anthonyyazdaniml/gliner-biomed-curated-corpus huggingface dataset:
Efficacy of XYWAV for the treatment of cataplexy and excessive daytime sleepiness in adult patients with narcolepsy was established in a double‑blind, placebo‑controlled, randomized‑withdrawal study (Study 1; NCT03030599). This study had two parts, consisting of the main study, followed by an optional 24-week open‑label extension (OLE). The main study consisted of a 12‑week open-label optimized treatment and titration period (OL OTTP), followed by a 2-week stable-dose period (SDP), and finally a 2‑week double-blind randomized-withdrawal period (DB RWP).

Study 1 enrolled 201 patients with narcolepsy with cataplexy, 18 to 70 years of age, with a baseline history of at least 14 cataplexy attacks in a typical 2-week period prior to any treatment for narcolepsy symptoms. Of the 201 patients, 134 were randomized 1:1 to continue treatment with XYWAV or to placebo in the 2‑week DB RWP. In the safety population, overall, the median age was 36.0 years (range: 18 to 70). The majority of subjects were female (61%), and most were white (88%) and not Hispanic or Latino (84%).

Patients entering the study were taking a stable dosage of 1) Xyrem only, 2) Xyrem + another anticataplectic, 3) a non-Xyrem anticataplectic, or 4) were cataplexy‑treatment naïve. Patients taking Xyrem at study entry were switched (at a gram for gram dose) from Xyrem to XYWAV for a minimum of 2 weeks and titrated, if needed, to a stable, tolerable, and effective dosage over 8 weeks. Most patients who switched from Xyrem to XYWAV (41/59; 69%) had no change in dosage from study entry to the stable dose period; 27% (16/59) had an increase in dosage, and 3% (2/59) had a decrease in dosage. Among patients whose dosage was changed, most changes were within one titration step (≤1.5 g). Patients not taking Xyrem at study entry were initiated at 4.5 g/night of XYWAV and titrated at a rate of 1 or 1.5 g/night/week to a tolerable dose of XYWAV. Patients taking an anticataplectic other than Xyrem were tapered off the non-Xyrem anticataplectic over 2 to 8 weeks. All patients continued to receive XYWAV only, for the treatment of cataplexy during the last 2 weeks of the OL OTTP.

CNS stimulants were allowed at entry, and approximately 59% of patients continued taking a stable dose of stimulant throughout the SDP and DB RWP. 

The total nightly dose of XYWAV was administered in two equally divided doses in 90% (62/69) of patients. Unequal doses were administered in 10% (7/69) of patients treated with XYWAV.

The primary efficacy endpoint was the change in frequency of cataplexy attacks from the 2 weeks of the SDP to the 2 weeks of the DB RWP. The key secondary endpoint was the change in the Epworth Sleepiness Scale (ESS) score, as a measure of reduction in EDS from the end of the SDP to the end of the DB RWP. 

Patients taking stable doses of XYWAV who discontinued XYWAV treatment and were randomized to placebo during the DB RWP experienced a significant worsening in the average weekly number of cataplexy attacks and in ESS score, compared with patients randomized to continue treatment with XYWAV (see Table 6). 

DB RWP=Double‑blind Randomized-withdrawal Period; SD=standard deviation
PURPOSE: To obtain a preparation containing beeswax in Ahnfeldtia concinna, useful for the topical treatments of all kinds and widths of burns, and having storability for a long period. CONSTITUTION: This preparation contains 1-5% of beeswax in a gel containing 1-50% of propyl and 99-50% of Ahnfeldtia concinna. The further addition of an aloe juice or aloe extract to the preparation enhances the scar formability and anesthetic action of the preparation. The alone imparts an antimicrobial action against specific microorganisms forming colonies to skins for a long storage period. The further addition of placenta enhances the scar formability of the preparation. The preparation is useful not only for the topical treatments of the burns but also for the prevention of sunburns.
Chromatin remodeling is a critical step in the DNA damage response, and the ATP-dependent chromatin remodelers are a group of epigenetic regulators that alter nucleosome assembly and regulate transcription factor accessibility to DNA, preventing genomic instability and tumorigenesis caused by DNA damage. The SWI/SNF chromatin remodeling complex is one of them, and mutations in the gene encoding the SWI/SNF subunit are frequently found in digestive tumors. We review the most recent literature on the role of SWI/SNF complexes in digestive tumorigenesis, with different SWI/SNF subunits playing different roles. They regulate the biological behavior of tumor cells, participate in multiple signaling pathways, interact with multiple genes, and have some correlation with the prognosis of patients. Their carcinogenic properties may help discover new therapeutic targets. Understanding the mutations and defects of SWI/SNF complexes, as well as the underlying functional mechanisms, may lead to new strategies for treating the digestive system by targeting relevant genes or modulating the tumor microenvironment.
SMG9 is an essential component of the nonsense-mediated mRNA decay (NMD) machinery, a quality control mechanism that selectively degrades aberrant transcripts. Mutations in SMG9 are associated with heart and brain malformation syndrome (HBMS). However, the molecular mechanism underlying HBMS remains unclear. We generated smg9 mutant zebrafish (smg9oi7/oi7) that have a lifespan of approximately 6 months or longer, allowing for analysis of the in vivo function of Smg9 in adults in more detail. smg9oi7/oi7 zebrafish display congenital brain abnormalities and reduced cardiac contraction. Additionally, smg9oi7/oi7 zebrafish exhibit a premature aging phenotype. Analysis of NMD target mRNAs shows a trend toward increased mRNA levels in smg9oi7/oi7 zebrafish. Spermidine oxidase (Smox) is increased in smg9oi7/oi7 zebrafish, resulting in the accumulation of byproducts, reactive oxygen species, and acrolein. The accumulation of smox mRNA due to NMD dysregulation caused by Smg9 deficiency leads to increased oxidative stress, resulting in premature aging.
The invention provides novel dental enamel inspired materials for biomedical and dental applications. The materials are apatite-like calcium phosphate complexes and may comprise apatite, octacalcium phosphate crystals, or mixtures thereof. In one embodiment, the materials (calcium phosphate coatings) are mixtures of crystals of apatite and its precursor, octacalcium phosphate, nucleated on a titanium surface. They are prepared using a chemical process leading to the formation of biological apatite which is similar to that found in natural bone and teeth. In one embodiment, the materials are prepared by placing a titanium substrate in a supersaturated calcifying solution containing native or purified recombinant amelogenins. The presence of the amelogenins modulates apatite crystal growth to mimic in vivo apatite crystal formation. Applications for the materials include, without limitation, dental tissue (enamel, dentin, cementum) replacement, orthopeadic implants for bone repair, and coatings for improving the biocompatibility and bone regeneration capability of currently available implants or medical devices made of metallic, polymeric, ceramic or composite materials.
Risk Summary

No data are available regarding the presence of SAPHNELO in human milk, the effects on the breastfed child, or the effects on milk production. Anifrolumab-fnia was detected in the milk of female cynomolgus monkeys administered anifrolumab-fnia. Due to species-species differences in lactation physiology, animal data may not reliably predict drug levels in humans. Maternal IgG is known to be present in human milk. If anifrolumab-fnia is transferred into human milk, the effects of local gastrointestinal exposure and limited systemic exposure in the breastfed infant to anifrolumab-fnia are unknown.

The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for anifrolumab-fnia and any potential adverse effects on the breast-fed child from anifrolumab-fnia or from the underlying maternal condition.
Hydromorphone hydrochloride extended-release tablets were investigated in a double-blind, placebo-controlled, randomized withdrawal study in opioid tolerant patients with moderate-to-severe low back pain. Patients were considered opioid tolerant if they were currently on opioid therapy that was ≥ 60 mg/day of oral morphine equivalent for at least 2 months prior to screening. Patients entered an open-label conversion and titration phase with hydromorphone hydrochloride extended-release tablets, were converted to a starting dose that was approximately 75% of their total daily morphine equivalent dose, and were dosed once daily until adequate pain control was achieved while exhibiting tolerable side effects. Supplemental immediate-release hydromorphone tablets were allowed throughout the study. Patients who achieved a stable dose entered a 12-week, double-blind, placebo-controlled, randomized treatment phase. Mean daily dose at randomization was 37.8 mg/day (range of 12 mg/day to 64 mg/day). Fifty-eight (58) percent of patients were successfully titrated to a stable dose of hydromorphone hydrochloride extended-release tablets during the open-label conversion and titration phase.

During the double-blind treatment phase, patients randomized to hydromorphone hydrochloride extended-release tablets continued with the stable dose achieved in the conversion and titration phase of the study. Patients randomized to placebo received, in a blinded manner, hydromorphone hydrochloride extended-release tablets and matching placebo in doses tapering from the stable dose achieved in conversion and titration. During the taper down period, patients were allowed immediate-release hydromorphone tablets as supplemental analgesia to minimize opioid withdrawal symptoms in placebo patients. After the taper period, the number of immediate-release hydromorphone tablets was limited to two tablets per day. Forty-nine (49) percent of patients treated with hydromorphone hydrochloride extended-release tablets and 33% of patients treated with placebo completed the 12-week treatment period.

Hydromorphone hydrochloride extended-release tablets provided superior analgesia compared to placebo. There was a significant difference between the mean changes from Baseline to Week 12 or Final Visit in average weekly pain intensity Numeric Rating Scale (NRS) scores obtained from patient diaries between the two groups. The proportion of patients with various degrees of improvement from screening to Week 12 or Final Visit is shown in Figure 2. For this analysis, patients who discontinued treatment for any reason prior to Week 12 were assigned a value of zero improvement.

Figure 2.

Percent Reduction in Average Pain Intensity from Screening to Week 12 or Final Visit
Tinea Unguium/onychomycosis is a ubiquitous health problem affecting \~3% of the adult population. It is associated with higher risk for other disease processes. Effective treatment for this disease has been lacking. Oral antifungal agents are associated with high incidence of recurrence of disease, hepatotoxicity, cytochrome P450 Pathway interference, non-compliance, side effects and cost. No effective long-term topical applications have been verified. Debridement of the damaged nail in combination with a broad-spectrum topical antifungal agent and an anti-inflammatory agent is a safe, inexpensive and easily formulated alternative to previous ineffective treatments. The rationale for debridement is simple in that the effectiveness of the topical antifungal is present only when it is in contact with the fungal agent, nail bed and involved diseased tissue. The associated inflammatory response associated with fungal infections is well-established. The only topical NSAID available in the United States is diclofenac sodium. The combination of miconazole, diclofenac sodium and urea has proven effective in this researcher's self-treatment of tinea unguium. Miconazole and diclofenac sodium are well studied and well-established pharmaceutical
NEW MATERIAL:A compound expressed by the formula (n is O or 1). USE:A remedy and preventive for leukemia having human granulocyte colony stimulating factor activity. PREPARATION:For example, a solution of guanidinethiocyanate is added to a human tumorous cell and homogenized, then all PNA is separated by a CsCl density gradient centrifugation method and from this all PNA a poly (A<+>) PNA is screened with an origo (dT) cellulose column, a single stranded cDNA is synthesized by using a reverse transcriptase and converted into a double stranded DNA. Then thus obtained DNA is combined with a proper vector to form a recombinant plasmid, which is inserted into Escherichia coli, etc., to cause transformation thereof. This transformed Escherichia coli is cultured. The compound expressed by the formula is obtained by separating a product from the culture liquid.
The present invention relates to antagonist antibodies or fragments thereof that bind to human OX 40. More specifically, the invention relates to antagonist antibodies or fragments thereof that bind to human OX40, comprising a heavy chain CDR1 comprising the amino acid sequence of SEQ ID NO. 1, and/or a heavy chain CDR2 comprising the amino acid sequence of SEQ ID NO. 2, and/or a heavy chain CDR3 comprising the amino acid sequence of SEQ ID NO. 3; and/or comprises light chain CDR1 comprising the amino acid sequence of SEQ ID NO. 4, and/or light chain CDR2 comprising the amino acid sequence of SEQ ID NO. 5, and/or light chain CDR3 comprising the amino acid sequence of SEQ ID NO. 6.
Obesity is a worldwide prevalent problem which is currently considered a pandemic disease. It is intimately related to several comorbidities that negatively impact physical and mental health. Male sexual dysfunction is not uncommon in people with obesity. This could be attributed to many obesity-associated conditions as diabetes mellitus (DM), hypertension (HTN), and mental and social impairment. Obesity indirectly affects male sexual function by inducing many comorbidities associated with sexual dysfunction. Obesity is also a complex endocrine disorder that can independently alter sexual function through the disruption of various sex hormones. Men with morbid obesity often suffer from deep but reversible sexual dysfunction. Several managements have been introduced to deal with obesity. Dietary intervention, medications, physical exercise are widely used in case of mild and moderate obesity. Meanwhile, bariatric surgery has become the most effective treatment strategy for morbid obese patients which can bring great weight reduction and is expected to ameliorate the comorbidities. Mora et al.'s prospective study showed a bariatric surgery-related significant increase in the IIEF score at 1 year postoperatively. This was found also by the Groutz et al. and Kun et al. However, in a retrospective study by Rosenblatt et al., there was no significant increase in the IIEF scores following RYGB surgery in 23 male patients. Similarly, Sarwer et al., in their prospective study, found that despite the increased postoperative IIEF scores, this difference lied out of significance except for the overall satisfaction.
To assess the effect of Aranesp_ on the hemoglobin (Hgb) of CRI subjects who are recombinant human erythropoietin (rHuEPO)-naïve or converting from rHuEPO therapy. To assess the association between subject self-reported health-related quality of life (HRQoL) as it relates to Hgb concentration and glomerular filtration rate (GFR) in subjects who were rHuEPO-naïve prior to study enrollment. To characterize the health-related resource utilization of subjects with CRI. To characterize the subject satisfaction with Aranesp_ compared to previous rHuEPO therapy. To characterize iron treatment in subjects with CRI. To assess the safety profile of Aranesp_ therapy in subjects with CRI
The surfaces produced comprise single and/or multilayer systems. They are made predominantly of refractory metals and/or their metalloid compounds. The process is based on physical and chemical vacuum coating, with subsequent oxidation. The surfaces contain one or more of titanium, zirconium, niobium, tantalum, aluminum, calcium, magnesium, sodium, potassium, oxygen, nitrogen, boron, carbon and phosphorus. They are deposited initially as metallic layers. The deposited surfaces are anodically-oxidized in an electrolytic process. Thermal- or vacuum plasma oxidation is employed subsequently. Two or more multilayers are deposited in vacuum, under reaction with nitrogen, carbon, oxygen and/or boron. They are oxidized subsequently. The layers are deposited by plasma vapor deposition (PVD) or plasma-enhanced chemical vapor deposition (PECVD) as metallic and then metalloid layers. They are oxidized to a shade between gray-white and white. Anodic oxidation takes place in calcium- and phosphate-containing electrolytes, thereby incorporating calcium and phosphate into the layers. The total layer thickness is 1-20 mu m. Oxidation is incomplete, the initially-applied metal and/or metalloid compound being retained as the intermediate layer.
All patients will receive standard inferior alveolar nerve block of 2% lidocaine with 1:800000 epinephrine and supplemental buccal infiltration of 0.9 mL 2% lidocaine with 1:800000 epinephrine. After five minutes, case group will receive a supplemental buccal infiltration of 30 mg/mL of Ketorolac tromethamine (Alborz-Darou Co. Qazvin, Iran).
The invention concerns a human Pax protein 10.3 and polynucleotide encoding it.  The invention also concerns the process of producing the polypeptide by recombinant DNA technique.  The methods for treating many diseases  e.g. malignant tumor, hemopathy, infection of HIV, immunological diseases and a variety of inflammation etc. utilizing the polypeptide are disclosed.  The invention discloses the antagonist against the polypeptide and therapeutics thereof.  The invention also discloses the uses of the polynucleotide, which encodes a human Pax protein 10.3.
Nine (9) participants will be enrolled and assigned to receive SPR741 400 mg IV over 1 hour, SPR741 400 mg IV over 1 hour + aztreonam 1.0 gram IV over 1 hour, and aztreonam 1.0 gram IV over 1 hour in a randomized sequence. One treatment will be administered during each of 3 dose periods within the assigned treatment arm.
Female first-year psychology students at the University of Groningen will be screened for weight and shape concerns. Those scoring in the clinically relevant range will be invited to participate in the study. After filling out the baseline measures online, the participants will be randomly allocated to a waitlist or an intervention condition. Participants in the intervention condition will follow a weekly 1-hour online intervention with a trainer for six weeks, including homework assignments. In this intervention, the aim is to increase meaning in life and decrease eating disorder symptoms. All study materials will be offered in English, Dutch, or German. Immediately after the intervention and four weeks later, the participants will receive the same questionnaires again as at baseline. The waitlist participants will not receive any intervention during the six-week period between baseline and post-assessment, but receive the same questionnaires in the same timeframe. Waitlist participants will also have the option to receive the intervention after the study has been finished.
In clinical trials, immediate-release oral isosorbide dinitrate has been administered in a variety of regimens, with total daily doses ranging from 30 mg to 480 mg. Controlled trials of single oral doses of isosorbide dinitrate have demonstrated effective reductions in exercise-related angina for up to 8 hours. Anti-anginal activity is present about 1 hour after dosing.

Most controlled trials of multiple-dose oral ISDN taken every 12 hours (or more frequently) for several weeks have shown statistically significant anti-anginal efficacy for only 2 hours after dosing. Once-daily regimens, and regimens with one daily dose-free interval of at least 14 hours (e.g., a regimen providing doses at 8 am, 2 pm, and 6 pm), have shown efficacy after the first dose of each day that was similar to that shown in the single-dose studies cited above. The effects of the second and later doses have been smaller and shorter-lasting than the effect of the first.

From large, well-controlled studies of other nitrates, it is reasonable to believe that the maximal achievable daily duration of anti-anginal effect from isosorbide dinitrate is about 12 hours. No dosing regimen for isosorbide dinitrate, however, has ever actually been shown to achieve this duration of effect. One study of 8 patients, who were administered a pretitrated dose (average 27.5 mg) of immediate-release ISDN at 8 am, 1 pm, and 6 pm for 2 weeks, revealed that significant anti-anginal effectiveness was discontinuous and totaled about 6 hours in a 24-hour period.
To determine whether it is permitted to sell pharmaceuticals etc. via the Internet in accordance with necessary conditions for sales of pharmaceuticals etc.SOLUTION: A sales system for pharmaceuticals etc. is an Internet-based sales system for pharmaceuticals etc. The sales system includes: reception means for receiving input of qualification information, which is information on qualification relating to the purchase of predetermined pharmaceuticals etc., held by a purchaser when selling the prescribed medicines, etc. to the purchaser; inquiry means for inquiring the qualification information received by the reception means to necessary condition information, which is information on conditions necessary for purchasing the predetermined pharmaceuticals etc., and confirming whether the qualification satisfies necessary conditions stipulated in the necessary condition information; and determination means for determining whether it is permitted to sell the predetermined pharmaceuticals etc. to the purchaser. When the inquiry means confirms that the qualification satisfies the necessary conditions, the determination means determines that selling the predetermined pharmaceuticals etc. to the purchaser is permitted.SELECTED DRAWING: Figure 2
A thermochemical process is disclosed that readily produces significantly roughened surfaces on densely sintered alumina. The alumina is reacted with cryolite (Na3AlF6) at a temperature of 300° C.-2075° C. for a time sufficient to produce the desired degree of roughness. This treatment causes controlled dissolution of alumina, controlled cavitation of grain boundaries, and formation of a thin film-reaction product. The resulting surface irregularities enhance subsequent micromechanical or chemical bonding of the densely sintered alumina component. The resulting roughened alumina components have numerous uses in the dental restorative and orthodontic fields, including orthodontic brackets, crowns, onlays, inlays, veneers, and the like. The technique is readily adapted to be used in either a dental office or a laboratory environment.