anthonyyazdaniml/gliner-biomed-curated-corpus huggingface dataset:
The safety and efficacy of entecavir were assessed in a single-arm, open-label trial in 65 subjects who received a liver transplant for complications of chronic HBV infection. Eligible subjects who had HBV DNA less than 172 IU/mL (approximately 1000 copies/mL) at the time of transplant were treated with entecavir 1 mg once daily in addition to usual post-transplantation management, including hepatitis B immune globulin. The trial population was 82% male, 39% Caucasian, and 37% Asian, with a mean age of 49 years; 89% of subjects had HBeAg-negative disease at the time of transplant.  
  
Four of the 65 subjects received 4 weeks or less of entecavir (2 deaths, 1 re-transplantation, and 1 protocol violation) and were not considered evaluable. Of the 61 subjects who received more than 4 weeks of entecavir, 60 received hepatitis B immune globulin post-transplant. Fifty-three subjects (82% of all 65 subjects treated) completed the trial and had HBV DNA measurements at or after 72 weeks treatment post-transplant. All 53 subjects had HBV DNA <50 IU/mL (approximately 300 copies/mL). Eight evaluable subjects did not have HBV DNA data available at 72 weeks, including 3 subjects who died prior to study completion. No subjects had HBV DNA values ≥50 IU/mL while receiving entecavir (plus hepatitis B immune globulin). All 61 evaluable subjects lost HBsAg post-transplant; 2 of these subjects experienced recurrence of measurable HBsAg without recurrence of HBV viremia. This trial was not designed to determine whether addition of entecavir to hepatitis B immune globulin decreased the proportion of subjects with measurable HBV DNA post-transplant compared to hepatitis B immune globulin alone.  
  
If entecavir treatment is determined to be necessary for a liver transplant recipient who has received or is receiving an immunosuppressant that may affect renal function, such as cyclosporine or tacrolimus, renal function must be carefully monitored both before and during treatment with entecavir [see Dosage and Administration (2.4) and Clinical Pharmacology (12.3)].
The present invention relates to products and compositions that may be beneficial in animal husbandry. The products and compositions comprise microorganisms, such as bacteria, in particular probiotic bacteria. Thus, the present invention provides strains of microorganisms, and selection criteria that enable the skilled reader to find other strains useful in the present invention. The strains and compositions comprising the same may be administered to animals, farm animals such as, in particular, pigs. Administration may occur during the first few days of life. By administering the product or composition of the invention, animal growth can be promoted and animal weight can be increased. The compounds or compositions may also prevent or treat infection.
BACKGROUND: The use of antibiotics is essential in the treatment of sepsis and septic shock, and delaying their administration may impact patient mortality outcomes. However, there is currently a controversial debate surrounding this issue. In this meta-analysis, we aimed to explore the association between delayed antibiotic use and mortality in patients with sepsis and septic shock.
METHODS: A systematic search was conducted on PubMed, EMBASE, Web of Science, and Cochrane Library to identify relevant studies published from 2013 to 2023. These studies focused on patients with sepsis or septic shock and provided information on various antibiotic administration times and mortality rates. Two independent reviewers screened and extracted the data. The quality of each study was assessed using the Newcastle-Ottawa Scale, and the collected data were analyzed using STATA 15.1 software.
RESULTS: A total of 29 studies were included, consisting of 17 prospective cohort studies and 12 retrospective cohort studies. The meta-analysis showed that compared to administration of antibiotics within 1 h, each hour of delay in antibiotic administration increased the in-hospital mortality (IHM) (OR = 1.041, 95 % CI: 1.021-1.062), and ministration of antibiotics after 1 h increased the IHM (OR = 1.205, 95 % CI: 1.123-1.293). There was no significant change in the 28-day mortality (OR = 1.297, 95 % CI: 0.882-1.906), 90-day mortality (OR = 1.172, 95 % CI: 0.846-1.622), and 1-year mortality (OR = 0.986, 95 % CI: 0.422-2.303). Administration of antibiotics within 3 h may reduce the IHM (OR = 1.297, 95 % CI: 1.011-1.664, p = 0.041), while administration of antibiotics within 6 h showed no significant association with the IHM.
CONCLUSION: The administration of antibiotics beyond 1 h after emergency triage or disease identification is strongly associated with an increased IHM in patients with sepsis or septic shock, and each hour of delay in antibiotic administration may be associated with an increase in the IHM. Furthermore, the use of antibiotics identification beyond 3 h after emergency triage / sepsis or septic shock may also increase the IHM.
Participants will receive a single oral dose of 5 mg midazolam on Day 1. Participants will receive a dose of INDV-2000 twice a day (BID) from Days 2 to 15. On Day 15 participants will also receive a single oral dose of 5 mg midazolam co-administered with the INDV-2000 morning dose.
Problematic alcohol use, including alcohol use disorders (AUD) and high episodic drinking (HED), remains a public health crisis among college students, particularly those from underserved minority groups. Less likely to disclose alcohol use, underserved minority college students participate in riskier drinking, attributed to multiple social factors, including racial/ethnic discrimination, financial strain, and neighborhood disadvantage. Faced with worse alcohol health-related consequences, effective interventions to reduce alcohol use among this population is critically needed. To reduce alcohol-related health disparities, the investigators aim to develop a public health-based, comprehensive program (Alcohol Awareness Peer Leaders) that will train underserved minority non-traditional health professional students to conduct alcohol screening, brief intervention, and referral to treatment (SBIRT) by using a culturally sensitive approach and screening tool (Rapid Alcohol Problems Screen - RAPS4-QF). By utilizing a culturally adapted SBIRT curriculum, AAPLs will be able to deliver alcohol education and messaging to motivate alcohol risk reduction and decrease in consumption for non-traditional college students studying at a predominantly minority academic institution in an underserved area. The Andersen Healthcare Utilization Model will be utilized to guide this intervention. This theoretically and culturally tailored proposed project is evidence-informed and promising for underserved minority college students and will be advanced through the following three aims: 1) Using an explanatory-sequential mixed methods design, examine a) alcohol consumption and HED patterns, b) attitudes toward alcohol use, c) social and environmental factors, and d) alcohol-related consequences among minority health professional students, 2) Through training of minority health professional students as Alcohol Awareness Peer Leaders (AAPLs), assess the acceptability and relevance of a peer-based SBIRT that was culturally-tailored based on Aim 1 findings, and 3) To compare the feasibility and effectiveness of delivering a culturally-tailored SBIRT using RAPS4-QF by AAPLs by race/ethnicity, drinking status (abstainer vs. drinker), and adverse life experiences. These outcomes will result in the training of 208 underserved minority AAPLs who will conduct culturally competent and evidence-based alcohol screening, brief intervention, and treatment referral for over 2000 students. The result of this innovative proposal will produce future healthcare professionals who will be a valuable community resource for underserved areas as they can continue to decrease alcohol health disparities for underrepresented minority populations, inducing sustainability.
Heart disease kills more than half a million people in the U.S. each year. Atherosclerosis, the major cause of heart disease, is thought to relate to dysregulated inflammation in the cardiovascular system and possibly results from over production of reactive oxygen species (ROS). The rate of atherosclerosis in patients with disorders of the immune system has not been well characterized but is likely to be dramatically different than that seen in the general population. Specifically, patients with Chronic Granulomatous Disease (CGD) may be protected from developing atherosclerosis due to reduced superoxide and other ROS production by phagocytic cells. We hypothesize that patients with CGD are at decreased risk of developing atherosclerosis. The primary objective of this study is to determine the prevalence of atherosclerosis and it s inflammatory characteristics in these and other patients with in-born disorders of immune function. The primary objective will be assessed using carotid studies and other imaging techniques to measure coronary artery calcium scores and the presence or absence of soft plaque. Secondary endpoints include physiologic characteristics such as blood pressure as well as circulating biomarkers associated with heart disease such as C-reactive protein and lipid profile. This study may lead to improved understanding of the pathophysiology of atherosclerosis, specifically the role of free radical stress, and could lead to novel therapies for atherosclerosis that may benefit patients with immune disorders and the general population.
Palliative chemotherapy has been shown to improve survival compared with best supportive care alone in patients with unresectable or recurrent gastric cancer. There is no standard second-line chemotherapy for advanced gastric cancer and no randomized-controlled trial data suggest a benefit of second-line chemotherapy compared with supportive care alone. Response rates of second-line therapy in phase II trials are similar to those seen for other cancers that are more commonly retreated. Combination therapy may achieve higher response rates than single agents, however, the survival outcome are the same. In addition, data suggest that patients may obtain symptomatic benefits from second-line therapy. In comparison to the toxicity profile of single agent with combination regimen, patients are more tolerable to single agent therapy than combination.

Based on the previous clinical experience in second line chemotherapy of advanced gastric cancer, the single agent of PEP02, irinotecan and docetaxel are selected as the regimens for this randomized phase II study. The efficacy and toxicity outcome of the three-arm design will be a valuable reference for future combination therapy or phase III study design.
BACKGROUND: Despite improved visualization, the use of arthroscopic surgery to perform the Latarjet procedure has not decreased the rates of complications and glenohumeral osteoarthritis (OA) in the long term. Many of the reported complications are related to the use of screws for bone block fixation with freehand drilling.
PURPOSE: To evaluate the long-term (at a minimum 10-year follow-up) clinical and radiological outcomes of the arthroscopic Bristow-Latarjet procedure using a posterior guided drilling technique and suture button for coracoid bone graft fixation.
STUDY DESIGN: Case series; Level of evidence, 4.
METHODS: Consecutive patients who underwent the arthroscopic Bristow-Latarjet procedure with suture button fixation between 2011 and 2013 were reviewed by 2 independent evaluators. Complications and revision surgery were recorded, and we evaluated patient-reported outcomes including subjective scores, recurrence of shoulder instability (dislocation or subluxation), range of motion limitations, and return to sports. Patients had radiographs taken at least 10 years after surgery to assess glenohumeral OA according to the Samilson-Prieto classification system and computed tomography scans to assess bone block positioning and healing.
RESULTS: A total of 65 consecutive patients (68 shoulders) with a mean follow-up of 135 months (range, 120-156 months) were included. The mean age at the time of surgery was 25 ± 8 years; 7 patients had previous failed Bankart repair. At follow-up, 94% (64/68) of the shoulders had no recurrence of instability. The 4 cases of instability recurrence were traumatic and occurred at 3 weeks (a fall), 4 months, 2 years, and 7 years after surgery. No hardware failures, coracoid fractures, or neurological complications were observed. Overall, 61 patients (94%) were still participating in sports, with 44 (68%) at the same or higher level. Range of motion showed nonsignificant restrictions in external rotation with the arm at the side (7° ± 9°) and with the arm at 90° of abduction (9° ± 10°) compared with the contralateral side. Additionally, 11 shoulders (16%) had some residual anterior apprehension on clinical examination. At last follow-up, 77% (47/61) of the shoulders had no OA development or progression. Previous failed Bankart repair was a risk factor for the development of OA. Patients with OA had significantly lower Subjective Shoulder Value scores (79% vs 91%, respectively; P = .01) and decreased external rotation with the arm at the side (40° vs 65°, respectively; P = .001) compared with patients with no or little OA.
CONCLUSION: The arthroscopically guided Bristow-Latarjet procedure with suture button fixation is a safe and durable surgical treatment method for recurrent anterior shoulder instability, allowing a high rate of return to sports without significant motion restrictions and no or little OA in the long term.
The safety and effectiveness of HECTOROL capsules were evaluated in two double-blind, placebo-controlled, multicenter clinical studies (Study A and Study B) in a total of 138 patients with CKD on hemodialysis. Patients in Study A were an average age of 52 years (range: 22 to 75), were 55% male, and were 58% African-American, 31% Caucasian, and 11% Hispanic, and had been on hemodialysis for an average of 53 months. Patients in Study B were an average of 52 years (range: 27 to 75), were 45% male, and 99% African-American, and 1% Caucasian, and had been on hemodialysis for an average of 56 months. After randomization to two groups, eligible patients underwent an 8-week washout period during which no vitamin D derivatives were administered to either group. Subsequently, all patients received HECTOROL capsules in an open-label fashion for 16 weeks followed by a double-blind period of 8 weeks during which patients received either HECTOROL capsules or placebo. The initial dose of HECTOROL capsules during the open-label phase was 10 mcg after each dialysis session (3 times weekly) for a total of 30 mcg per week. The dosage of HECTOROL was adjusted as necessary by the investigator to achieve intact PTH levels within 150 pg/mL to 300 pg/mL. The maximum dosage was limited to 20 mcg after each dialysis session (60 mcg/week). If at any time during the trial intact PTH fell below 150 pg/mL, HECTOROL was immediately suspended and restarted at a lower dosage the following week. Mean weekly doses during the 16-week open-label period ranged from 15 mcg to 29 mcg in Study A and from 19 mcg to 28 mcg in Study B.

One hundred and six (77%) of the 138 patients who were treated with HECTOROL capsules during the 16-week open-label phase achieved intact PTH levels ≤300 pg/mL. Ninety-four (68%) of these patients exhibited plasma intact PTH levels ≤300 pg/mL on at least 3 occasions. Eighty-seven (63%) patients had plasma intact PTH levels <150 pg/mL on at least one occasion during the open-label phase of study participation.

Decreases in plasma intact PTH from baseline values were calculated using as baseline the average of the last 3 values obtained during the 8-week washout phase and are displayed in Table 5.

HECTOROL capsules treatment resulted in a statistically significant reduction from baseline in mean intact PTH levels during the 16-week open-label treatment period in more than 94% of the 138 treated patients. During the double-blind period (weeks 17 to 24), the reduction in mean intact PTH levels was maintained in the HECTOROL capsules treatment group compared to a return to near baseline in the placebo group.
PURPOSE:NINJIN-TO (a Chinese herb tea) composed of KANZO (root of Glycyrryhiza glabra), SHOKYO (rhizome of Zingiber officinale, JUTSU (rhizome of Atractylodes lancea) and NINJIN (rhizome of Panax ginseng) is used as a carcinostatic agent free from side effects. CONSTITUTION:NINJIN-TO is used as a carcinostatic agent. It has been found that NINJIN-TO used as a Chinese herb tea for the diseases such as acute or chronic digestive disorder has carcinostatic effect. For example, 3g of KANZO, 3g of SHOKYO, 3g of JUTSU and 3g of NINJIN are decocted with 600ccof water according to the traditional method to obtain 350cc of decoct, the dregs are removed, and the liquid is administered as a carcinostatic agent 3 times a day, or the liquid is used as a Chinese extract drug. The agent increases the survival ratio of ICR male mouse of Ehrlich ascites carcinoma. Furthermore, it has extremely low toxicity and high safety.
The invention relates to the field of a traditional Chinese medicine, in particular to a medicine used for preventing and curing postpartum hypogalactia. The medicine is prepared from the following Chinese traditional medicaments by weight part: 5 to 15 parts of angelica, 5 to 20 parts of ricepaperplant, 10 to 30 parts of radix astragali, 5 to 15 parts of cow soapwortseed, 5 to 15 parts of finger citron, 5 to 15 parts of pangolin or Sweetgum Fruit. In order to improve the effect, 10 to 20 parts of dangshen can be added to the raw materials when the medicine is used for curing deficient qi and blood. 6 to 12 parts of green tangerine orange peel, 6 to 15 parts of radix bupleuri and 6 to 15 parts of balloonflower can be added to the raw materials when the medicine is used for curing stagnation of the liver-qi and stagnation of qi. The medicine is a medicament form referred to in any pharmacy, and can be used for preparing capsules, granule, oral liquid or tablets. The medicine has unique efficiency, and remarkable clinic curative effect, which is safe without apparent toxic and side effect. The medicine is very practically significant for deep research and development of preparation of Chinese traditional medicaments, modernization of Chinese traditional medicaments, and promoting Chinese traditional medicaments internationally.
Participants receive a Zephyr ZSI 475 FTM internal erection prosthesis device as the current standard of care in our hospital. A healing phase of at least six weeks is respected.
Risk Summary

There are no adequate data on the developmental risk associated with the use of XADAGO in pregnant women. In animals, developmental toxicity, including teratogenic effects, was observed when safinamide was administered during pregnancy at clinically relevant doses. Developmental toxicity was observed at doses lower than those used clinically when safinamide was administered during pregnancy in combination with levodopa/carbidopa.

The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data

Animal Data

In an embryofetal development study in rats, oral administration of safinamide (0, 50, 100, or 150 mg/kg/day) throughout organogenesis resulted in dose-related increases in fetal abnormalities (primarily urogenital malformations) at all doses. A no-effect dose for adverse effects on embryofetal development was not established. The lowest dose tested (50 mg/kg/day) is approximately 5 times the maximum recommended human dose (MRHD) of 100 mg on a body surface area (mg/m 2) basis. In a combination embryofetal development study of safinamide and levodopa (LD)/carbidopa (CD) in rats (80/20 mg/kg/day LD/CD in combination with 0, 25, 50, or 100 mg/kg/day safinamide or 100 mg/kg/day safinamide alone), increased incidences of fetal visceral and skeletal malformations and variations were observed at all doses of safinamide in combination with CD/LD and with safinamide alone. The lowest dose of safinamide tested (25 mg/kg/day) is approximately 2 times the MRHD on a mg/m 2 basis. 

In embryofetal development studies in rabbits, no developmental toxicity was observed at up to the highest oral dose of safinamide tested (100 mg/kg/day). However, when safinamide (0, 4, 12, or 40 mg/kg/day) was administered throughout organogenesis in a combination study of safinamide with LD/CD (80/20 mg/kg/day LD/CD), there was an increased incidence of embryofetal death and cardiac and skeletal malformations, compared to LD/CD alone. A no-effect dose for safinamide was not established; the lowest effect dose of safinamide tested (4 mg/kg/day) is less than the MRHD on a mg/m 2 basis. 

In a rat pre- and postnatal development study, oral administration of safinamide (0, 4, 12.5, or 37.5 mg/kg/day) throughout pregnancy and lactation resulted in skin discoloration of the offspring, presumed to be due to hepatobiliary toxicity, at the mid and high doses and decreased body weight and increased postnatal mortality in offspring at the highest dose tested. The no-effect dose (4 mg/kg/day) for adverse developmental effects is less than the MRHD on a mg/m 2 basis.
Despite significant advancements in cancer treatment in recent decades, the high mortality rate associated with lung cancer remains a significant concern. The development and proper execution of new targeted therapies needs more deep knowledge regarding the lung cancer associated tumour microenvironment. One of the key component of that tumour microenvironment is the lung resident macrophages. Although in normal physiological condition the lung resident macrophages are believed to maintain lung homeostasis, but they may also initiate a vicious inflammatory response in abnormal conditions which is linked to lung cancer development. Depending on the activation pathway, the lung resident macrophages are either of M1 or M2 sub-type. The M1 and M2 sub-types differ significantly in various prospectuses, from phenotypic markers to metabolic pathways. In addition to this generalized classification, the recent advancement of the multiomics technology is able to identify some other sub-types of lung resident macrophages. Researchers have also observed that these different sub-types can manipulate the pathogenesis of lung carcinogenesis in a context dependent manner and can either promote or inhibit the development of lung carcinogenesis upon receiving proper activation. As proper knowledge about the role played by the lung resident macrophages' in shaping the lung carcinogenesis is limited, so the main purpose of this review is to bring all the available information under the same roof. We also elaborated the different mechanisms involved in maintenance of the plasticity of M1/M2 sub-type, as this plasticity can be a good target for lung cancer treatment.