anthonyyazdaniml/gliner-biomed-curated-corpus huggingface dataset:
OBJECTIVES: I. Determine the maximum tolerated dose and dose-limiting toxicity of PS-341 in patients with hematologic malignancies. II. Determine the pharmacodynamics of this drug in these patients. III. Determine response to this drug in these patients. IV. Determine the correlation between response of malignancies and proteasome inhibition and apoptosis in peripheral blood mononuclear cells (PBMC) of these patients. V. Determine the correlation between therapy toxicity and proteasome inhibition and apoptosis in PBMC of these patients. VI. Determine the effect of this drug on other molecular markers (i.e., BCL-2 in follicular lymphoma patients and t9;22/BCR/ABL in chronic lymphocytic leukemia patients). VII. Determine the correlation between interleukin-6 serum levels in multiple myeloma patients and drug dosing, toxicity of therapy, extent of protease inhibition, response to therapy, and apoptosis in PBMC of these patients.

OUTLINE: This is a dose-escalation, multicenter study. Patients receive PS-341 IV over 30 minutes on days 1, 4, 8, 11, 15, 18, 22, and 25 followed by a 2-week rest. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of PS-341 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study.
The selection of appropriate doses for Part B will be performed upon consideration of available safety and tolerability and PK data from Part A and/or any preceding repeat dose cohorts. The subjects will receive GSK2849466 in ratio of 3:1.with placebo.
Sham HD-tDCS will be delivered over pre-SMA or left-dlPFC cortex. The same electrodes placement as well as the stimulation set-up will be used as in the active stimulation conditions, but the current will be applied for 30 s and will be ramped down (0 mA) during the rest of the session without the participants awareness.
Disclosed embodiments concern a combination comprising a JAK inhibitor and an immunooncology agent. The immunooncology agent may comprise an anti-PD- 1 antibody, anti- PD-L1 antibody, PI3K inhibitor, indole dioxygenase inhibitor or a combination thereof. The JAK inhibitor may be a pyrimidin-2-amine, 2,4-pyrimidinediamine, or a combination thereof. Also disclosed are embodiments of a method for using the combination to treat a subject, particularly a subject having a cell proliferative disorder. The method may further comprise administering one or more therapeutic agents in addition to the JAK inhibitor and immunooncology agent. Kits comprising the combination are also disclosed.
This study will be conducted in two stages. In the DTP booster phase subjects will receive a booster dose of Tritanrix-HepB/Hib-MenAC or Tritanrix-HepB/Hib (active control) at 15 to 24 months in a single-blind manner so that the subjects' parents will not know which vaccine was administered to their child (this booster phase is no longer recruiting). In the Mencevax ACWY phase at 24-30 months a dose of Mencevax ACWY will be given to subjects who were not boosted with a MenA conjugate and/or MenC containing vaccine at 15-24 months in an open manner (this booster phase is not yet recruiting). Up to four blood samples will be taken: before and one month after the administration of the DTP booster dose and of Mencevax ACWY. To comply with the immunisation calender of Thailand, at 15-24 months all subjects will receive OPV. At 16-25 months 2 doses of Japanese Encephalitis (JE) vaccine or a dose of varicella vaccine will be offered and at 25-31 months a dose of varicella or JE vaccine will be offered.
A method for reusable medical device reprocessing compliance and a system for environmental or device hygiene standard compliance. For example, in the method, the reusable medical device is reprocessed before performing the second medical procedure and after performing the first medical procedure using the reprocessing procedure and the reprocessing data is uploaded. The method uses a reusable medical device to perform a first medical procedure, and first medical procedure data is uploaded. The reusable medical device is interactively verified prior to performing the second medical procedure, including querying the details of the procedure providing the instructions. A second medical procedure is performed using the reusable medical device, and second medical procedure data is uploaded. An alert is automatically generated based on comparing the first medical procedure data, the procedure details, the second medical procedure data, and the reprocessing data to the hygiene standard. The alert indicates a non-compliance with the hygiene standard(s).
Eligible patients will be enrolled as outlined below. Prior to initiation of Li-ESWT treatments, patients will complete validated questionnaires to assess erectile function. In addition, patients will undergo induction of artificial erection in clinic with assessment of penile blood flow using penile Doppler. Intracavernosal pressure measurements will be obtained. A corporal aspirate will be drawn and examined for levels of neuronal nitric oxide synthase, endothelial nitric oxide synthase, brain-derived neurotropic factor and vascular endothelial growth factor. Patients will then receive twice-weekly Li-ESWT treatments of 0.2mJ/mm\^2 over 3 treatment sites along the dorsal penile shaft, 1500 shocks per treatment (500 shocks per treatment site), for a total of 3000 shocks per week, for 6 weeks of treatment (totally 18,000 shocks). Following Li-ESWT treatments, patients will complete the same validated questionnaires, penile Doppler studies, corporal aspirates and measurement of intracavernosal pressures immediately following the final Li-ESWT treatment, 4-6 weeks following completion of treatment, and again at 3 and 6 months following completion of treatment.
A tablet having first and second surfaces opposite to each other and a side surface lying perpendicular to any one of the first and second surfaces. A peripheral tablet edge delimited between each of the first and second surfaces and the side surface is chamfered to provide a respective inclined peripheral edge face over the entire perimeter of the tablet. This tablet also has at least first generally V-sectioned score defined in the first surface so as to leave two tablet divisions of uniform size on respective sides of the V-sectioned first score. A pair of generally V-sectioned side scores are defined in the side surface of the tablet at respective locations opposite to each other and continued to opposite ends of the V-sectioned first score. The tablet can be divided along the V-sectioned score in the first surface by the application of a minimized finger pressure. The tablet of the invention is particularly suited in a pharmaceutical field.
Previous studies have shown associations between children's exposure to phthalates and neurodevelopmental disorders. Whereas the impact of exposure to phthalate alternatives is understudied. This study aimed to evaluate the association of exposure to phthalates/their alternatives with the risk of dyslexia. We recruited 745 children (355 dyslexia and 390 non-dyslexia) via the Tongji Reading Environment and Dyslexia Research Project, and their urine samples were collected. A total of 26 metabolites of phthalates/their alternatives were measured. Multivariate logistic regression and quantile-based g-computation were used to estimate the associations of exposure to the phthalates/their alternatives with dyslexia. More than 80% of the children had 17 related metabolites detected in their urine samples. After adjustment, the association between mono-2-(propyl-6-hydroxy-heptyl) phthalate (OH-MPHP) with the risk of dyslexia was observed. Compared with the lowest quartile of OH-MPHP levels, the odds of dyslexia for the third quartile was 1.93 (95% CI 1.06, 3.57). Regarding mixture analyses, it was found that OH-MPHP contributed the most to the association. Further analyses stratified by sex revealed that this association was only observed in boys. Our results suggested a significantly adverse association of di-2-propylheptyl phthalate exposure with children's language abilities. It highlights the necessity to prioritize the protection of children's neurodevelopment by minimizing their exposure to endocrine-disrupting chemicals like di-2-propylheptyl phthalate.
Concentration-dependent QT prolongation occurred in an uncontrolled, open-label QT sub-study in previously treated patients with BRAF V600E mutation-positive metastatic melanoma [see Clinical Pharmacology (12.2)]. QT prolongation may lead to an increased risk of ventricular arrhythmias, including Torsade de Pointes.

Do not start treatment in patients with uncorrectable electrolyte abnormalities, QTc > 500 ms, or long QT syndrome, or in patients who are taking medicinal products known to prolong the QT interval. Prior to and following treatment initiation or after dose modification of ZELBORAF for QTc prolongation, evaluate ECG and electrolytes (including potassium, magnesium, and calcium) after 15 days, monthly during the first 3 months, and then every 3 months thereafter or more often as clinically indicated.

Withhold ZELBORAF in patients who develop QTc > 500 ms (Grade 3). Upon recovery to QTc ≤ 500 ms (Grade ≤ 2), restart at a reduced dose. Permanently discontinue ZELBORAF treatment if the QTc interval remains > 500 ms and increased > 60 ms from pre-treatment values after controlling cardiac risk factors for QT prolongation (e.g., electrolyte abnormalities, congestive heart failure, and bradyarrhythmias) [see Dosage and Administration (2.3)].
Baseline Genotype/Phenotype and Virologic Outcome Analyses

In TMC125-C206 and TMC125-C216, the presence at baseline of the substitutions L100I, E138A, I167V, V179D, V179F, Y181I, Y181V, or G190S was associated with a decreased virologic response to etravirine. Additional substitutions associated with a decreased virologic response to etravirine when in the presence of 3 or more additional 2008 IAS-USA defined NNRTI substitutions include A98G, K101H, K103R, V106I, V179T, and Y181C. The presence of K103N, which was the most prevalent NNRTI substitution in TMC125-C206 and TMC125-C216 at baseline, did not affect the response in the INTELENCE® arm. Overall, response rates to etravirine decreased as the number of baseline NNRTI substitutions increased (shown as the proportion of subjects achieving viral load < 50 plasma HIV RNA copies/mL at Week 48) (Table 7).

Response rates assessed by baseline etravirine phenotype are shown in Table 8. These baseline phenotype groups are based on the select subject populations in TMC125-C206 and TMC125-C216 and are not meant to represent definitive clinical susceptibility breakpoints for INTELENCE®. The data are provided to give clinicians information on the likelihood of virologic success based on pre-treatment susceptibility to etravirine in treatment-experienced patients.

The proportion of virologic responders (viral load < 50 HIV-1 RNA copies/mL) by the phenotypic susceptibility score (PSS) of the background therapy, including enfuvirtide, is shown in Table 9.
PCT No. PCT/JP96/01543 Sec. 371 Date Feb. 7, 1997 Sec. 102(e) Date Feb. 7, 1997 PCT Filed Jun. 6, 1996 PCT Pub. No. WO96/41814 PCT Pub. Date Dec. 27, 1996The present invention relates to a peptide represented by the general formula (1):   HHisSerAspABPheThrAspCTyrD (1) ArgEArgFGlnGAlaValIJTyrLeuK LMLeuN  wherein A is Ala or Gly; B is Ile or Val; C is Asn or Ser; D is Thr or Ser; E is Leu or Tyr; each of F, I and J is Lys or Arg, and at least one of F, I and J is Arg; G is Met, Leu or Nle; K is Asn or Ala; L is Ser or Ala; M is Ile or Val; and N is -NH2 or Asn-NH2, excluding the combination where A is Ala, B is Val, C is Asn, D is Thr, E is Leu, K is Asn, L is Ser, M is Ile, and N is Asn-NH2, and pharmaceutically acceptable salts thereof, as well as to a bronchus-expanding agent or a blood-flow-improving agent comprising said peptide or a pharmaceutically acceptable salt thereof as an active ingredient.
FIELD: medicinal industry. SUBSTANCE: sealed ampoules containing dry interferon preparation were placed in casettes and subjected for two-fold irradiation on gamma-unit RDS-60 at total dose 15-25 kGr. This treatment provides the complete inactivation of any possible contaminating viruses and, therefore, the complete safety with respect to lymphotropic viruses. Antiviral activity of interferon is retained after treatment. The treated interferon exhibits safety, sterility, absence of toxicity. EFFECT: improved method of inactivation.
Under full aseptic conditions and wearing sterile gloves while the patient is in setting position, skin infiltration will be done with 2 ml of 1% lidocaine, then an 18-G Epidural needle with a 20-G catheter (Perifix, B.Braun, Germany) will be inserted through the T6-T7 interspace, and the epidural space located using the loss of resistance technique. The catheter then advanced approximately 3 cm cephalic. A test dose of 3 ml of 1% lidocaine containing epinephrine in a ratio of 1:200,000 administered to detect unintentional intrathecal or IV injection. After negative response, 15 ml of 0.25% epidural bupivacaine will be injected and the patient will be turned to the supine position.
The present invention relates to a method for preparing a glycyrrhizic acid ternary complex nanometer particle. The present glycyrrhizic acid medicine has the defect of difficult absorption. The ternary complex nanometer particle enhances the oral administration absorption rate and the biological availability of the glycyrrhizic acid. The method utilizes an ion gelatinization method; sodium tripolyphosphate and sodium carboxymethylcellulose which are used as polyanions, chitosan or quaternary ammonium N-(2-hydroxy) propyl-3-trimethyl ammonium chloride chitosan carry out ion gelatinization reaction; and then, the glycyrrhizic acid ternary complex nanometer particle is prepared through the interaction of the glycyrrhizic acid and the chitosan. The nanometer particle with different particle diameters can be prepared through controlling the molecular weight of the chitosan and the concentration and the ratio of the chitosan (quaternary ammonium N-(2-hydroxy) propyl-3-trimethylammonium chloride) sodium tripolyphosphate, sodium carboxymethylcellulose and the glycyrrhizic acid. The glycyrrhizic acid nanometer particle has controllable diameters and uniform size. The surfaces of the nanometer particles are charged with positive electric charges, and are favorable for the surface modification. Glycyrrhizic acid ternary complex nanometer particle has the advantages of simple and easy implementation of the method, easy acquirement of raw materials, good repetitiveness of preparation processes, strong practicability and wide application.
The CBT is a SAD-tailored version of Beck et al.'s (1979) cognitive therapy for depression called "Coping with the Seasons" (Rohan, 2008). The rationale addresses environmental changes, thoughts, and behaviors in SAD onset and maintenance. It seeks to change behaviors and thoughts to improve coping with winter. Behaviors that promote enjoyment in the winter are increased. Negative thoughts that interfere with self-esteem and negative thoughts about winter are identified and addressed. A relapse-prevention component addresses early identification of negative anticipatory thoughts about winter and SAD-related behavior changes, using the CBT skills learned to cope with subsequent winter seasons, and development of a personalized relapse-prevention plan. The CBT sessions are administered twice a week over 6 weeks (total of 12 sessions) with 4-8 participants per group. The CBT is led by one of three licensed Ph.D.-level psychologists working on the project.
DUVYZAT can cause dose-related thrombocytopenia and other signs of myelosuppression, including decreased hemoglobin and neutropenia. 

In Study 1 [see Clinical Studies (14)], thrombocytopenia occurred in 33% of patients treated with DUVYZAT compared to no patients on placebo. The maximum decrease in platelets occurred within the first 2 months of therapy and remained low throughout the course of therapy. In a few patients, thrombocytopenia was associated with bleeding events including epistaxis, hematoma or contusions. Low platelet counts resulted in DUVYZAT dose reduction in 28% of patients. Patients with baseline platelet counts below the lower limit of normal were excluded from the study.

Decreased hemoglobin and decreased neutrophils were also observed in patients treated with DUVYZAT compared to placebo.

Monitor blood counts every 2 weeks for the first 2 months of treatment, then monthly for the first 3 months, and every 3 months thereafter. Modify the dosage of DUVYZAT for confirmed thrombocytopenia [see Dosage and Administration (2.3)]. Treatment should be permanently discontinued if the abnormalities worsen despite dose modification. If a patient develops signs or symptoms of thrombocytopenia, obtain a platelet count as soon as possible, and hold dosing until platelet count is confirmed.
HIV positive adolescents who initiated care, but did not follow up with care within 12 months of the initial care visit. Also included in this group are those who initiated and followed-up with care, but have dropped out of care for 12 or more months.
Participants assigned to the CBTI treatment group will receive 8 weeks of weekly telehealth sessions with a masters-level therapist. Each session is approximately 50 minutes in duration.
The present invention provides a skin external preparation composition containing hesperetin as an active ingredient. Also, the present invention provides a composition for external use for skin comprising hesperetin and EGCG. Also disclosed is an external skin preparation composition containing a citrus peel extract containing hesperetin as an active ingredient. Also disclosed is a composition for external application to the skin, which contains a green tea extract containing EGCG, in a citrus peel extract containing hesperetin. The composition of the present invention has an excellent antioxidant effect and is useful as a cosmetic composition, a pharmaceutical or a health food composition. The composition of the present invention also has excellent effects of preventing skin erythema, improving skin color, and preventing skin aging.
Ustekinumab is approved for dosing in patients with psoriasis and golimumab is approved for dosing in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. This study will use either drug in patients with chronic sarcoidosis. Ustekinumab and golimumab are being tested to see if they may be useful in treating chronic sarcoidosis. This study will compare the effects (both good and bad) of ustekinumab and golimumab to those of placebo. The purpose of this study is to evaluate the safety and effectiveness of ustekinumab and golimumab (administered as individual treatments) in patients with chronic sarcoidosis with lung and/or skin involvement who still have symptoms even though receiving current therapy. About 180 patients will take part in the study. While in this study, patients may not take part in any other medical research studies. Ustekinumab and golimumab are not approved by the national health authorities for treatment of chronic sarcoidosis; therefore, they can only be used in a research setting to treat this condition. The screening phase of the study, where the doctor will determine if a patient is eligible for the study, will last 1 to 4 weeks. Patients are put into 1 of 3 groups and each group will get a different treatment. The results of the golimumab group and the ustekinumab group are compared to placebo. Patients will either receive ustekinumab, golimumab or placebo. Placebo looks like ustekinumab and golimumab and is given in the same way, by injection, but contains no active drug. Patients will receive study agent until Week 24 and will continue to be followed through Week 44 for assessment of safety and any other effects after discontinuation of therapy. The patient will continue to take all sarcoidosis medication(s) at current, stable dose for the first part of the study. If the patient remained on a stable steroid dose from Week 0 through Week 16 of the study, the study doctor will begin to taper (lower) the steroid dose. The steroid taper will continue through to the end of the Week 28 visit. The patient will continue to take their other sarcoidosis medication(s) at the same dose for the rest of the study. An independent Data Monitoring Committee will be responsible for reviewing the safety data for the study. Patients will be in the study for about 48 weeks. The end of the study is defined as the last visit of the last patient. A site-specific substudy is being implemented to collect serum and lung samples from patients who are currently enrolled in this study. A separate protocol is being implemented to collect lung fluid and serum samples from normal, healthy subjects to be used as comparators for similar samples obtained in the 1275148SCD2001 substudy. Patients will be randomly assigned to 1 of 3 treatment groups: ustekinumab (180 mg at Week 0, followed by 90 mg at Weeks 8, 16, and 24 with placebo at Weeks 4, 12, and 20), golimumab (200 mg at Week 0, followed by 100 mg at Weeks 4, 8, 12, 16, 20, and 24) or placebo (at Weeks 0, 4, 8, 12, 16, 20, and 24) administered by SC injection.
The present invention relates to a pharmaceutical composition for preventing or treating cancer. The present invention relates to polyethylene glycol-polycaprolactone copolymer micelles encapsulated with docetaxel and osthol and a use thereof. More specifically, docetaxel and osthol, which are poorly water-soluble drugs, are encapsulated in a specific polymer to form micelles to improve solubility in water. The pharmaceutical composition for cancer treatment according to the present invention can significantly lower the content of docetaxel by combining docetaxel with ostol at a specific molar ratio, thereby preventing various side effects caused by excessive use of docetaxel and overcoming the problem of drug resistance due to long-term use of docetaxel. In addition, since the composition of the present invention can effectively solubilize docetaxel and osthol by encapsulating a poorly soluble drug in micelles using a polyethylene glycol-polycaprolactone copolymer polymer, the composition can be usefully used as an intravenous injection. Intravenous injection can avoid the hepatic first pass effect compared to oral dosage forms, thereby reducing unnecessary drug loss. Compared to oral dosage forms, bioavailability can also be increased, so the present invention is an effective administration method that can expect high effects with the same amount of drug. The development of such a formulation enables effective administration of docetaxel and osthol.