anthonyyazdaniml/gliner-biomed-curated-corpus huggingface dataset:
Nefazodone hydrochloride tablets USP are an antidepressant for oral administration with a chemical structure unrelated to selective serotonin reuptake inhibitors, tricyclics, tetracyclics, or monoamine oxidase inhibitors (MAOI).

Nefazodone hydrochloride is a synthetically derived phenylpiperazine antidepressant. The chemical name for nefazodone hydrochloride is 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-5-ethyl-2,4-dihydro-4-(2-phenoxyethyl)-3H-1,2,4-triazol-3-one monohydrochloride. The structural formula is:

C25H32CIN5O2•HCl M.W. 506.5

Nefazodone hydrochloride is a nonhygroscopic, white crystalline solid. It is freely soluble in chloroform, soluble in propylene glycol, and slightly soluble in polyethylene glycol and water.

Nefazodone hydrochloride tablets USP are supplied as capsule-shaped tablets containing 50 mg, 100 mg, 150 mg, 200 mg, or 250 mg of nefazodone hydrochloride and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and povidone. Additionally, the 50 mg tablets include ferric oxide red as a colorant, the 150 mg tablets include ferric oxide red and yellow as colorants, and the 200 mg tablets include ferric oxide yellow as a colorant.
The present invention particularly refers to a recombinant protein which is specifically recognized by antibodies in the serum of patients infected with Influenza A H1N1 outbreak 2009 and which is proposed as a vaccine or as a main active ingredient of a vaccine produced in Escherichia Coli against Influenza A H1N1 that caused the epidemic outbreak 2009. Said protein is a fragment of the Hemagglutinin protein of the Influenza A H1N1 outbreak 2009 expressed in Escherichia coli strains. Additionally, the invention presents and protects a process through which said main active ingredient for a recombinant vaccine against Influenza A H1N1 causing the epidemic outbreak 2009 is obtained and purified through E coli cultures. The proteins including in the structure thereof the amino acid sequence SEC ID No. 1 or SEC ID No. 2 or SEC ID No. 3 are particularly protected. The use of said proteins as vaccines or active ingredients of a vaccine against Influenza A H1N1 outbreak 2009 is also protected. The invention also protects the process through which the aforesaid protein is produced, including a suitable level of biological activity and at amounts and levels of purity that ensure the proposed process to be applied in the industry.
Pregnancy loss after Day 40 in mares usually results in the expulsion (abortion) of the fetus and placental membranes. However, fetal retention within the uterus is also a possible outcome, leading to either fetal mummification or maceration. Fetal maceration is septic decomposition of fetal tissues within the uterus following failure of expulsion. It requires the presence of bacteria and oxygen within the uterus, likely originating from an open cervix, and results in tissue autolysis, leaving only fetal bones remaining in the mare. Fetal maceration is a rare complication of pregnancy in mares that is usually associated with a recent history of abortion, a persistent vaginal discharge, and retention of numerous fetal bones. Here, we report 2 cases of fetal maceration with retention of only a few fetal bones in mares that were presented without noticeable clinical signs. Key clinical message: The unusual presentation of fetal maceration in these mares (only a few fetal bones and no noticeable clinical signs) brings attention to the potential insidious nature of fetal retention. It highlights the importance of a thorough reproductive examination before breeding, along with careful and ongoing monitoring after breeding and throughout pregnancy.
The main objective of this study was to determine the overall response rate of patients treated with at least 2 cycles of topotecan and docetaxel. The secondary objectives were to determine the feasibility and toxicities of this combination. The final secondary objective is overall survival for patients that received 2 or more cycles.

Methods: Eligible pts with recurrent small cell lung cancer had to be at least 3 months from initial treatment. Pts received Docetaxel 30 mg/m2 IV followed by Topotecan 3 mg/m2 IV Days 1 and 8 of a 21 day cycle. Disease assessment was done every 2 cycles. Toxicity was measured each cycle.
Before the intervention, the study design with use of hypothetical scenarios will be explained to the participant. The concept of randomization will be also be explained. The participants will be asked a few questions to assess their understanding of the study design, specifically the hypothetical nature of the scenarios. We will also assess whether they understand the concept of being randomized to see one website first and then the other. Only those participants that understand the study design will be invited to participate in the intervention and will be randomized. For subjects that are randomized, a survey will be administered verbally to collect demographic information and information about their kidney disease and comorbidities. The functional health literacy and numeracy assessment and health status questionnaire will be completed. Subjects will be stratified by the transplant center site and then block randomized. One group will be shown the existing SRTR website with its existing SRTR report cards and then the website with the new patient-centered AHRQ report cards for kidney transplants. The other group will be shown the two websites in opposite order. Each participant will have at most 30 minutes to view each of the websites. After viewing each website, responses to the intervention will be collected. Sessions where participants are reviewing the websites will be recorded using Zoom. Figure 2 shows the study design whereby subjects will be block randomized once to one of the four groups consisting of 18 subjects each. At the end of the study, the patients will have access to both the websites.

The study interventions can be administered in person on a laptop. During the COVID-19 pandemic, the intervention can be administered remotely via email and zoom. The link to the websites will be sent via encrypted email and the intervention will be recorded via zoom. The recordings for subjects at Hennepin Healthcare will be stored on computers at that site.

If participant does not have your own electronic device or internet, the study will send the participant a study iPad with internet that participant can use for the intervention and then to send back to the study team. We will provide detailed instructions on how to use the iPad and Zoom application. The study will also pay for a FedEx pick up from the participants' home to return the iPad to the study team after the completion of the intervention.
Firstly, according to the inclusion and exclusion criteria, all patients from the First Affiliated Hospital of the University of South China who were to undergo robot-assisted pancreaticoduodenectomy were randomized into two groups, namely the standard approach group and the intermediate approach group. The two groups were under the management of the same surgical team throughout the perioperative period, and were managed according to standardized Enhanced recovery after surgery approach. The brief procedure includes: (1) Placement of the trocar in appropriate place; (2) An ultrasonic knife was used to cut the appetizing colonic ligament and expose the pancreas. The superior mesenteric vein, common hepatic artery, proper hepatic artery and gastroduodenal artery were exposed, and the adjacent lymph nodes were dissected. The right gastric artery and gastroduodenal artery were resected to expose the portal vein. Dissect the common bile duct and peel the gallbladder from the bile fossa; The free common bile duct was dissected and suspended with a vascular sling. (3) Resection of distal stomach and jejunum. The pancreas was cut off with ultrasonic knife. (4) Child reconstruction - pancreaticojejunostomy (pancreatic duct to jejunal mucosa anastomosis) , cholangiojejunostomy and gastrojejunostomy were adopted. (5) Thoroughly rinse the abdominal cavity and place the abdominal drainage tube properly after checking for no active bleeding.The key point of surgery in the standard approach group was to first reveal portal vein-superior mesenteric vein and gradually complete the resection of the uncinate process of pancreas based on the reference of portal vein-superior mesenteric vein. In the intermediate approach group, the area between superior mesenteric vein and superior mesenteric artery was defined as the intermediate area and dissection was performed in this area to achieve the removal of the uncinate process of pancreas. Subsequently, data related to intraoperative conditions (such as operation time, amount of blood loss, etc.) and postoperative complications were collected and statistically analyzed to verify the safety of the intermediate approach, and short-term prognostic data was collected to verify its effectiveness.
The optimal positioning of the head-of-bed (HOB) has remained controversial in the neurosurgical field. Very limited data exists outlining the effects of HOB positioning in subarachnoid hemorrhage (SAH) patients. One study by Schulz-Stubner and Thiex assess the effects of HOB positioning in SAH and traumatic brain injury (TBI) patients. While this study offers some valuable insight into the changes in cerebral hemodynamics seen when the HOB changes, it congregates data from two very different pathologies. This could potentially misrepresent the true effects patients experience. A study by Kung et al. assesses cerebral blood flow dynamics and HOB changes in the setting of SAH but does not evaluate the effects on intracranial pressure (ICP) (Kung, et al., 2013). There appear to be no studies which evaluate the effect of HOB positioning on ICP in patients with SAH. No current data exists to determine if dependent leg positioning would help to further lower ICP. Theoretically, placing a patient's legs in a dependent position would lead to increased venous pooling of blood in the legs which might translate to lower ICP.
A water-retaining sheet is formed of a non-woven fabric that contains, at a rate of 50 mass% or greater, a highly elastic fiber having a Young's modulus of 30 cN/T or greater. The highly elastic fiber may be a core-sheath conjugate fiber. The sheath part of the core-sheath conjugate fiber may be formed of an ethylene/vinyl alcohol copolymer and the core part thereof may be formed of a hydrophobic resin. The average fineness of the highly elastic fiber may be about 1.5-10 dtex. When this water-retaining sheet is pressed with a finger in a state of being impregnated with a liquid component such as a beauty lotion, the liquid component can quickly return. Thus, the water-retaining sheet is appropriately usable as a face mask.
The genetic bases of Alzheimer's disease (AD) and frontotemporal dementia (FTD) have been comprehensively studied, which is not the case for atypical cases not classified into these diagnoses. In the present study, we aim to contribute to the molecular understanding of the development of non-AD and non-FTD dementia due to hyperammonemia caused by mutations in urea cycle genes. The analysis was performed by pooled whole-exome sequencing (WES) of 90 patients and by searching for rare pathogenic variants in autosomal genes for enzymes or transporters of the urea cycle pathway. The survey returned two rare pathogenic coding mutations leading to citrullinemia type I: rs148918985, p.Arg265Cys, C>T; and rs121908641, p.Gly390Arg, G>A in the argininosuccinate synthase 1 (ASS1) gene. The p.Arg265Cys variant leads to enzyme deficiency, whereas p.Gly390Arg renders the enzyme inactive. These variants found in simple or compound heterozygosity can lead to the late-onset form of citrullinemia type I, associated with high ammonia levels, which can lead to cerebral dysfunction and thus to the development of dementia. The presence of urea cycle disorder-causing mutations can be used for the early initiation of antihyperammonemia therapy in order to prevent the neurotoxic effects.
The study is a type 2 hybrid implementation effectiveness trial, whose objective is to simultaneously test the clinical intervention and the implementation strategy. The study will take place in 4 phases, the first being pre-implementation, whose objective is to gather information about local characteristics, barriers and facilitators, and constitute the implementation team. During the second phase, the implementation team will be responsible for structuring the actions for the implementation of the intervention, adapting it to the context defined in phase 1, developing strategies for the training of primary care workers. In phase 3, we will implement the intervention either using a software or a booklet for people with diabetes and we will monitor the participants' diabetes-related, functional and quality of life outcomes after the 12 weeks of intervention. Reach, adoption and implementation will be evaluated using the RE-AIM tool. In phase 4 - _maintenance - _the municipality will be responsible for maintaining, expanding and improving the changes achieved, promoting the sharing of experience with other public and private institutions, facilitating the diffusion of similar programs. Specifically in the phase 3, a randomized controlled trial will be performed with 356 patients with diabetic neuropathy. The participants will be randomly assigned into either a control group (recommended foot care by international consensus with no foot exercises) or an intervention group that will perform face to face exercises, supervised by physiotherapists for 12-weeks. The subjects will be evaluated in 2 different times to access the effect of the intervention: baseline and 12 weeks, for all outcomes. The following outcomes will be assessed in all times: (1) diabetic neuropathy symptoms by Michigan Neuropathy Screening Instrument, (2) range of motion of the ankle and first metatarsophalangeal joint, (3) fuzzy score of the neuropathy severity, (4) Time up and go, (5) hallux and toes strength (by a pressure plate measurement , (6) hallux strength (by the enhanced paper grip test),(7) ulcers and pre-ulcerative lesions and (8) quality of life (EQ-5D). The hypothesis of this study is that the intervention will reduce the symptoms of diabetic neuropathy, increase the strength of the foot muscles, decrease the severity of the diabetic neuropathy (fuzzy score), decrease the number of neuropathy symptoms, as well increase range of motion, functionality and quality of life.
In two controlled trials involving 763 patients with esophageal candidiasis, 445 adults with endoscopically-proven candidiasis received Micafungin for Injection, and 318 received fluconazole for a median duration of 14 days (range 1 to 33 days).

Micafungin for Injection was evaluated in a randomized, double-blind study which compared Micafungin for Injection 150 mg/day (n = 260) to intravenous fluconazole 200 mg/day (n = 258) in adults with endoscopically-proven esophageal candidiasis. Most patients in this study had HIV infection, with CD4 cell counts less than 100 cells/mm3. Outcome was assessed by endoscopy and by clinical response at the end of treatment. Endoscopic cure was defined as endoscopic grade 0, based on a scale of 0 to 3. Clinical cure was defined as complete resolution in clinical symptoms of esophageal candidiasis (dysphagia, odynophagia, and retrosternal pain). Overall therapeutic cure was defined as both clinical and endoscopic cure. Mycological eradication was determined by culture, and by histological or cytological evaluation of esophageal biopsy or brushings obtained endoscopically at the end of treatment. As shown in Table 10, endoscopic cure, clinical cure, overall therapeutic cure, and mycological eradication were comparable for patients in the Micafungin for Injection and fluconazole treatment groups.

Most patients (96%) in this study had C. albicans isolated at baseline. The efficacy of Micafungin for Injection was evaluated in less than 10 patients with Candida species other than C. albicans, most of which were isolated concurrently with C. albicans.

Relapse was assessed at 2 and 4 weeks post-treatment in patients with overall therapeutic cure at end of treatment. Relapse was defined as a recurrence of clinical symptoms or endoscopic lesions (endoscopic grade greater than 0). There was no statistically significant difference in relapse rates at either 2 weeks or through 4 weeks post-treatment for patients in the Micafungin for Injection and fluconazole treatment groups, as shown in Table 11.

In this study, 459 of 518 (88.6%) patients had oropharyngeal candidiasis in addition to esophageal candidiasis at baseline. At the end of treatment 192/230 (83.5%) Micafungin for Injection-treated patients and 188/229 (82.1%) of fluconazole-treated patients experienced resolution of signs and symptoms of oropharyngeal candidiasis. Of these, 32.3% in the Micafungin for Injection group, and 18.1% in the fluconazole group (treatment difference = 14.2%; 95% confidence interval [5.6, 22.8]) had symptomatic relapse at 2 weeks post-treatment. Relapse included patients who died or were lost to follow-up, and those who received systemic antifungal therapy during the post-treatment period. Cumulative relapse at 4 weeks post-treatment was 52.1% in the Micafungin for Injection group and 39.4% in the fluconazole group (treatment difference 12.7%, 95% confidence interval [2.8, 22.7]).
Risk Summary

There is no information available on the presence of paricalcitol in human milk, the effects of the drug on the breastfed infant or the effects of the drug on milk production. Studies in rats have shown that paricalcitol and/or its metabolites are present in the milk of lactating rats; however, due to specifies-specific differences in lactation physiology, animal data may not reliably predict drug levels in human milk [see Data]. Because of the potential for serious adverse reactions, including hypercalcemia in a breastfed infant, advise patients that breastfeeding is not recommended during treatment with Paricalcitol.

Data 

Following a single oral administration of 20 mcg/kg of radioactive [3H] paricalcitol to lactating rats, the concentrations of total radioactivity was determined. Lower levels of total radioactivity were present in the milk compared to that in the plasma of the dams indicating that low levels of [3H] paricalcitol and/or its metabolites are secreted into milk. Exposure of the pups to[3H] paricalcitol through milk was confirmed by the presence of radioactive material in the pups’ stomachs.
Experimental Design: For 3 consecutive days/pattern, the participants will consume the respective treatment, at home, between 7-9 am and refrain from eating or drinking anything other than water until 12:00pm. On day 3, the participants will consume a standardized dinner at home the night before testing. On day 4, the participants will report to the research facility between 6-8 am to complete each 5-h testing day. Upon arrival to the facility, each participant will become familiarized with the testing day procedures. At time -15 min, a baseline set of computerized questionnaires (and/or blood samples) will be completed. At time +0 min, the respective breakfast treatment will be provided. Immediately following the first swallow of the breakfast meal, the participants will be given a questionnaire assessing the palatability. The participants will consume the breakfast within 20 min. After breakfast, the participants will continue to complete the questionnaires (and/or blood samples) every 30 min throughout the 5-h postprandial period. Throughout the day, the participants will also indicate if/when they would like to eat again. Regardless of the participants' meal timing request, at +240min post-breakfast, the participants will be provided with an ad libitum lunch. For the lunch meal, the participants will be given 30 min to "consume as much or as little as possible until comfortably full." Following these procedures, the participants will be allowed to leave the facility. The next day, a dietary recall will be performed to assess daily energy intake across the previous day. Lastly, on day 5 (at home), the participants will be provided with their respective breakfast along with additional carbohydrate and/or fat foods. Once the treatment breakfast is consumed, the participants can select and consume as much of the additional foods as they wish to consume within the breakfast time period (30 minutes).
The proposed study is a single center, randomized and controlled human study to optimize controlled human malaria infection (CHMI) administered by direct venous inoculation (DVI). 30 to 36 participants will be randomized to one of five groups and will be inoculated with PfSPZ Challenge DVI. All participants recruited will be healthy adults aged between 18 and 45 years. The study duration is 4 months, participation duration is estimated to be 2 months. Safety and infectivity data will be collected for each study product and dose-level. Sera will be collected at baseline and at study day 29 for antibody assays. Participants, and clinical and laboratory investigators will be blinded to group allocation. The study primary endpoint will be reached at study day 29, at which time an interim study report will be generated. The investigators, the sponsor, the data and statistical analysis team, and Sanaria staff will meet in person or by teleconference on day 43 to review infection, pre-patent period, and adverse event results. These results will be made available to members of the International PfSPZ Consortium (I-PfSPZ-C) and if required, to regulatory authorities, including the FDA, to facilitate other PfSPZ Challenge CHMI studies with the appropriate disclaimers. Participants will be followed as outpatients for malaria diagnosis, treatment and follow-up to study day 57. Malaria positivity will be determined by qPCR diagnostics with microscopy as a backup. Participants who test positive for malaria and those who remain negative at study day 29 will be treated with oral atovaquone-proguanil. The primary objective of this study is to assess the safety and reactogenicity of PfSPZ Challenge administered by DVI using 7G8 and NF54 P. falciparum strains. Secondary objectives are to 1) assess the infectivity of four escalating doses of direct venous inoculation (DVI) of the 7G8 clone in comparison with an established dose (100% infective) DVI of the NF54 strain and 2) assess the time to malaria patency for escalating doses of the 7G8 clone compared to a single dose of the NF54 strain.