anthonyyazdaniml/gliner-biomed-curated-corpus huggingface dataset:
FULL PRESCRIBING INFORMATION

WARNING: CONGESTIVE HEART FAILURE AND MYOCARDIAL ISCHEMIA

  * Thiazolidinediones, including rosiglitazone, cause or exacerbate congestive heart failure in some patients [see Warnings and Precautions (5.1)]. After initiation of AVANDIA, and after dose increases, observe patients carefully for signs and symptoms of heart failure (including excessive, rapid weight gain, dyspnea, and/or edema). If these signs and symptoms develop, the heart failure should be managed according to current standards of care. Furthermore, discontinuation or dose reduction of AVANDIA must be considered. 
  * AVANDIA is not recommended in patients with symptomatic heart failure. Initiation of AVANDIA in patients with established NYHA Class III or IV heart failure is contraindicated. [See Contraindications (4) and Warnings and Precautions (5.1).]
  * A meta-analysis of 42 clinical studies (mean duration 6 months; 14,237 total patients), most of which compared AVANDIA to placebo, showed AVANDIA to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction. Three other studies (mean duration 41 months; 14,067 total patients), comparing AVANDIA to some other approved oral antidiabetic agents or placebo, have not confirmed or excluded this risk. In their entirety, the available data on the risk of myocardial ischemia are inconclusive. [See Warnings and Precautions (5.2).]
The invention provides a mitochondria targeted antioxidant with a fluorescence visual function and a preparation method thereof, belonging to the technical field of biological medicine. The novel mitochondrial targeting antioxidant F-Q10 is synthesized by taking a mitochondrial targeting group (F16) as a carrier and taking 2, 3-dimethyl-1, 4-benzoquinone modified by a flexible carbon chain as an antioxidant. The related characterization of the compounds is carried out by nuclear magnetism and mass spectrum. MTT experiments show that F-Q10 has low cytotoxicity and good biocompatibility. The cell imaging capability and the mitochondrial co-localization capability of the laser copolymerization Jiao Tanjiu F-Q10 are used, so that the cell imaging effect is good, the morphology is clear, the fluorescent light is provided, and the mitochondrial co-localization is good. A series of in vitro antioxidation experiment results show that F-Q10 has better antioxidation performance and is enhanced along with the increase of concentration.
Next to osteoarthritis, FMS is the most common arthritis-related disease. Symptoms include musculoskeletal pain, fatigue, headaches, irritable bowel syndrome, morning stiffness, and sleep disturbances. Fluctuating severity, pain, and frustration with the difficulty of diagnosis and treatment lead patients to continually seek help from health care professionals. There is no known cause or cure for this disease.

This study tests the effects of social support and education on the health and well-being of people with fibromyalgia (FMS). We recruited 600 adults with a confirmed diagnosis of FMS from a large health maintenance organization. To be eligible, people had to meet the American College of Rheumatology guidelines for FMS. After we confirmed the diagnosis, we assigned those who agreed to participate to one of three groups. The first group (social support) met with others who suffer from FMS for 2 hours every week for 10 weeks, and then monthly for an additional 10 months. The second group (social support and education) also had 10 2-hour weekly meetings followed by 10 monthly meetings with others who suffer from FMS, and its members learned about the disease and self-management techniques. The third group (control) participated only in the five assessment periods. We assessed people in all three groups before we assigned them to a group, after the intervention, and at yearly follow-ups. The study duration was 4 years.
Functional Hypothalamic Amenorrhea (FHA) is a condition characterized by the absence of menstruation, which is increasingly affecting young women. However, specific recommendations for treating and preventing this condition are lacking. Based on a review of the available literature, this article provides practical and feasible dietary management recommendations for healthcare professionals and researchers in women's health and nutrition. It answers the question of what interventions and nutritional recommendations are necessary to restore menstrual function in women struggling with FHA. Physicians recommend an energy availability threshold of 30 kcal/kg FFM/day to prevent FHA. Also, energy availability below and above this threshold can inhibit LH pulsation and cause menstrual disorders. In addition, the risk of menstrual disorders increases with a decrease in the caloric content of the diet and the duration of the energy deficit, and women with FHA have significantly lower energy availability than healthy women. It is essential to ensure that adequate kilocalories are provided throughout the day (regular meals that are a source of proper glucose) to avoid a negative energy balance, as glucose has been proven to affect LH pulses and T3 and cortisol concentrations in the body. Dietary intervention should focus on increasing the caloric content of the diet, thus increasing energy availability and restoring energy balance in the body. Treatment and diagnosis should also focus on body composition, not just body weight. An increase in body fat percentage above 22% may be required to restore menstrual function. In women with FHA, even an increase in body fat mass of one kilogram (kg) increases the likelihood of menstruation by 8%. It is advisable to reduce the intensity of physical activity or training volume, while it is not advisable to give up physical activity altogether. It is also important to ensure adequate intake of micronutrients, reduce stress, and incorporate cognitive-behavioral therapy.
PROBLEM TO BE SOLVED: To make it possible to adjust the varying intensity of drug actions and drug action period so as to meet the points of application and the cases of application by coating one or both surfaces of a fiber sheet consisting of water absorptive fibers as a base material with medicine-contg. water-soluble resins. SOLUTION: The sheet 21 for medical treatment is constituted by adhering the medicine 24-contg. water-soluble resins 23 onto the water-absorptive fiber sheet 22. The fiber sheet 22 is formed of simple substances or composite of woven fabrics, knitted fabrics, etc., consisting of the water absorptive fibbers as the base material. While the average fiber diameter, base weight, etc., of the constituting fibers are not limited, the ranges of the average fiber diameter of about 5 to 30 microns and the base weight of about 50 to 300g/m<2> are more preferable. Resins which are melted by contact with water or steam, for example, polyvinyl alcohol, etc., are used as the water-soluble resins 23. The one or both surfaces of the fiber sheet 22 are adhered with the water-soluble resins 23 in a dot form, stripe form, etc.  The dot form is more preferable in terms of maintaining the hand of the fiber sheet 22.
Most intrahepatic cholangiocarcinoma (ICC) patients are often accompanied by local or distant metastases and lose the opportunity for surgical resection. For patients with unresectable ICC who have been in stages IIIb and IV (AJCC/UICC, V2, 2018), the survival time is less than 4 months, and there is currently no standard treatment. TheGC chemotherapy (gemcitabine and cisplatin) has been used in the treatment of advanced intrahepatic cholangiocarcinoma, but the efficacy is still unsatisfactory. Lenvatinib is a small molecule multi-kinase inhibitor, the main targets including VEGFR1-3, fibroblast growth factor receptor 1-4, PDGFRα, RET(ret proto-oncogene ), KIT(KIT proto-oncogene, receptor tyrosine kinase), have anti-angiogenic effects, have been proven effective in hepatocellular carcinoma. In recent years, immunological checkpoint inhibitors (ICIs) have shown remarkable therapeutic effects in the treatment of various solid tumors. Combined with other therapies such as chemotherapy and targeted drugs is an important direction to improve the therapeutic effect of immunological checkpoint inhibitors. In this study, the investigators aim to evaluate the efficacy and safety of GC chemotherapy combined with Lenvatinib and immune checkpoint inhibitor PD-L1 antibody Adebrelimab for patients with advanced and unresectable intrahepatic cholangiocarcinoma.
For this study, patients will be stratified into one of the following two arms: 1) head and neck or 2) breast cancer. All study participants will begin using Dermaprazole for 1-2 weeks prior to receiving radiation. During the CT Simulation, study participants will be instructed to apply Dermaprazole in a "patch test" area - an area of the chest outside of the field of radiation. This is to assess for immediate skin reactions including itching, irritation and allergy. If there are no immediate allergic reactions at the conclusion of the simulation visit, the study participant will be instructed to apply the cream in the area that will be irradiated in addition to the patch test area for 1-2 weeks until the radiation starts. During this period, if the patient is found to have no adverse events, they will then continue daily application both in the patch test area and in the radiation field during radiotherapy, and for 2 weeks after they complete their radiation treatment. During the entire time while using the Dermaprazole, study participants will be evaluated for adverse events such as contact dermatitis in the patch test area as well as radiation dermatitis within the treatment field. All participants will be followed for 6 months after the final Dermaprazole application.

Two dose levels of Dermaprazole (1% and 2%) will be evaluated in the combination Phase I/II dose escalation/de-escalation BOIN design study evaluating preliminary efficacy at the Maximum Feasible Dose (MFD). The Dermaprazole will be initiated at a dose of 1% and escalated to 2% as appropriate based on the number of adverse events. A Dose Limiting Toxicity (DLT) will be defined as any of the following: a) any \> Grade 2 skin toxicity outside the radiation field (Macules/ papules covering 10-30% of the area with or without symptoms of pruritus, burning, tightness), b) any \> Grade 2 radiation dermatitis (Moderate to brisk erythema; patchy moist desquamation, mostly confined to skin folds and creases; moderate edema) inside the radiation field that is probably or definitely related to Dermaprazole (AE attribution will be at the discretion of the study PI/Co-I). c) Any \> Grade 4 radiation dermatitis inside the radiation field. A DLT will be detected from the first day the subject starts applying the Dermaprazole cream until 1 month after the subject has completed their last radiation treatment. Dermatitis will be evaluated by a radiation oncologist on a weekly basis using the Common Terminology Criteria for Adverse Events (CTCAE) V5.0 criteria, and all radiation dermatitis scores will be independently verified by a dermatologist who will evaluate the photographs at the end of treatment. Patient reported quality of life will be evaluated using a validated survey instrument called SkinDex16.
The following adverse reactions have been identified during post-approval use of ZOLADEX. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. 

Hypercalcemia: In patients with bone metastases. 

Bone Mineral Density: Osteoporosis, decreased bone mineral density and bone fracture in men [see Patient Counseling Information (17.1)].

Changes in Blood Pressure: Hypotension and hypertension have been reported. These changes are usually transient, resolving either during continued therapy or after cessation of therapy. 

Pituitary Apoplexy and Tumors: Pituitary apoplexy (a clinical syndrome secondary to infarction of the pituitary gland) and pituitary adenoma have been diagnosed. Most of the pituitary apoplexy cases occurred within 2 weeks of the first dose, and some occurred within the first hour. In these cases, pituitary apoplexy has presented as sudden headache, vomiting, visual changes, ophthalmoplegia, altered mental status, and sometimes cardiovascular collapse. Immediate medical attention has been required. Pituitary tumors have been reported. 

Acne: Usually within one month of starting treatment. 

Other Adverse Reactions: Psychotic disorders, convulsions and mood swings.
Cancer will continue to be a major source of morbidity and mortality globally during the foreseeable future. Human papillomavirus (HPV)-related cancer is now a serious problem in both women and men. The most common HPV-related cancer is cervical cancer in females and oropharyngeal cancer in males. Eastern Africa has a high age-standardized incidence of HPV-related cancers, followed in order by Southern Africa, Central Africa, and then the rest of Africa. Among Asian and Oceania countries, Fiji, Papua New Guinea, Solomon Islands, Indonesia, Maldives, and Myanmar have extremely high age-standardized incidences and mortality. Oropharyngeal cancer is less common than cervical cancer, but the age-standardized incidence, for both females and males, is higher in Western Europe, Northern Europe, North America, and Australia/New Zealand. Oropharyngeal cancer incidence rates differ significantly from the rates of cervical cancer within the same countries. In Asia and Oceania, the incidence of oropharyngeal cancer is particularly high among females in Bhutan, Bangladesh, and Australia, and it is highest among males in Bangladesh, New Caledonia, Australia, and French Polynesia. To a certain extent, cervical cancer can be reduced through the development of cervical screening programs and improvements in screening uptake. On the other hand, for oropharyngeal cancer, as of yet, no effective means of cancer screening has been established. Widespread uptake of HPV vaccine will contribute to the reduction of HPV-related cancers in Asia and Oceania, but also in the rest of the world.
Pancreatic cancer is nearly universally fatal, with approximately 38,000 new cases and 34,000 deaths expected in 2008.1 The majority of patients present with disease that is not amenable to curative resection. For patients with metastatic disease, one standard treatment is the combination of gemcitabine with the small molecule epidermal growth factor tyrosine kinase inhibitor erlotinib. This combination results in a modest survival benefit compared to single agent gemcitabine.2

For patients presenting with localized but unresectable disease, the standard treatment remains controversial. Early studies demonstrated that chemotherapy and radiation was superior to either modality alone.3 However, recent studies of systemic therapy alone have typically included a small but real minority of patients with locally advanced disease, supporting that systemic therapy alone is a reasonable treatment option.2 Adding to the confusion are recent European reports that systemic therapy alone may be superior to combined modality therapy, at least when used initially.4 The greatest benefit of external beam radiotherapy may be after a period of full-dose chemotherapy alone, to ensure that rapid metastases do not develop.5 A limitation of beginning treatment with conventional external beam radiotherapy is a requirement to reduce dosing of gemcitabine by 40-50%. Given the safety and preclinical rationale for LDRT, we propose this phase I study to evaluate the safety of LDRT with standard dosing of gemcitabine and erlotinib in patients with locally advanced or limited metastatic pancreatic cancer. Patients will be enrolled in cohorts with escalating doses of low dose radiotherapy. Radiation ports will be uniform between patients as described in Section 5.6 below. As LDRT is administered to sites of disease in liver and abdominal cavity to iliac crest, patients with metastatic disease confined to these areas will be eligible. For patients with locally advanced disease, this protocol also has high rationale, as the overwhelming majority of patients develop and succumb to recurrences in liver and abdominal cavity,10 areas which would be covered by the proposed radiation field. The dose of 2880 cGy is the limit because of kidney and other upper abdominal organ potential for toxicity.
Subjects will be administered a single dose of belimumab 200 mg via the SC route. The dose will be administered in the front of the thigh via auto-injector device.
The invention relates to alkoxy ether branched chitosan, a hydrogel material thereof and a preparation method thereof. The structural formula of the dendronized chitosan is as follows: . According to the invention, alkoxy ether dendronization elements with excellent temperature-sensitive behavior are grafted on chitosan side groups, and chitosan with different grafting rates is prepared by changing the charge ratio between chitosan and alkoxy etherA sugar derivative. The high grafting rate polymer can form gel by direct heating, and the low grafting rate polymer can form hydrogel by adding a cross-linking agent. The method has simple process and mild reaction condition, and does not adopt organic solvent. The hydrogel is low in gelling concentration, short in time, transparent, non-toxic, degradable, excellent in mechanical strength and high in stability, and has intelligent response behaviors such as temperature, pH responsiveness and self-healing. The hydrogel obtained by the invention can be used as a biomaterial and used in the fields of wound dressing, tissue engineering, drug delivery and the like.
The standard of practice in treating children with asthma exacerbations is to give corticosteroid drugs early in the course of the exacerbation. These drugs decrease symptoms, provide faster time to recovery and improve of quality of life. However, there is 100% variability in a child's response to corticosteroids at a standard dose which is based on primarily on adult studies. The pharmacokinetic analysis or the process by which a drug is metabolized by the body is the first step to determine the proper dose.

Patients between the ages of 2 and 16 years with asthma exacerbations will be recruited from the pediatric emergency department. After the patients get the drugs, blood samples will be drawn over 8 hours to get the following parameters: maximum concentration reached in the body, the time for the drug to be eliminated from the body, how long the drug stays in the body, how much of the drug is found in the urine after it is given, and concentration of metabolites or breakdown products in urine and blood. These are the parameters needed to make the pharmacokinetic profile and is the first step towards appropriate dosing of these two medications for asthma exacerbations in children.
Disclosed are a starch-based carrier material with an M cell targeting performance and pH responsiveness, and a preparation method therefor and the use thereof. The molecular structure of the starch-based carrier material is as shown below. The molecular weight of the starch-based carrier material is 7.04×104 - 2.11×106 g/mol, the degree of substitution of carboxymethyl groups is 0.04 - 0.28, and the grafting amount of the targeting peptide GRGDS is 0.01％ - 1.12％ (calculated based on the content of N). The material is insoluble in water when protonated at pH (pH＝1.2) in the stomach, and is slowly soluble in water when deprotonated at pH pH(pH＝6.8) in the small intestine. Therefore, same has good responsiveness to the pH of the gastrointestinal tract, and can efficiently embed positively charged active materials by means of electrostatic interaction, and can protect the active substance from being destroyed and inactivated in the gastrointestinal tract; and same can also target M cells to improve the efficiency of the M cells transporting the active substance, thereby increasing the bioavailability thereof. (I)
The investigators are building on previous work to identify opportunities to meet the needs of perinatal fathers. The term perinatal encompasses the time leading up to and immediately following the birth of a child. Father involvement in child rearing is beneficial to mothers and children, but fathers are routinely overlooked by available support opportunities at the transition to parenthood. This pilot project seeks to apply research evidence and best practices to address the disparity in socioemotional community support and education programs serving perinatal fathers. In a previous pilot study, the investigators learned from fathers participating in focus groups that participants were interested in opportunities to connect with other fathers in the same life stage to talk about personal experiences and learn from each other. The investigators also learned that fathers worry about meeting varied role expectations, that available resources tend to overlook the unique experiences of fathers, and that it can be challenging to find quality information in a digital world saturated with conflicting information about parenting. This project seeks to address these primary issues through community-based, father-centric support and educational programs. WCNC education staff will facilitate a discussion-based group mentoring program for fathers who are expecting or recently had a baby. This program seeks to increase connection with other fathers, reduce stress related to parenting a baby, and increase parenting confidence. The investigators plan to evaluate the feasibility of the program through satisfaction surveys and other measures of the program's implementation. The investigators also plan to evaluate the effectiveness of the program by providing participants with surveys asking about their well-being, knowledge, confidence in parenting, and their satisfaction with their social networks. The investigators are additionally developing educational podcasts focused on topics relevant to prenatal and postpartum fathers, which will be evaluated as a supplementary component to the mentoring program. Research objectives are the following: Study 1, Objective 1 (Primary): The investigators seek to determine the feasibility and acceptability of a program targeting perinatal fathers offered in a community clinic setting. Study 1, Objective 2 (Primary): Examine whether participating in a discussion-based group mentoring program increases the likelihood of positive short-term outcomes for fathers. Study 1 Objective 3 (Secondary): Identify whether listening to brief, targeted educational podcasts predicts increased positive outcomes for fathers over and above the mentoring group alone. Study 2 Objective 1 (Primary): Identify whether participants who listen to brief, targeted educational podcasts find the podcasts satisfactory and acceptable as a method of gaining information about perinatal fatherhood.