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

Based on its mechanism of action COLUMVI may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)]. There are no available data on the use of COLUMVI in pregnant women to evaluate for a drug-associated risk. No animal reproductive and developmental toxicity studies have been conducted with glofitamab-gxbm. 

Glofitamab-gxbm causes T-cell activation and cytokine release; immune activation may compromise pregnancy maintenance. In addition, based on expression of CD20 on B cells and the finding of B-cell depletion in non-pregnant animals, glofitamab-gxbm can cause B-cell lymphocytopenia in infants exposed to glofitamab-gxbm in utero. Human immunoglobulin G (IgG) is known to cross the placenta; therefore, COLUMVI has the potential to be transmitted from the mother to the developing fetus. Advise women of the potential risk to the fetus.

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.
PURPOSE: This study investigated the effects of the SPEAK OUT! & LOUD Crowd therapy program on speaking rate, percent pause time, intelligibility, naturalness, and communicative participation in individuals with Parkinson's disease (PD).
METHOD: Six adults with PD completed 12 individual SPEAK OUT! sessions across four consecutive weeks followed by group-based LOUD Crowd sessions for five consecutive weeks. Most therapy sessions were conducted via telehealth, with two participants completing the SPEAK OUT! portion in person. Speech samples were recorded at six time points: three baseline time points prior to SPEAK OUT!, two post-SPEAK OUT! time points, and one post-LOUD Crowd time point. Acoustic measures of speaking rate and percent pause time and listener ratings of speech intelligibility and naturalness were obtained for each time point. Participant self-ratings of communicative participation were also collected at pre- and posttreatment time points.
RESULTS: Results showed significant improvement in communicative participation scores at a group level following completion of the SPEAK OUT! & LOUD Crowd treatment program. Two participants showed a significant decrease in speaking rate and increase in percent pause time following treatment. Changes in intelligibility and naturalness were not statistically significant.
CONCLUSIONS: These findings provide preliminary support for the effectiveness of the SPEAK OUT! & LOUD Crowd treatment program in improving communicative participation for people with mild-to-moderate hypokinetic dysarthria secondary to PD. This study is also the first to demonstrate positive effects of this treatment program for people receiving the therapy via telehealth.
Safety and effectiveness in the pediatric population have not been established (see BOX WARNING and WARNINGS, Clinical Worsening and Suicide Risk). Three placebo-controlled trials in 752 pediatric patients with MDD have been conducted with paroxetine hydrochloride, and the data were not sufficient to support a claim for use in pediatric patients. Anyone considering the use of paroxetine tablets in a child or adolescent must balance the potential risks with the clinical need. Decreased appetite and weight loss have been observed in association with the use of SSRIs. Consequently, regular monitoring of weight and growth should be performed in children and adolescents treated with an SSRI such as paroxetine tablets. 

In placebo-controlled clinical trials conducted with pediatric patients, the following adverse events were reported in at least 2% of pediatric patients treated with paroxetine hydrochloride and occurred at a rate at least twice that for pediatric patients receiving placebo: emotional lability (including self-harm, suicidal thoughts, attempted suicide, crying, and mood fluctuations), hostility, decreased appetite, tremor, sweating, hyperkinesia, and agitation.

Events reported upon discontinuation of treatment with paroxetine in the pediatric clinical trials that included a taper phase regimen, which occurred in at least 2% of patients who received paroxetine hydrochloride and which occurred at a rate at least twice that of placebo, were: emotional lability (including suicidal ideation, suicide attempt, mood changes, and tearfulness), nervousness, dizziness, nausea, and abdominal pain (see DOSAGE AND ADMINISTRATION, Discontinuation of Treatment With Paroxetine Tablets).
Camrelizumab: 200mg,d1,15,29,43,57,I.V oxaliplatin：65mg/m2，d1，8，22, 29 capecitabine: 625mg/m2, bid d1-5; q1w, po,6 weeks in total. radiotherapy： 50-50.4Gy ，1.8-2 Gy/d，5d/w.
PROBLEM TO BE SOLVED: To obtain an antiallergic agent useful for treating various allergic diseases such as bronchial asthma, atopic dermatitis and allergic rhinitis, and providing a little side effect by making the agent include a hydrophilic solvent extract of a mushroom. SOLUTION: This antiallergic agent contains a hydrophilic solvent extract of a mushroom. To obtain the hydrophilic solvent extract of the mushroom, selection of a grown mushroom is desirable, and the whole fruit body can be used but especially stem and ferrule parts are effective. The extraction of an effective component from the mushroom fruit body is preferably carried out by slicing the fruit body in a fresh state without browning or the one obtained by freezing the fruit body in the state, and rapidly inserting the sliced fruit body into a hot extraction solvent. The extraction solvent is preferably water, ethanol or a mixed solvent of the water and the ethanol. The daily dose is generally 0.01-50 g, especially 0.1-5 g.
Part A will investigate EP395 as a 'victim' of DDIs. The impact of CYP3A4 and P-glycoprotein (Pgp) inhibition on the pharmacokinetics (PK) of EP395 will be assessed. Verapamil has been selected as a moderate inhibitor of CYP3A4 and an inhibitor of Pgp.
The 12-lead electrocardiogram (ECG) is widely used for diagnosing cardiovascular diseases in clinical practice. Recently, deep learning methods have become increasingly effective for automatically classifying ECG signals. However, most current research simply combines the 12-lead ECG signals into a matrix without fully considering the intrinsic relationships between the leads and the heart's structure. To better utilize medical domain knowledge, we propose a multi-branch network for multi-label ECG classification and introduce an intuitive and effective lead grouping strategy. Correspondingly, we design multi-branch networks where each branch employs a multi-scale convolutional network structure to extract more comprehensive features, with each branch corresponding to a lead combination. To better integrate features from different leads, we propose a feature weighting fusion module. We evaluate our method on the PTB-XL dataset for classifying 4 arrhythmia types and normal rhythm, and on the China Physiological Signal Challenge 2018 (CPSC2018) database for classifying 8 arrhythmia types and normal rhythm. Experimental results on multiple multi-label datasets demonstrate that our proposed multi-branch network outperforms state-of-the-art networks in multi-label classification tasks.
Reactivation or primary infection with double-stranded DNA viruses is common in recipients of solid organ transplants (SOTs) and is associated with significant morbidity and mortality. Treatment with conventional antiviral medications is limited by toxicities, resistance, and a lack of effective options for adenovirus (ADV) and BK polyomavirus (BKPyV). Virus-specific T cells (VSTs) have been shown to be an effective treatment for infections with ADV, BKPyV, cytomegalovirus (CMV), and Epstein-Barr virus (EBV). Most of these studies have been conducted in stem cell recipients, and no large studies have been published in the SOT population to date. In this study, we report on the outcome of quadrivalent third-party VST infusions in 98 recipients of SOTs in the context of an open-label phase 2 trial. The 98 patients received a total of 181 infusions, with a median of 2 infusions per patient. The overall response rate was 45% for BKPyV, 65% for cytomegalovirus, 68% for ADV, and 61% for Epstein-Barr virus. Twenty percent of patients with posttransplant lymphoproliferative disorder had a complete response and 40% of patients had a partial response. All the VST infusions were well tolerated. We conclude that VSTs are safe and effective in the treatment of viral infections in SOT recipients.
BACKGROUND: Atrial fibrillation (AF) in patients resuscitated from cardiac arrest (CA) is associated with increased short-term mortality. However, whether this is because AF adversely affects early resuscitation success, causes post-resuscitation morbidity, or because it is a marker for patient co-morbidities, remains unclear. We aimed to determine the prevalence of AF in patients with ROSC to test the hypothesis that AF is associated with increased risk of rearrest and to determine its impact on mortality and stroke risk.
METHODS: We performed a retrospective study of emergency medical services patients with OHCA and ROSC. To examine long-term morbidity and mortality due to AF, an additional observational cohort analysis was performed using a large electronic health record (EHR) database.
RESULTS: One hundred nineteen patients with ROSC prior to ED arrival were identified. AF was observed in 39 (33%) of patients. Rearrest was not different between AF and no AF groups (44% vs. 41%, p = 0.94). In the EHR analysis, mortality at one year in patients who developed AF was 59% vs. 39% in no AF patients. Odds of stroke was 5x greater in AF patients (p < 0.001), with the majority not anticoagulated (93%, p < 0.001) and comorbidities were greater p < 0.001).
CONCLUSIONS: AF was common following ROSC and not associated with rearrest. AF after CA was associated with increased mortality and stroke risk. These data suggest rhythm control for AF in the immediate post-ROSC period is not warranted; however, vigilance is required for patients who develop persistent AF, particularly with regards to stroke risk and prevention.
OBJECTIVE: Ovarian torsion (OT) represents a severe gynecological emergency in female pediatric patients, necessitating immediate surgical intervention to prevent ovarian ischemia and preserve fertility. Prompt diagnosis is, therefore, paramount. This retrospective study set out to assess the utility of combined clinical, ultrasound, and laboratory features in diagnosing OT.
METHODS: The authors included 326 female pediatric patients aged under 14 years who underwent surgical confirmation of OT over a five-year period. Logistic regression analysis was employed to pinpoint factors linked with OT, and the authors compared clinical presentation, laboratory results, and ultrasound characteristics between patients with OT (OT group) and without OT (N-OT group). The authors conducted receiver operating characteristic (ROC) curve analysis to gauge the predictive capacity of the combined features.
RESULTS: Among 326, OT was confirmed in 24.23 % (79 cases) of the patients. The OT group had a higher incidence of prenatal ovarian masses than the N-OT (22 cases versus 7 cases) (p < 0.0001). Similarly, the authors observed significant differences in the presence of lower abdominal pain, suspected torsion on transabdominal ultrasound, and a high neutrophil-lymphocyte ratio (NLR > 3) between the OT and non-OT groups (p ˂ 0.05). Furthermore, when these parameters were combined, the resulting area under the curve (AUC) was 0.868, demonstrating their potential utility in OT diagnosis.
CONCLUSION: This study demonstrates a prediction model integrating clinical, laboratory, and ultrasound findings that can support the preoperative diagnosis of ovarian torsion, thereby enhancing diagnostic precision and improving patient management. Future prospective studies should concentrate on developing clinical predictive models for OT in pediatric patients.
Peritoneal dialysis (PD) patients who undergo gastroendoscopy and colonoscopy are at increased risk of peritoneal dialysis-associated peritonitis (PD peritonitis) following the procedure (defined as occurring within 7 days of intervention). As per current International Society for PD (ISPD) guidelines, antibiotic prophylaxis is currently recommended pre-colonoscopy in PD patients given the risk of post-colonoscopy PD peritonitis. The risk of PD peritonitis in patients undergoing capsule endoscopy (CE) is unknown. This binational data-linkage study between the Australia and New Zealand Dialysis and Transplant Registry and all hospital admission data sets in Australia and New Zealand evaluated all patients with PD who underwent CE between 2006 and 2015. The objective of the study was to assess the risk of PD peritonitis in patients undergoing CE. Descriptive statistics were used to describe patient characteristics and clinical outcomes. Overall, 23 patients with PD underwent CE. Twelve patients underwent CE alone (i.e. no other concomitant procedures) and none of these patients experienced an episode of PD peritonitis. The remaining 11 patients underwent CE and other invasive endoscopic/abdominal surgical procedures, of whom 2 suffered PD peritonitis. CE is likely a relatively safe procedure in PD patients. PD patients undergoing CE may not require prior antibiotic prophylaxis. Given their relative safety, CE may be an appealing diagnostic tool in a select group of PD patients for the investigation of gastrointestinal disease.
CKD is based on estimated GFR calculated by the MDRD method of \< 60 mL/min/1.73m\^2. Anemia is defined as Hemogloblin \<12 g/dL in women, \< 13 g/dL in men per WHO criteria. Participants completed the study at Week 2 and completed an anemia work-up; data contributed to prevalence estimates.
Small animal studies in biomedical research often require anesthesia to reduce pain or stress experienced by research animals and to minimize motion artifact during imaging or other measurements. Anesthetized animals must be closely monitored for the safety of the animals and to prevent unintended effects of altered physiology on experimental outcomes. Many currently available monitoring devices are expensive, invasive, or interfere with experimental design. Here, we present MousePZT, a low-cost device based on a simple piezoelectric sensor, with a custom circuit and computer software that allows for measurements of both respiratory rate and heart rate in a non-invasive, minimal contact manner. We find the accuracy of the MousePZT device in measuring respiratory and heart rate matches those of commercial systems. Using the widely-used gas isoflurane and injectable ketamine/xylazine combination, we also demonstrate that changes in respiratory rate are more easily detected and can precede changes in heart rate associated with variations in anesthetic depth. Additional circuitry on the device outputs a respiration-locked trigger signal for respiratory-gating of imaging or other data acquisition and has high sensitivity and specificity for detecting respiratory cycles. We provide detailed instruction documents and all necessary microcontroller and computer software, enabling straightforward construction and utilization of this device.
The method contains the following steps. In step A, supersonic waves are applied to Mountain  Litsea  fruits for excitation and sterilization. In step B, the inferior fruits and the cleaning water are removed from the water tank, placed in a fermentative tank, and left for fermentation. After the fermentation, a pressing and separation process is conducted. In step C, the superior fruits are placed in a separate fermentative tank for fermentation into mofetil alcohol. In step D, the superior fruits are alternatively mixed with pure water, crushed, and placed in a boiler for aging and sterilization. Then the crushed and aged fruits are placed in yet another fermentative tank with pure water for fermentation. After the fermentation, a pomace separation process is conducted. The separated pomace becomes a Mountain  Litsea  wine lees, whereas the separated water becomes a Mountain  Litsea  enzymatic liquid.
The invention discloses a composite medicine preparation for treating gastro-enteritis and gastric ulcer. The composite preparation comprises the following components: three pieces of berberine of 0.1g, four pieces of furazolidone of 0.1g and three pieces of vitamin B6 of 0.5g. The composite preparation has one course for a week, in the first course, administration is carried out for each day with every four hours, and one course can be effective. In the second course, administration is carried out for each day with every six hours; in the third course, administration is carried out for each day with every 8 hours, then the gastrointestinal diseases of gastro-enteritis, gastric ulcer and the like can be radically treated thoroughly. A patient can not drink wine in the courses. In order to consolidate the curative effect, another course can be added, and in the fourth course, administration is carried out for each day with every 8 hours. The invention can cure the gastrointestinal diseases of stomachache, gastric acid, gastrectasia, diarrhea, stomach heat, stomach cold and the like thoroughly.
PROBLEM TO BE SOLVED: To prepare a reducing agent capable of reducing the unpleasant smell by addition thereof to a medicine, a cosmetic or a food, etc., having the unpleasant smell by including a lipid having a negative charge or its salt as an active ingredient therein. SOLUTION: This reducing agent for an unpleasant smell comprises a lipid having a negative charge (phosphatidic acid, phosphatidylinositol, etc.) or its salt (an Na salt, a K salt, etc.) as an active ingredient therein. An acidic phospholipid, its lyso derivative or a salt thereof is preferred as the lipid having the negative charge and can be extracted and separated from a soybean, an egg yolk, a wheat embryo, an animal organ or a plant tissue. The lipid or its salt having the negative charge in an amount of 0.001-50wt.% may be added to a medicine, etc., having the unpleasant smell.
Non-small-cell lung cancer (NSCLC) accounts for approximately 80% of lung cancers diagnosed worldwide. Surgical resection offers the best chance for cure for those patients diagnosed with early-stage disease, however, the vast majority of patients experience eventually relapse or metastasis. The rationale of neoadjuvant or adjuvant chemotherapy for early stage NSCLC lies in the possibility of eradicating micro-metastasis disease, so it appears to improve survival by reducing the occurrence of distant metastases. Meta analysis, CALGB 9633, JBR 10 and ANITA trials have shown postoperative (adjuvant) CT after complete resection will prolong survival. On the other hand, Depierre et al had conducted a trial to demonstrate preoperative (neoadjuvant ) chemotherapy in early stage NSCLC appears to improve survival. We need a head to head trial to comparing neoadjuvant with adjuvant chemotherapy to answer which treatment model is better to early stager NSCLC. Based on proven activity and survival benefit in advance NSCLC, docetaxel has been introduced into neoadjuvant therapy, even as a potential option in adjuvant setting.

Comparison: 3 cycles of TP after complete operation compared to 3 cycles of TP prior to complete resection for NSCLC.
The study is aimed to check a preliminary evidence that bright light may help to lose weight in obese people (Thor Helge Bergan, Norvay, 2002, unpublished). Subjects: aged 20-65 y, BMI \> 30, non-seasonal (SPAQ score \<8, no seasonal problem), in good general health, with regular sleep from 22:00-1:00 to 6:00-9:00. Study season: November-April. Placebo-controlled, single-blind, crossover. At least 1 mo between two arms; at similar phase of menstrual cycle (if present). If could not complete at the first year, the second arm is to be done the next winter. Intervention: Lightbox (4300 lux) - during one arm, deactivated ioniser - during another arm (sequential alternation upon entering the study) for 3 weeks each morning (at least 18 days) starting between 6:00-9:00. Seating distance (from the face to the device) is 41 cm, duration - 30 min. Diet: a target amount of kcal per day is calculated based on age, weight and gender (WHO), e.g. for a woman 40 y ang 80 kg it is 1502 kcal per day. Food content - is also as recommended by WHO. Food distribution over day - usual for the particular test subject but constant over sessions. Food diary is completed daily and subjects calculate kcal themselves based on a Table of kcal. Outcomes: Weight is measured during a visit to doctor a day before and day after the 3-week session, and also at home every week. Motivation and Expectation are rated by 3-point scales in a Diary, at the beginning of each session. Mood, activity and appetite are self-estimated using a VAS-like 10-points scale every week. At the end of each arm the "Easiness of dieting" scale and Adverse event(s) are completed. In the diary, there are also columns for sleep on and off times, intervention time, duration and distance, number of kcal. A target number of subjects to complete the study is 40.
Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind period, all randomized patients in this arm received enalapril 5mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 10 mg b.i.d. at week 4 if they were tolerant to 5 mg b.i.d. Total duration of treatment was up to approximately 40 months.
BACKGROUND: Polyadenosine 5'-diphosphoribose polymerase inhibitors (PARP-Is) are novel, effective agents for treating newly diagnosed epithelial ovarian cancer (EOC). However, the effect of PARP-I on the progression of recurrent EOC has not yet been determined. In particular, there is limited evidence regarding retreatment with PARP-I for recurrent EOC that has progressed on PARP-I in the short term.
CASE REPORT: A 69-year-old woman with a BRCA1 mutated EOC relapsed five months after starting olaparib maintenance following neoadjuvant chemotherapy and interval debulking surgery. Although the platinum-free interval was within six months, secondary cytoreductive surgery was performed because the tumor was locoregional. Following two cycles of weekly nedaplatin, niraparib induced a complete response, and the patient maintained a progression-free status for 15 months.
CONCLUSION: Even with short-term progression on PARP-I, local control combined with different platinum agents and PARP-I can be used to achieve good responses.
After the informed consent form is signed by the patients, general body warming of the patient will be provided with the hot air blowing system after surgery. In the 30th minute of the active heating method, a thermal blanket will be applied to the treated area (extremity) of the patient. The first 24 hours after the application; Pain will be evaluated every hour for the first 8 hours, every 2 hours for the second 8 hours, every 4 hours for the last 8 hours with the VAS Pain Scale and circulation with the Neurovascular Diagnosis Form. Mobilization of the patient for the first time in the 8th hour and for the second time in the 24th hour will be evaluated with the Patient and Observer Mobility Scale. Pain and neurovascular evaluation will be performed every 12 hours on the second postoperative day. Mobility will be assessed for the third time on the second postoperative day.