anthonyyazdaniml/gliner-biomed-curated-corpus huggingface dataset:
A total of 170 patients participated in a 12-week, randomized, double-blind, placebo-controlled trial conducted to evaluate the efficacy and safety of saxagliptin 2.5 mg once daily compared with placebo in patients with type 2 diabetes mellitus and moderate (n=90) or severe (n=41) renal impairment or ESRD (n=39). In this trial, 98% of the patients were using background antidiabetic medications (75% were using insulin and 31% were using oral antidiabetic medications, mostly sulfonylureas).

  


After 12 weeks of treatment, saxagliptin 2.5 mg provided significant improvement in A1C compared to placebo (Table 13). In the subgroup of patients with ESRD, saxagliptin and placebo resulted in comparable reductions in A1C from baseline to Week 12. This finding is inconclusive because the trial was not adequately powered to show efficacy within specific subgroups of renal impairment.

  


After 12 weeks of treatment, the mean change in FPG was −12 mg/dL with saxagliptin 2.5 mg and −13 mg/dL with placebo. Compared to placebo, the mean change in FPG with saxagliptin was −12 mg/dL in the subgroup of patients with moderate renal impairment, −4 mg/dL in the subgroup of patients with severe renal impairment, and +44 mg/dL in the subgroup of patients with ESRD. These findings are inconclusive because the trial was not adequately powered to show efficacy within specific subgroups of renal impairment.
OBJECTIVE: To investigate the effectiveness of debridement-vacuum sealing drainage (VSD)-modified external fixation antibiotic-impregnated cement semi-open technique in treatment of chronic ulcer wounds.
METHODS: Clinical data of 43 patients with chronic ulcer wounds who met the selection criteria and admitted between January 2019 and June 2023 were retrospectively analyzed. Among them, 23 cases were treated with debridement-VSD-modified external fixation antibiotic-impregnated cement semi-open technique (improved group), and 20 cases were treated with debridement-VSD-traditional antibiotic-impregnated cement technique (control group). There was no significant difference in gender, age, constituent ratio of patients with type 2 diabetes mellitus, constituent ratio of patients with smoking history, body mass index, wound site, and other baseline data between the two groups ( P>0.05). The healing quality and healing time, the positive rate of bacterial culture after bone cement coating, the loosening rate of bone cement, the number of operations, the number of hospitalizations, the length of hospitalization, and the cost of hospitalization were recorded and compared between the two groups.
RESULTS: Compared with the control group, the positive rate of bacterial culture after bone cement coating and the loosening rate of bone cement in the improved group was significantly lower, as well as the number of operations, the number of hospitalizations, the length of hospitalization, and hospitalization cost significantly reduced ( P<0.05). Wound repair was completed in both groups without amputation. The wound healing quality of the improved group was better than that of the control group and the wound healing time was shorter, the differences were significant ( P<0.05). All patients were followed up 1-5 years (mean 3.4 years), and no ulcers recurred during follow-up.
CONCLUSION: Debridement-VSD-modified external fixation antibiotic-impregnated cement semi-open technique in the treatment of chronic ulcer wounds can effectively reduce the loosening rate of bone cement, facilitate the induced membrane formation and wound healing, and significantly reduce the number of operations and shorten the length of hospital stay.
This is a phase I randomized trial assessing the safety, acceptability, and pharmacokinetics of two formulations of MK-2048 vaginal film. While the primary objective is to evaluate the safety of the product, the overarching objective of this study is to provide proof of concept that an antiretroviral drug can be delivered in an extended release film formulation to provide drug delivery for 7 days or more after a single application. Forty eight women will be randomized with equal frequency to receive a single dose of a vaginal film containing MK-2048 (either the high Eudragit® or low Eudragit® formulation). The film will be inserted by a clinician on the day of enrollment. Vaginal swabs and plasma will be collected at days 0, 3, 5, 7, 10, 14 and 28 for all participants. On the day of enrollment, some participants may elect to participate in immediate post insertion sample collection (vaginal swab and plasma) at one or two time points within 6 hours of insertion. Genital biopsy samples and a rectal swab will be obtained on day 7, and cervicovaginal lavage will be collected at screening and days 14 and 28. The primary endpoint is the frequency of Grade 2 or higher adverse events. The secondary endpoints are: MK-2048 concentrations in plasma, cervical tissue homogenate, cervicovaginal lavage fluid, rectal and vaginal swab eluents; self-reported assessment of qualities of the experience with the films drawn from existing survey on microbicidal films, and general acceptability ratings drawn from market research methodology.
The purpose of the research is to compare the usual treatment approach (chemotherapy followed by surgery) to using chemotherapy followed by surgery and then more chemotherapy. This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. To decide if it is better, the study doctors will be looking to see if the study approach increases the lifespan of patients compared to the usual approach. There will be two arms of the study. Arm one will receive treatment with gemcitabine and capecitabine every 28 days for 6 cycles. Arm two be will receive standard of care observation. Participants will be asked to undergo imaging (e.g., CT) and laboratory testing to monitor for disease recurrence. The time in the study will be for 30 months.
OBJECTIVE: Epidemiologic evidence suggests that overweight persons who engage in modest amounts of physical activity - even that insufficient to produce or maintain weight loss - are at significantly reduced risk for health complications including all-cause mortality. Interventions for overweight persons targeting increased physical activity rather than weight loss as the main outcome of treatment have not been well studied and could represent simpler, more sustainable, and more cost-effective approaches in addressing the obesity epidemic.

METHOD: Pilot randomized controlled trial. Sedentary patients with BMI 25-45, and no major contraindications for unsupervised physical activity recruited. Participants randomized to receive either brief consultation consisting of 3 in-person meetings, a workbook, and limited telephone contact or usual care with their medical provider including access to community weight-loss groups/resources. Intervention therapists novice pre-professional students. The intervention is manualized and coded for treatment integrity. The main outcome measures are Cohen's d effect sizes and 95% confidence intervals for the change in moderate-equivalent intensity physical activity/week at 3 months relative to baseline assessed by a blinded assessor using the Stanford 7-Day Physical Activity Recall. Secondary outcomes include effect sizes and confidence intervals for changes in cardiorespiratory fitness and depression using the modified Canadian Aerobic Fitness test and Beck Depression Inventory. Analyses to be performed by intention to treat. Missing data to be imputed by baseline observation carried forward.
The safety and efficacy of valsartan and hydrochlorothiazide tablets as initial therapy for patients with severe hypertension (defined as a sitting diastolic blood pressure ≥ 110 mmHg and systolic blood pressure ≥ 140 mmHg off all antihypertensive therapy) were studied in a 6-week multicenter, randomized, double-blind study. Patients were randomized to either valsartan and hydrochlorothiazide (160/12.5 mg once daily) or to valsartan (160 mg once daily) and followed for blood pressure response. Patients were force-titrated at 2-week intervals. Patients on combination therapy were subsequently titrated to 160/25 mg followed by 320/25 mg valsartan/hydrochlorothiazide. Patients on monotherapy were subsequently titrated to 320 mg valsartan followed by a titration to 320 mg valsartan to maintain the blind. 

The study randomized 608 patients, including 261 (43%) females, 147 (24%) blacks, and 75 (12%) ≥ 65 years of age. The mean blood pressure at baseline for the total population was 168/112 mmHg. The mean age was 52 years. After 4 weeks of therapy, reductions in systolic and diastolic blood pressure were 9/5 mmHg greater in the group treated with valsartan and hydrochlorothiazide tablets compared to valsartan. Similar trends were seen when the patients were grouped according to gender, race, or age.
Chronic inflammation and dysregulated repair mechanisms after epithelial damage have been implicated in chronic obstructive pulmonary disease (COPD). However, the lack of ex vivo-models that accurately reflect multicellular lung tissue hinders our understanding of epithelial-mesenchymal interactions in COPD. Through a combination of transcriptomic and proteomic approaches applied to a sophisticated in vitro iPSC-alveolosphere with fibroblasts model, epithelial-mesenchymal crosstalk was explored in COPD and following SARS-CoV-2 infection. These experiments profiled dynamic changes at single-cell level of the SARS-CoV-2-infected alveolar niche that unveiled the complexity of aberrant inflammatory responses, mitochondrial dysfunction, and cell death in COPD, which provides deeper insights into the accentuated tissue damage/inflammation/remodeling observed in patients with SARS-CoV-2 infection. Importantly, this 3D system allowed for the evaluation of ACE2-neutralizing antibodies and confirmed the potency of this therapy to prevent SARS-CoV-2 infection in the alveolar niche. Thus, iPSC-alveolosphere cultured with fibroblasts provides a promising model to investigate disease-specific mechanisms and to develop novel therapeutics.
The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the studies described below with the incidence of anti-drug antibodies in other studies, including those of erenumab-aooe.

The immunogenicity of AIMOVIG has been evaluated using an immunoassay for the detection of binding anti-erenumab-aooe antibodies. For patients whose sera tested positive in the screening immunoassay, an in vitro biological assay was performed to detect neutralizing antibodies.

In controlled studies with AIMOVIG [see Clinical Studies (14)], the incidence of anti-erenumab-aooe antibody development was 6.2% (48/778) in patients receiving AIMOVIG 70 mg once monthly (2 of whom had in vitro neutralizing activity) and 2.6% (13/504) in patients receiving AIMOVIG 140 mg once monthly (none of whom had in vitro neutralizing activity). In a long-term study, including 12 weeks of double-blind treatment and up to 256 weeks of open-label treatment, the incidence of anti-erenumab-aooe antibody development was 11.1% (25/225) among patients whose AIMOVIG dose was 70 mg or 140 mg (2 of whom had in vitro neutralizing activity). The neutralizing anti-erenumab-aooe antibody positive rate may be underestimated because of limitations of the assay. Although these data do not demonstrate an impact of anti-erenumab-aooe antibody development on the efficacy or safety of AIMOVIG in these patients, the available data are too limited to make definitive conclusions.
Cancer cachexia is a progressive wasting syndrome, which is mainly characterized by systemic inflammatory response, weight loss, muscle atrophy, and fat loss. Paeoniflorin (Pae) is a natural compound extracted from the dried root of Paeonia lactiflora Pallas, which is featured in anti-inflammatory, antioxidant, and immunoregulatory pharmacological activities. While, the effects of Pae on cancer cachexia had not been reported before. In the present study, the effects of Pae on muscle atrophy in cancer cachexia were observed both in vitro and in vivo using C2C12 myotube atrophy cell model and C26 tumor-bearing cancer cachexia mice model. In the in vitro study, Pae could alleviate myotubes atrophy induced by conditioned medium of C26 colon cancer cells or LLC Lewis lung cancer cells by decreasing the expression of Atrogin-1 and inhibited the decrease of MHC and MyoD. In the in vivo study, Pae ameliorated weight loss and improved the decrease in cross-sectional area of muscle fibers and the impairment of muscle function in C26 tumor-bearing mice. The inhibition of TLR4/NF-κB pathway and the activation of AKT/mTOR pathway was observed both in C2C12 myotubes and C26 tumor-bearing mice treated by Pae, which might be the main basis of its ameliorating effects on muscle atrophy. In addition, Pae could inhibit the release of IL-6 from C26 tumor cells, which might also contribute to its ameliorating effects on muscle atrophy. Overall, Pae might be a promising candidate for the therapy of cancer cachexia.
Various embodiments provide a muscle testing device. In an example embodiment, the muscle testing device comprises a frame comprising a central frame element and two arms extending therefrom. The distance between the arms is adjustable. The muscle testing device further comprises a first sensing pad (a) configured to be secured to a first arm of the two arms, (b) configured to measure a force or pressure applied to a sensing surface thereof, and (c) being moveable between a first position and a second position. When the first sensing pad is secured to the first arm in the first position, the sensing surface faces a second arm of the two arms. When the first sensing pad is secured to the first arm in the second position, the sensing surface faces away from the second arm. The muscle testing device may be part of a muscle testing kit.
Deodorant compositions and a method of inhibiting bacterial exoenzymes responsible for the production of steroidal axillary malodor. The method comprises the steps of providing a cosmetic vehicle and dissolving or suspending a deodorant active material which is an inhibitor of bacterial exoenzymes responsible for the production of steroidal axillary malodor therein to produce a deodorant composition. Aryl sulfatase and beta-glucuronidase are the primary bacterial exoenzymes responsible for producing steroidal axillary odor. The deodorant active materials are inhibitors of these exoenzymes and include Cu++, hexametaphosphate (SPORIX), D-glucaro-▴-lactone, EDTA, NTA, O-phenanthroline, Sodium sulfate or orthophosphate. In an alternative embodiment of the invention, a cosmetic vehicle comprising inorganic acids, organic acids or water soluble metal salts of fatty acids is combined with a deodorant active material, selected from the group consisting of Zn++ compounds, which is an inhibitor of bacterial exoenzymes responsible for the production of steroidal axillary malodor. The deodorant active materials of the invention directly inhibit the bacterial exoenzymes responsible for the production of steroidal axillary malodor rather than neutralizing unpleasant odors through chemical interaction and indirect inhibition of bacterial growth. These materials may be dissolved or suspended in a cosmetic vehicle in the form of a soap, lotion, fluid, cream, gel stick, powder or spray to provide a deodorant composition to prevent axillary odor without disturbing the natural flora of the axilla.
An improved method is provided for the isolation of lymphocytes for use in the SCM test for the detection of cancer and other diseases and conditions. The method of the present invention can isolate either or both of the SCM-responding lymphocyte fractions from the same blood sample: the F2 fraction, with a buoyant density of 1.0590 g/cm3 to 1.0670 g/cm3 measured at 20 DEG  C. in a solution having an osmolality of about 0.315 Osm/kg, and the F4 fraction, with a buoyant density of 1.0690 g/cm3 to 1.0730 g/cm3. These lymphocyte fractions are isolated in visible bands and are substantially free of lymphocytes having other buoyant densities. This avoids cross-contamination of the lymphocyte fractions with each other as well as with SCM non-responding lymphocytes. Several gradients useful in this isolation method are described. This isolation method can use as starting material either a blood sample depleted of phagocytic cells or the total population of lymphocytes. The latter avoids the use of iron powder or carbonyl-iron powder in removing the phagocytic cells.
Proteinuria poses a substantial risk for the progression of chronic kidney disease (CKD) and its related complications. Kidneys excrete hundreds of individual proteins, some with a potential impact on CKD progression or as a marker of the disease. However, the available data on specific urinary proteins and their relationship with CKD severity remain limited. Therefore, we aimed to investigate the urinary proteome and its association with kidney function in CKD patients and healthy controls. The proteomic analysis of urine samples showed CKD stage-specific differences in the number of detected proteins and the exponentially modified protein abundance index for total protein (p = 0.007). Notably, specific urinary proteins such as B2MG, FETUA, VTDB, and AMBP exhibited robust negative associations with kidney function in CKD patients compared to controls. Also, A1AG2, CD44, CD59, CERU, KNG1, LV39, OSTP, RNAS1, SH3L3, and UROM proteins showed positive associations with kidney function in the entire cohort, while LV39, A1BG, and CERU consistently displayed positive associations in patients compared to controls. This study suggests that specific urinary proteins, which were found to be negatively or positively associated with the kidney function of CKD patients, can serve as markers of dysfunctional or functional kidneys, respectively.
* Chlorhexidine group: Oral hygiene will be carried out in accordance with the standard operating procedures already carried out for all patients admitted to the ICU. First, the secretion contained in the oral cavity will be aspirated with a suction probe or a dental sucker or the suction brush itself before starting the oral hygiene procedure. The hygiene process will begin by moistening the oral cavity, using non-sterile gauze soaked in filtered mineral water and applying it to the entire oral mucosa. Subsequently, the sucking toothbrush or oral swab should be moistened frequently with 0.12% chlorhexidine digluconate solution and proceed with cleaning the dental surfaces on their buccal, palatal and occlusal surfaces, moving towards the oral cavity and tongue, using the bristle part of the toothbrush; With the region opposite the dental bristles or oral swab, the 0.12% chlorhexidine solution will be applied to the oral mucosa, palate, tongue dorsum and orotracheal tube, always performing a postero-anterior movement and removing any dirt with the aid of moistened gauze . The oral cavity will be constantly vacuumed throughout the oral hygiene procedure. Finally, the lips will be lubricated with a standardized lip moisturizer. The procedure will be carried out every 8 hours, that is, three times a day.
* Water group: The intervention group procedure will be carried out in the same way and frequency as the control group, however, replacing the 0.12% chlorhexidine solution with mineral water. Oral hygiene will be carried out by the nursing team, who will be blind to the indices to be evaluated. The team will be previously trained to carry out hygiene procedures by the ICU team of dental surgeons.
Risk Summary

Based on findings from animal studies and its mechanism of action [see Clinical Pharmacology (12.1)], OFEV can cause fetal harm when administered to a pregnant woman. There are no data on the use of OFEV during pregnancy. In animal studies of pregnant rats and rabbits treated during organogenesis, nintedanib caused embryo-fetal deaths and structural abnormalities at less than (rats) and approximately 5 times (rabbits) the maximum recommended human dose [see Data]. Advise pregnant women of the potential risk to a fetus.

The estimated 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 is 2% to 4% and miscarriage in clinically recognized pregnancies is 15% to 20%.

Data

Animal Data

In animal reproduction toxicity studies, nintedanib caused embryo-fetal deaths and structural abnormalities in rats and rabbits at less than and approximately 5 times the maximum recommended human dose (MRHD) in adults (on a plasma AUC basis at maternal oral doses of 2.5 and 15 mg/kg/day in rats and rabbits, respectively). Malformations included abnormalities in the vasculature, urogenital, and skeletal systems. Vasculature anomalies included missing or additional major blood vessels. Skeletal anomalies included abnormalities in the thoracic, lumbar, and caudal vertebrae (e.g., hemivertebra, missing, or asymmetrically ossified), ribs (bifid or fused), and sternebrae (fused, split, or unilaterally ossified). In some fetuses, organs in the urogenital system were missing. In rabbits, a significant change in sex ratio was observed in fetuses (female:male ratio of approximately 71%:29%) at approximately 15 times the MRHD in adults (on an AUC basis at a maternal oral dose of 60 mg/kg/day). Nintedanib decreased post-natal viability of rat pups during the first 4 post-natal days when dams were exposed to less than the MRHD (on an AUC basis at a maternal oral dose of 10 mg/kg/day).
BACKGROUND: Haemorrhage is a leading cause of preventable mortality in high-income countries and emergency management presents unique challenges in the prehospital setting. The study aimed to determine incidence and characteristics of fatalities from prehospital haemorrhage in Sweden.
METHODS: A nationwide retrospective cohort study 2012-2021 was conducted using data from the Swedish National Board of Health and Welfare. Prehospital fatality from haemorrhage was defined as a cause of death related to haemorrhage (Appendix 1) without a hospital admission on the same day. Primary outcome was age-standardized mortality rate per 100,000 inhabitants.
RESULTS: A total of 9801 prehospital fatalities from haemorrhage were identified. Annual age-standardized mortality rate decreased from 10.97 to 8.18 per 100,000 population (coefficient =  - 0.28, r2 = 0.85, p =  < 0.001). Trauma was the most common cause (3512, 35.83%) with intentional self-harm (X60-X84), transport accidents (V01-V99) and assault (X85-Y09) being the most common mechanisms of injury. Traumatic fatalities were younger and a larger proportion were male compared to non-traumatic causes (p < 0.001). Overall median Charlson Comorbidity Index (Quan) was 0 [0-2] with a lower index noted for traumatic causes (p < 0.001). Trauma resulted in a median of 26.1 [3.65-49.22] years of life lost per patient compared to 0 [0-3.65] for non-traumatic causes (p < 0.001). Regional variations in mortality rate were observed with lower population density correlating with higher mortality rate (ρ =  - 0.64, p = 0.002).
CONCLUSIONS: Prehospital mortality from haemorrhage decreased between 2012 and 2021. Trauma was the most common cause which resulted in many years of life lost in a population with a low burden of comorbidities. There were considerable regional differences with low population density associated with higher mortality rate from prehospital haemorrhage.
For the focus group, the participant will be asked to review the potential platform the investigators are developing to better describe risks of health are developing to better describe risks of health issues in childhood cancer survivors. The focus group session will last approximately 2 hours.