anthonyyazdaniml/gliner-biomed-curated-corpus huggingface dataset:
SNRIs, including FETZIMA, have been associated with increases in blood pressure. Blood pressure should be measured prior to initiating treatment and periodically throughout FETZIMA treatment. Pre-existing hypertension should be controlled before initiating treatment with FETZIMA. Caution should be exercised in treating patients with pre-existing hypertension, cardiovascular, or cerebrovascular conditions that might be compromised by increases in blood pressure. For patients who experience a sustained increase in blood pressure while receiving FETZIMA, discontinuation or other appropriate medical intervention should be considered.

Table 2 shows the mean changes in blood pressure, sustained hypertension, and upward shifts in hypertensive status that were observed in FETZIMA-treated adult patients in the short-term placebo-controlled studies. 

In the short-term, placebo-controlled MDD studies in adults, the mean increase from initiation of treatment in systolic BP was 3 mm Hg and diastolic BP was 3.2 mm Hg, as compared to no change in the placebo group. There were no dose-related changes in systolic and diastolic blood pressure observed. 

In adult patients exposed to one-year, open-label treatment of FETZIMA (doses range from 40-120 mg once daily), the mean change from initiation of treatment in systolic BP was 3.9 mm Hg and diastolic BP was 3.1 mm Hg. 

In short-term, placebo- and active-controlled MDD studies in pediatric patients 7 years to less than 18 years of age, treatment with FETZIMA was associated with the occurrence of new-onset hypertension (two systolic and/or diastolic BP measurements in the stage I hypertension range and/or one measurement in the stage II range) in 36.2% of treated patients compared with 20.7% of patients randomized to placebo. Elevations in either systolic or diastolic BP leading to measures at or above the stage II hypertension threshold occurred in 12.1% of pediatric patients treated with FETZIMA and 7.5% of patients randomized to placebo. Sustained hypertension (three or more consecutive systolic or diastolic BP measurements at or above the stage I hypertension threshold) occurred in 15% of pediatric patients treated with FETZIMA and 4% of patients randomized to placebo. The safety and effectiveness of FETZIMA have not been established in pediatric patients for the treatment of MDD. 

In the short-term, placebo-controlled studies in adults, 11.6% of patients met orthostatic hypotension criteria (SBP or DBP) in the FETZIMA group compared to 9.7% in the placebo group. Orthostatic reductions of blood pressure ≥ 10 mm Hg in DBP occurred in 5.8%, 6.1%, and 9.8% of FETZIMA-treated patients with doses of 40, 80, and 120 mg/day respectively, compared to 6.2% of placebo-treated patients.

Concomitant use of FETZIMA with drugs that increase blood pressure and heart rate has not been evaluated and such combinations should be used with caution. Effects of FETZIMA on blood pressure in patients with significant hypertension or cardiac disease have not been systematically evaluated. FETZIMA should be used with caution in these patients.
Plaque psoriasis vulgaris is a chronic inflammatory skin disorder. There are 2 key abnormalities in psoriasis, hyper proliferation of keratinocytes and an inflammatory cell infiltrate, which includes; dendritic cells (DCs), macrophages, natural killer (NK) T cells, mast cells, T cells and neutrophils. There is strong evidence that T cells have an important role in psoriasis, including the fact that T-cell targeted agents are effective in psoriasis therapy. This study is the first time AZD0284 will be given to humans. The current Phase 1 study investigates the safety, tolerability, food effect, pharmacokinetic (PK) and pharmacodynamic (PD) properties of single and repeated doses of AZD0284. The study will be conducted in healthy subjects to avoid interference from disease processes or other drugs. The study will be divided into 2 parts: Part 1 (SAD) and Part 2 (MAD), with Part 1 being split into 2 sub-parts: 1A (fasting) and 1B (fed). The secondary and safety pharmacology of AZD0284 has been investigated using both in vitro and in vivo models. Screening of AZD0284 in a diverse set of in vitro radiolig and binding, enzyme, functional and electrophysiological assays including cardiac ion channels did not identify any off-target activities likely to be relevant in or near the therapeutic exposure range. The inclusion and exclusion criteria are defined such that the selected subjects will be free of any significant illness when included in the study. The selected starting dose for the SAD part (Part 1A) of the study is 4.0 mg AZD0284 (oral solution). The maximum allowed exposure based on the toxicology studies is 127 μmol\*h/L (total AUC(0-24,ss)) or 7.35 μmol/L (total Cmax). In Part 1A (SAD study), 6 dose levels and in Part 2 (MAD study), 3 dose levels are planned. In either part, up to 2 additional doses may be added if needed. The results from this study will form the basis for decisions on future studies. The study will help to identify appropriate, well-tolerated doses that can be administered in subsequent studies in patients with psoriasis.
OBJECTIVE: Patients with impaired kidney function and increased albuminuria are at risk of developing cardiovascular disease (CVD). Previous research has revealed that a substantial proportion of patients with chronic kidney disease (CKD) do not get a registered diagnosis in the electronic health record of the general practitioner. The aim of this study was to investigate the association between non-registration of CKD and all-cause mortality and cardiovascular outcome.
DESIGN AND SETTING: A retrospective study in primary care.
METHODS: The analyses were carried out in the INTEGO database, a general practice-based morbidity registration network in Flanders, Belgium. The study used INTEGO data from the year 2018 for all patients ≥18 years old, including 10 551 patients. To assess the risk of mortality and CVD, a time-to-event analysis was performed. Cox proportional hazard model was used to evaluate the association between non-registration and incidence of all-cause mortality and cardiovascular events with mortality as a competing risk. Subgroup analyses were performed for estimated glomerular filtration rate stages (3A, 3B, 4 and 5). Multiple imputation was done following the methodology of Mamouris et al. RESULTS: Mortality was higher in patients with non-registered CKD compared with patients with registered CKD (HR 1.29, 95% CI 1.19 to 1.41). Non-registration of CKD was not associated with an increased risk for the development of CVD (HR 0.92, 95% CI 0.77 to 1.11).
CONCLUSION: An association between non-registration and all-cause mortality was identified, although no such association was apparent for CVD.
Exposure and Response Prevention (ERP) therapy has become the treatment of choice for specific phobias. ERP involves systematic and repeated exposure to a feared or anxiety-provoking stimulus, leading to habituation and extinction of the fear response. Animal models of fear extinction have shown that acute administration of D-cycloserine (DCS) prior to exposure to a feared stimulus enhances extinction of that fear. A recent study in human subjects with height phobia (a specific phobia) has also demonstrated that DCS facilitates the effects of ERP therapy. Current theories postulate that DCS facilitates fear extinction by enhancing the learning process and increasing consolidation of memories, but the neural mechanisms underlying this process are not understood. The proposed research aims to elucidate these mechanisms by using fMRI to measure brain activation during 1) symptom provocation and verbal learning two hours post-medication, and 2)repeated symptom provocation and verbal recognition one week post-medication. This research will also examine the effects of DCS on cognitive functioning using neuropsychological testing both two house and one week post-medication.
Patients would be treated with IVIg 400mg/kg per day for 5 days monthly. And treatment discontinued when platelet counts exceeded 100 × 10\^9/L.
BACKGROUND: In lung transplant, the United Network for Organ Sharing (UNOS) contains a diagnosis of secondary pulmonary hypertension (SPH). SPH and pulmonary arterial hypertension are treated the same in the allocation scoring system. It is not clear whether utilizing the SPH diagnosis instead of the primary diagnosis is helpful to patients or providers.
METHODS: Analysis of UNOS data from May 2005 through July 2021, comparing patients listed under the SPH diagnosis with patients listed under COPD and interstitial lung disease (ILD) who met criteria for PH (COPD-PH and ILD-PH, respectively), as well as patients listed under pulmonary arterial hypertension (primary pulmonary hypertension, PPH). Competing-risk analysis examined waitlist and post-transplant outcomes. An exploratory analysis of UNOS spirometry data was performed.
RESULTS: Compared to patients listed under the SPH diagnosis, patients with ILD-PH were more likely to undergo transplantation (adjusted HR: 1.34, 95% confidence interval: 1.16-1.54, P < .001), with no significant difference comparing the SPH diagnosis to PPH or to COPD-PH. Waitlist mortality did not vary between groups. Post-transplant survival was lower in patients with PPH (adjusted HR: 1.35, 95% confidence interval: 1.04-1.75, P = .025), with no significant difference comparing the SPH diagnosis to COPD-PH or ILD-PH. Spirometry failed to demonstrate a clear phenotype within the SPH diagnosis.
CONCLUSION: In an adjusted analysis, patients with advanced lung disease and secondary PH were more likely to undergo transplantation when listed for ILD than when listed under the SPH diagnosis. The SPH diagnosis is too clinically heterogeneous to be useful in predictive models and should be considered for removal from UNOS.
INTRODUCTION: We present a case of late endograft infection that progressed to the left iliac and femoral arteries, leading to left lower extremity gangrene, and the patient's death.
CASE: A 65-year-old male with a history of endovascular abdominal aortic aneurysm repair (EVAR) developed left acute limb ischemia (Rutherford category III) and abdominal pain. A CT scan showed significant gas formation around the endograft and complete occlusion of the left distal iliac artery to the femoral arteries. Despite undergoing hip disarticulation and wound care, aortic endograft removal was not possible due to a lack of replacement grafts. Microbiological cultures from arterial pus and urine identified multiple antibiotic-resistant extended-spectrum beta-lactamases (ESBL) producing Escherichia coli. Histopathological analysis of the common femoral artery specimen indicated chronic medium-sized arteritis characterized by endothelial erosion, fibrotic myocytes in the tunica media, and fibrosis of the adventitial layer with inflammatory cell infiltration. The patient succumbed in the ICU 6 days later due to uncontrolled sepsis.
DISCUSSION: Although the incidence of endograft infection after EVAR is low (20-75% morbidity and mortality), it poses significant risks. Sources are often hematogenous, stemming from urinary or respiratory tract infections, and infections extending to subsequent arteries are very rare; they could cause chronic arterial inflammation and, in the long term, may lead to thrombosis and limb ischemia. This case highlights a low-grade infection that emerged 3 months post-procedure. Diagnosis typically involves CT angiography to detect periaortic gas or fluid. Management of high-grade infections necessitates complete endograft removal and graft replacement with infection-resistant options.
CONCLUSION: Endograft infections after EVAR, while rare, can have severe outcomes. Early diagnosis based on symptoms and CT-Scan. In high-grade infections, endograft removal is the gold-standard therapy, with ongoing follow-up post-EVAR being essential for prevention.
Substantial research on complete Achilles tendon ruptures is available, but guidance on partial ruptures is comparatively sparse. Conservative management is considered acceptable in partial tendon ruptures affecting less than 50% of the tendon's width, but supporting experimental evidence is currently lacking. Using a previously validated finite element model of the Achilles tendon, this study aimed to assess whether loading conditions simulating an early functional rehabilitation protocol could elicit progression to a complete rupture in partial ruptures of varying severity. In silico tendon rupture simulations were performed to locate the most likely rupture site for least, moderate, and extreme subtendon twist configurations. These three models were split at the corresponding rupture site and two sets of partial ruptures were created for each, starting from the medial and lateral sides, and ranging from 10% to 50% loss of continuity. Simulations were conducted with material parameters from healthy and tendinopathic tendons. Partial ruptures were considered to progress if the volume of elements showing a maximum principal strain above 10% exceeded 3 mm3. To assess whether the tendinopathic tendons typical geometric characteristics could compensate for the inferior material properties found in tendinopathy, an additional model with increased cross-sectional area in the free tendon region was developed. Progression to complete ruptures occurred even with less than a 50% loss of continuity, regardless of subtendon twisting, and material parameters. The tendinopathic tendon model with increased cross-sectional area showed similar results. These findings suggest the current criteria for surgical treatment of partial ruptures should be reconsidered. Statement of clinical significance: The clinical significance and most appropriate treatment of partial ruptures of the Achilles tendon is unclear. Despite the widespread use of the "50% rule" in treatment decisions of partial tendon ruptures, experimental evidence supporting it is missing. The present study provides new data, from a validated aponeurotic and free Achilles tendon finite element model, showing that partial ruptures may progress to complete ruptures under loading conditions elicited from functional rehabilitation protocols, even for partial ruptures affecting less than 50% of the tendon's width. Under these novel findings, the current criteria for surgical treatment of partial ruptures should be reconsidered.
The packaging is for toothpaste and/or other products for oral hygiene. A portion of toothpaste (2) may be enclosed in a capsule (1) which may be opened by chewing or by dissolving in the mouth. The complete capsules may be sold in a set of blister packs (3) which are easy to open. The individual packs (4) are separated from one another by perforated lines (5) to enable them to be easily detached. The complete pack (3) may incorporate blister packs containing a variety of different products (6,7,8). USE/ADVANTAGE - Blister pack containing oral hygiene products eg. toothpaste in capsule form.
Orthognathic surgery typically relies on the rigid fixation of fracture fragments using metal hardware. Though hardware is usually intended to be implanted permanently, the removal of hardware (ROH) is sometimes indicated for a variety of reasons. The authors sought to identify risk factors for ROH following orthognathic surgery. The authors conducted a retrospective analysis of the Merative MarketScan Research Databases, 2007-2021 using Current Procedural Terminology (CPT) and International Classification of Disease (ICD-9 and ICD-10) codes to identify patients who underwent an index Le Fort 1 osteotomy and bilateral sagittal split osteotomy operation on the same day. Statistical analysis involved χ 2 , Shapiro-Wilk, Wilcoxon-Mann-Whitney, Poisson regression, and multivariable logistic regression tests. 4698 patients met the inclusion criteria. The mean age at surgery was 25 years, and 57% were female. ROH occurred in 5.9% of patients. The mean time to hardware removal was 190.5±172.4 days. In a multivariate logistic regression, increased odds of ROH were associated with older patient age [OR: 1.02 (1.01-1.03), P =0.046], sleep apnea [OR: 1.62 (1.13-2.32), P =0.018], and craniofacial syndrome and/or cleft diagnoses [OR: 1.88 (1.14-2.55), P <0.001]. In the same model, postoperative oral antibiotic prophylaxis was not associated with ROH ( P =0.494). The incidence of all-cause complications [IRR: 1.03 (1.01-1.05), P <0.001] rose over the study period, while the incidence of ROH did not change significantly ( P =0.281). Patients at elevated risk should be counseled on the increased possibility of a second operation for ROH before having orthognathic surgery to ensure expectations and health care utilization decisions align with the evidence.
Neural oscillations align their phase to the rhythm of speech. This phenomenon is termed neural entrainment and associated with successful speech comprehension. Importantly, we have demonstrated that transcranial alternating current stimulation (tACS) can be used to manipulate how neural activity aligns to speech rhythm, leading to changes in speech perception. The aim of Experiment 1 is to understand how tACS operates on the neural level. This aim will be reached by testing whether tACS produces rhythmic electroencephalography (EEG) responses that outlast the stimulation, indicating an involvement of endogenous oscillatory activity. The aim of Experiment 2 is to increase efficacy of tACS and, consequently, its potential to play an important role in research and everyday life applications. This aim will be reached by using brain imaging (fMRI) to predict optimal stimulation protocols for individual participants. The aim of Experiment 3 is to reveal how tACS can boost speech perception in a multi-speaker scenario. This aim will be reached by using tACS to enhance attended speech or suppress distracting speech, and by comparing these two approaches in their efficacy to boost speech perception. The aim of Experiment 4 is to combine established techniques to create novel opportunities to improve speech perception. This aim will be reached by using neurofeedback to teach participants to enhance their own neural entrainment, applying tACS to support them in this process.
PROBLEM TO BE SOLVED: To provide a method for activating cell-mediated immunity(CMI) by heat treating blood without imparting physical denaturation to the blood cells and an apparatus therefor. SOLUTION: This method comprises activating the CMI of lymphocytes, etc. by heating the blood of a living body to 38 to 41 deg.C by a heat source of 55 to 80 deg.C. This device for activating the CMI by the heat treatment of the blood is provided with a blood pipeline 1 which takes the blood out of the living body and a heating mechanism 3 for heating the blood in a range of 55 to 80 deg.C and a blood delivery pump 2 for regulating the flow rate of the blood so that the blood is heated in a range of 38 to 41 deg.C heating temp. in correspondence to the heating temp. of this heating mechanism 3 in the middle of this blood pipeline 1.
The invention is directed to a method for sterilizng a pharmaceutical formulation comprising a suspension of a water-insoluble pharmaceutical, comprising the steps of heat-sterilizing an aqueous solution of a viscosity enhancer, to result in a first sterile premix. Next is sterile-filtering an aqueous solution of a mixture of a pharmaceutically-active compound, which results in a second sterile pre-mix. Next is heat-sterilizing a mixture of water, a water-insoluble pharmaceutical, and at least a partial amount of an electrolyte to provide a sub-saturated solution of the electrolyte, and adding under aseptic conditions an aqueous surfactant, to give a third sterile pre-mix. Finally, combining all three pre-mixes in sterile fashion to achieve a sterile suspended pharmaceutical formulation. Thus, for the third pre-mix, use of either Sodium chloride (in varying proportion) or Sodium acetate (in one proportion, but not limited to) is given as an example. The invention is also directed to methods for making sterile suspensions of pharmaceutically active compositions including Ciprofloxacin and hydrocortisone, and pharmaceutical compositions made according to this process.
Mechanical Bowel Preparation + oral antibiotics group: receiving mechanical bowel preparation only MBP will be prepared with 4 liters of Polyethylene glycol (PEG) solution to be started 24 hours before the planned surgery. 500mg of Metronidazole will be administrated 3 times one day before the surgery at 2 pm, 3 pm and 10 pm.
Women in age 35 to 65 with suspected breast cancer, previously untreated. Additionally, eligible patients should have appropriate mammography results, either breast ultrasound or breast MRI.
Recent adult clinical trials involving combination HAART, including a protease inhibitor (PI), have demonstrated improvements in somatic immune system functioning. \[AS PER AMENDMENT 2/27/01: More recently, similar success has been demonstrated with a PI-sparing regimen, zidovudine, lamivudine, and efavirenz.\] Not all individuals, however, experience the same level of immune reconstitution, and oftentimes any improvement is short-lived. Adolescent patients may have a greater potential for immune restoration because of residual thymic tissue and therefore may experience greater long-term virus-free states as compared to adult patients. This study examines the duration of virologic efficacy HAART has on the adolescent HIV-positive population.

Patients begin study by initiating a HAART regimen of a minimum of 3 drugs, at least 1 of which must be a PI \[AS PER AMENDMENT 2/27/01: or efavirenz (EFV)\]. A variety of drug combinations are used; therefore, patients are grouped according to the classes of drugs in their respective regimen (e.g., 2 nucleoside reverse transcriptase inhibitors \[NRTIs\] plus 1 PI; 2 NRTIs plus 2 PIs; 1 or 2 NRTIs plus 1 PI plus 1 nonnucleoside reverse transcriptase inhibitor \[NNRTI\] \[AS PER AMENDMENT 2/27/01: ; and 2 NRTIs plus EFV\]). At the time of HAART initiation, patients undergo immunologic and virologic assessments in order to determine baseline values. Then, to determine the virologic success or failure of HAART, HIV-1 RNA measurements are taken and compared to initial baseline values. Virologic success equals undetectable HIV-1 RNA at Week 12 \[AS PER AMENDMENT 2/27/01: and confirmed at Week 16\] or a significant (greater than 1 log) decrease in HIV-1 RNA from baseline to Week 12 \[AS PER AMENDMENT 2/27/01: and confirmed undetectable HIV-1 RNA before the next scheduled visit (Week 24)\]. Patients are followed for a minimum of 3 years of maintained viral suppression or until they have demonstrated virologic failure. From these values, any correlation that may exist between HIV-1 RNA values and HAART can be deduced. Patients with virologic failure on the initial HAART regimen may be allowed to change to a second HAART regimen. \[AS PER AMENDMENT 2/27/01: Patients with virologic success on the second HAART regimen are followed for a minimum of 3 years.\] Patients with virologic failure on the second HAART regimen or who voluntarily discontinue HAART are followed using an abbreviated schedule for 3 years.