therapy and disease. Between the first day of chemotherapy and the first day of cycle 2 of chemotherapy, patients undergo external beam radiation therapy 5 days per week. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning 21 and 90 days after treatment, patients undergo surgery. Within 42 days after completion of surgery, patients then receive atezolizumab IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 17 cycles in the absence of disease progression or unacceptable toxicity. Patients may undergo a PET scan, CT scan, and MRI on study. Patients also undergo tumor biopsies and blood sample collection throughout the trial.
The composition of the algal additive is used in food processing and canning industry and is offered in bulk packaged for individual dosing or according to the user. The bulk composition of the algal additive enables the use of algae as an additive enriching the foods at a temperature below 40?C with natural vitamins, immunostimulants and antioxidants. The additive is easily suspending in liquids. The natural composite materials included in the additive preserve the native state of the algal product, extending their shelf life. The increase of the salt and sugar content in the new composite materials over 60 % has antibacterial, antifungal and insecticidal effect for the algae and algal products. By the addition of ingredients such as mixed salt and Samardala to the algae their fragrance is masked, which improves the quality of the new taste enhancers. The composition of the algal additive contains astaxanthin, which reduces the harmful effect of the salt on the eyes and cardiovascular system and strengthens their antioxidant protection.
Objective: The aim of this study is to evaluate local and systemic photobiomodulation (PBM) in patients with COVID-19-related dysgeusia, with the expectation of improving taste dysfunction. Background: PBM has garnered attention as a potential therapy in long COVID, a condition characterized by many persistent symptoms following the acute phase of COVID-19. Among these symptoms, dysgeusia, or altered taste perception, can significantly affect patients' quality of life. Emerging research suggests that PBM may hold promise in ameliorating dysgeusia by modulating cellular processes and reducing inflammation. Further clinical studies and randomized controlled trials are essential to establish the efficacy and safety of PBM for the treatment of dysgeusia in long COVID, but initial evidence suggests that this noninvasive modality may offer a novel avenue for symptom management. Methods: Seventy patients experiencing dysgeusia were randomly assigned to receive active local and systemic PBM (n = 34) or simulated PBM (n = 36). Low-power laser (red wavelength) was used at 18 spots on the lateral borders of the tongue (3 J per spot), salivary glands (parotid, sublingual, and submandibular glands-3 J per spot), and over the carotid artery for 10 min (60 J). Alongside laser therapy, all patients in both groups received weekly olfactory therapy for up to 8 weeks. Results: Dysgeusia improved in both groups. At weeks 7 and 8, improvement scores were significantly higher in the PBM group than in the sham group (p = 0.048). Conclusions: Combined local and systemic PBM, as applied in this study, proved effective and could serve as a viable treatment option for alleviating dysgeusia in long-COVID patients. Clinical Trial Registration: RBR-2mfbkkk.