Abstract: The present invention is related to a pharmaceutical composition and health food for preventing or treating hearing loss, wherein the pharmaceutical composition and health food contain carbenoxolone or its pharmaceutically acceptable salts as an effective component. More particularly, a composition including carbenoxolone or its pharmaceutically acceptable salts as an effective component is provided as a pharmaceutical composition for preventing or treating ototoxic hearing loss due to the carbenoxolone or its pharmaceutically acceptable salts prevent damages on auditory cells from ototoxic drugs such as cisplatin anticancer drugs, and the composition may be used as a drug for treating noise-induced hearing loss and age-related hearing loss, as well as ototoxic hearing loss.

Abstract: A method of contraception in a female is provided. The method includes administering to the female daily for a first number of successive days an oral combination drug formulation of a progestin and an estrogen. The oral combination drug formulation is administered in a multiphasic dosing regimen comprising a second number of phases with duration of each phase is a third number of days. The doses of each of the progestin and estrogen in each subsequent phase of the regimen increase by a predefined dose increment as compared to the corresponding doses of the progestin and estrogen administered during immediately preceding phase of the regimen. The ratio of a daily dose of progestin to a daily dose of estrogen is maintained at a constant level during the entire dosing period. The first number of successive days period is followed by a fourth number of days without progestin and estrogen administration.

Abstract: The present invention is directed to stable pharmaceutical formulations. More specifically, the present invention is directed to stable pharmaceutical formulations of testosterone undecanoate.

Abstract: The invention relates to compositions and methods for treating eye diseases and disorders. More specifically, the invention provides compositions comprising progesterone and methods of treating ocular surface diseases and disorders comprising applying such compositions topically.

Abstract: Embodiments disclosed herein provide compositions and methods for treating lymphangioleiomyomatosis (LAM) comprising inhibiting COX overexpression and prostaglandin over production by administering at least one COX inhibitor and/or prostaglandin biosynthetic pathway inhibitors. Lymphangioleiomyomatosis (LAM) is a rare lung disease. Some LAM occurances are associated with mutations in the tuberous sclerosis complex (TSC) locus. LAM occurs almost exclusively in women, usually of childbearing age.

Abstract: Oral dosage forms of osteoclast inhibitors, such as nitrogen-containing bisphosphonates, such as zoledronic acid in an acid or a salt form, or in a molecular complex can be used to treat or alleviate pain or related conditions.

Abstract: A composition for treating inflammation and pain, including a hydrogen-generating compound in an amount that increases the amount of hydrogen in an individual and has an anti-inflammatory effect. A composition for treating inflammation and pain, including synergistically effective amounts of pregabalin and lactulose. A method of treating inflammation and pain, by administering a composition comprising a hydrogen-generating compound to an individual in an amount that increases the amount of hydrogen in the individual and has an anti-inflammatory effect.

Abstract: The present invention relates, in part, to a composition comprising a multicationic drug and an organic multianion. In some embodiments, the multicationic drug is enclosed within a carrier. In some embodiments, the carrier is a liposome. In some embodiments, the multicationic drug and organic multianion are enclosed within a carrier, while in other embodiments, the multicationic drug is enclosed within the carrier and the organic multianion is outside the carrier. The present invention also relates, in part, to a method of treating a subject for pulmonary distress comprising administering to a subject in need thereof the aforementioned composition.

Abstract: Compositions and methods of utilizing the same are provided for treating bacterial infections. The compositions comprise acidified nitrite in combination with an iron chelator and an antibiotic. The compositions of the present invention are effective at treating bacterial infections with minimal to no side effects. Surprisingly, the combination of these three agents has a synergistic effect, which advantageously permits a lower dose of one or more of the active agents (e.g., the antibiotic).

Abstract: Methods of treating, preventing and/or managing myelodysplastic syndromes are disclosed. Specific methods encompass the administrations of 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidin-2,6-dione in combination with 5-azacytidine.

Abstract: Provided herein are compositions and formulations comprising S-adenosyl-L-methionine (“SAM-e” or “SAMe”) and one or more gallic acid esters. Also provided herein are methods for improving the delivery of SAMe. Compositions and formulations provided herein increase SAMe plasma concentrations and area under the curve (AUC) values. Also provided herein are methods of treating a disease or disorder in a subject by administering compositions or formulations comprising exogenous SAMe and one or more gallic acid esters.

Abstract: Compositions containing conjugates of heparosan polymer with at least one drug are disclosed, along with methods of production and use thereof.

Abstract: The present invention comprises chitosan materials and methods of using carbonic acid for aqueous solubilization of neutralized or pre-treated chitosan gels and provides, among other things, substantially acid salt free composition native final forms without requiring subsequent acid salt elution. The invention includes chitosan-based solid and semi-solid material forms, optionally reinforced with chitosan fibers, such as powders, fibers, films, matrices, sponges, implants, scaffolds, fillers, and hydrogels. Native final forms are produced from chitosan powder solubilized in an aqueous acidic solution, processed to form a high pH hydrated chitosan gel precipitate material that is then neutralized by water washing and re-solubilized substantially to chitosan solution using carbonic acid.

Abstract: The invention features extracorporeal methods for the treatment of a subject having a pregnancy related hypertensive disorder, such as pre-eclampsia or eclampsia. The invention also features devices used for the extracorporeal treatment of subjects have a pregnancy related hypertensive disorder, such as pre-eclampsia or eclampsia.

Abstract: The present invention generally relates to methods of treating hypertension (HTN) in patients in need thereof wherein the patient optionally further suffers from chronic kidney disease (CKD) or Type II diabetes mellitus (T2DM). The invention also relates to methods of treating hyperkalemia in a patient in need thereof, wherein the patient suffers from CKD, T2DM or HTN and are optionally being treated with an effective amount of a renin-angiotensin-aldosterone system (RAAS) agent. The invention also relates to methods of treating kidney disease in a patient in need thereof, wherein the patient is optionally being treated with an effective amount of a renin-angiotensin-aldosterone system (RAAS) agent. The methods can comprise administering an effective amount of a potassium-binding agent to the patient to lower the patient's blood pressure and/or increase or stabilize the patient's kidney function.

Abstract: Non-natural oligomers have recently shown promise as functional analogs of lung surfactant proteins B and C (SP-B and SP-C), two helical and amphiphilic proteins that are critical for normal respiration. The generation of non-natural mimics of SP-B and SP-C has previously been restricted to step-by-step, sequence-specific synthesis, which results in discrete oligomers that are intended to manifest specific structural attributes. Presented herein an alternative approach to SP-B mimicry that is based on sequence-random copolymers containing cationic and lipophilic subunits. These materials, members of the nylon-3 family, are prepared by ring-opening polymerization of ?-lactams. The best of the nylon-3 polymers display promising in vitro surfactant activities in a mixed lipid film. Pulsating bubble surfactometry data indicate that films containing the most surface-active polymers attain adsorptive and dynamic-cycling properties that surpass those of discrete peptides intended to mimic SP-B.

Abstract: Pharmaceutical compositions for and methods of treating an animal, including a human, and methods of preparing such compositions. The pharmaceutical compositions contain crosslinked amine polymers and may be used, for example, to treat diseases or other metabolic conditions in which removal of protons and/or chloride ions from the gastrointestinal tract would provide physiological benefits such as normalizing serum bicarbonate concentrations and the blood pH in an animal, including a human.

Abstract: The subject of the invention is an N-sulfonic polyallylamine derivative (NSPAH) with Formula 1, wherein R is —SO3? or —H, and n is an integer from 150 to 15000; an application of the N-sulfonic polyallylamine derivative as a medicine, particularly for prevention and treatment of respiratory tract infections caused by the human metapneumovirus (hMPV), respiratory tract infections caused by the human rhinoviruses (HRV), and infections caused by the influenza A virus; as well as a pharmaceutical composition comprising the N-sulfonic polyallylamine derivative and application thereof.

Abstract: The mixture of un-refined salt and sugar in the manufacture of a medicament employed for treating lax vagina syndrome or colpoxerosis disease in a mammal. Various tests, vaginal smooth muscle contractility test using New Zealand White Rabbit; (Experimental example 1); the effect on the vagina contractility in volunteers by using perinometer (Experimental example 2); and the effect on the colpoxerosis disease in volunteers (Experimental example 3), showed improving effect on the contractility of vagina tissue and colpoxerosis disease. Accordingly, the combination can be useful in treating or preventing lax vagina syndrome or colpoxerosis disease.

Abstract: The present invention provides a stabilized hypohalous acid solution (or formulation thereof), which may be conveniently packaged for sale, or stored for later use on demand. The invention further provides methods of making the stabilized hypohalous acid solutions, as well as methods of use for disinfecting mammalian tissue, including wounds and burns, and treating skin irritations, among other uses.

Abstract: Embodiments of the invention relate to a composition, method and kit for producing galvanic cells upon application of the composition to the skin. In some embodiments, the composition comprises encapsulated half-galvanic cell units (e.g. individual and/or autonomous half-galvanic cell units) having the same ox/red potential (E°), wherein each half-galvanic cell unit comprises metal particles in the range of nano- to micro size or a mixture thereof, suspended within an aqueous solution of soluble electrolytic salt of same metal and wherein each half-galvanic cell unit is encapsulated by internal layer(s) made of hydrophilic metal (including silicon) oxide nanoparticles and external layer(s) made of hydrophobic metal (including silicon) oxide nanoparticles. The composition is useful for preventing and/or treating alopecia or for enhancing hair growth.

Abstract: The invention provides multi-chamber encapsulated cell therapy cartridge devices that are capable of delivering biologically active molecules as well as methods of using these devices.

Abstract: A method of expanding double negative T cells in culture is described. The method comprises (a) providing a starting sample comprising DN T cells or precursors thereof; (b) substantially depleting CD8+ and CD4+ T cells from the starting sample; (c) culturing the sample from step (b) with an immobilized T cell mitogen in a culture medium comprising an agent that can stimulate DN T cell growth (d) washing the cells obtained in step (c) and resuspending in a culture medium comprising the agent without the T cell mitogen; and (e) washing the cells obtained in step (d) and resuspending in a culture medium comprising the agent and a soluble T cell mitogen. The DN T cells obtained by the method are useful in a variety of applications including the treatment of cancer, infectious diseases, graft versus host disease and autoimmune disease.

Abstract: Provided herein are methods of treatment of an individual having amyotrophic lateral sclerosis, comprising administering to the individual a therapeutically effective amount of placental stem cells, e.g., tissue culture surface-adherent placental stem cells (PDACs). In one aspect, provided herein is a method of treating amyotrophic lateral sclerosis (ALS) comprising administering to an individual having ALS a therapeutically effective amount of placental stem cells. In certain embodiments, “therapeutically effective” means an amount effective to reduce or ameliorate one or more symptoms of ALS.

Abstract: Methods are disclosed for treating and preventing gut barrier dysfunction or an illness associated with gut barrier dysfunction in a subject comprising administering to the subject bacterium that produce an indole or an indole metabolite and for identifying compounds and bacteria for use in treatment and prevention of gut barrier dysfunction or an illness associated with gut barrier dysfunction.

Abstract: Provided herein are genetically modified microbes. In one embodiment, a genetically modified microbe includes an exogenous polynucleotide comprising a pheromone-responsive region. In one embodiment, the pheromone-responsive region is derived from a conjugative plasmid from a member of the genus Enterococcus spp. The pheromone-responsive region includes a pheromone-responsive promoter and an operably linked coding region encoding an antimicrobial peptide. In one embodiment, a genetically modified microbe includes an exogenous polynucleotide comprising a promoter and an operably linked coding sequence encoding an antimicrobial peptide, where expression of the coding region is controlled by a modulator polypeptide and is altered by a modulating agent, and where the coding region encodes an antimicrobial peptide. Also provided herein are methods of using the genetically modified microbes, including methods for inhibiting growth of an Enterococcus spp., a pathogenic E. coli, or a pathogenic Salmonella spp.

Abstract: Selected bacterial strains belonging to the genus Bifidobacterium for use in the treatment of hypercholesterolaemia are described. In particular, a food composition or supplement product or medical device or pharmaceutical composition has said bacterial strains in association with sterols or phytosterols and/or stanols or phytostanols and/or glucomannan and/or konjac gum and/or prebiotic fibers and/or fermented red rice and/or betaglucans from oats, oat bran, barley, barley bran and/or aloe arborescens gel in lyophilized form.

Abstract: An embodiment is a method of preventing, mitigating or treating Gastroesophageal Reflux Disease (GERD) that includes administering an effective amount of a medicament comprised of the Lactobacillus bulgaricus B-30892 strain and/or bioactive compounds from its supernatant to a human to prevent, mitigate or treat GERD.

Abstract: A method for manufacturing water-soluble medical amber causes that original great molecular groups of medical amber crystals are decomposed into hydrophilic extracted liquid plentiful of water and having small molecular groups, which can be directly coated on skin without mixing with water and added with grease or oil. The method original performs disinfecting and sterilizing treatment for natural medical amber crystals; after a polishing and cleaning step, they are placed in a bottle with treatment liquid therein for a predetermined time period so that the mixture in the bottle ferments and decomposes into small pieces which presents as cream-like liquid. Then paddies are added into the bottle. The bottle is retained through several months so that the medical amber crystals ferment quickly to form as a liquid composite. Then the bottle is evaporated several hours so that the liquid composite is distilled out of the bottle.

Abstract: The present invention provides a composition for a medicinal or health effect of a treatment of liver fat and body fat, a reduction of blood pressure, an increase of the energy expenditure rate, a reduction of inflammatory C-reactive proteins and a reduction of plasma aminotransferase enzymes, comprising an effective amount of fucoxanthin alone or in combination with pomegranate seed oil, a pharmaceutically acceptable salt, a prodrug thereof, or a salt of the prodrug; and a method of using the same. The fucoxanthin may be used in pure form, or as a component of a brown marine vegetable extract.

Abstract: Pharmaceutical extracts from Egyptian broomrape have proven efficacy against HCV and NAFLD. Compositions and method of making and using same are provided.

Abstract: An anti-aging composition, having anti-oxidant and anti-inflammatory properties, comprised of an effective amount of Turmeric Root Extract, Olive Leaf Extract, Grape Seed Extract, and Rosemary Leaf Extract to regulate and slow the signs of skin aging and tired looking skin. The composition also includes characteristics that may help to prevent cancer. The composition implements liposomal technology, using phosphatidylcholine, to surround the active ingredients with lipid molecules, thereby increasing the bioavailability of the present composition.

Abstract: Methods and products for producing an antigen specific immune response are provided. The methods involve administration of a caspase inhibitor to a subject.

Abstract: The invention provides low-dose formulations of guanylate cyclase-C (“GCC”) agonist peptides and methods for their use. The formulations of the invention can be administered either alone or in combination with one or more additional therapeutic agents, preferably an inhibitor of cGMP-dependent phosphodiesterase or a laxative.

Abstract: The invention provides methods and compositions for use of desmopressin in combination with a 5-alpha reductase inhibitor. The methods and compositions are useful in the treatment of nocturia and other urinary frequency disorders.

Abstract: Provided herein are peptide formulations comprising polymers as stabilizing agents. The peptide formulations can be more stable for prolonged periods of time at temperatures higher than room temperature when formulated with the polymers. The polymers used in the present invention can decrease the degradation of the constituent peptides of the peptide formulations.

Abstract: Provided herein are peptide formulations comprising polymers as stabilizing agents. The peptide formulations can be more stable for prolonged periods of time at temperatures higher than room temperature when formulated with the polymers. The polymers used in the present invention can decrease the degradation of the constituent peptides of the peptide formulations.

Abstract: A method for enhancing wound healing or treating methicillin-resistant Staphylococcus aureus (MRSA) infection in a wound comprising administering a subject in need thereof with a therapeutically effective amount of a tilapia piscidin (TP) is described, wherein the TP is preferably TP3 or TP4.

Abstract: The present invention relates to reconstituted high density lipoprotein (rHDL) formulations comprising an apolipoprotein, a lipid and a lyophilization stabilizer. Said formulations have reduced renal toxicity and good long-term stability, especially in lyophilized form.

Abstract: The present invention provides polypeptide-polymer conjugates. A subject polypeptide-polymer conjugate is useful in a variety of applications, which are also provided.

Abstract: Disclosed herein are methods for treating an angiogenesis-related condition or disease in a subject in need thereof. Said method includes administering to the subject a peptide having at least 90% sequence identity of the sequence of SEQ ID NO: 1 or SEQ ID NO:3 in a therapeutically effective amount.

Abstract: The invention relates to methods for the temporal administration of EDA agonists, in particular EDI200, which correlate to optimal therapeutic response windows required for the formation of any EDA-dependent structures such as ectodermal appendages. Use of the methods described allow for the design of targeted therapeutic dosing and administration regimens in order to correct or alter abnormal phenotypes associated with genetic disorders, in particular, XLHED.

Abstract: Provided herein are combination therapies for the treatment of pathological conditions, such as cancer, using an antagonist of FGFR signaling.

Abstract: The present disclosure provides FGF1 mutant proteins, such as those having an N-terminal deletion, point mutation(s), or combinations thereof, which can reduce blood glucose in a mammal. Such mutant FGF1 proteins can be part of a chimeric protein that includes a ?-Klotho-binding protein, an FGFR1c-binding protein, a ?-Klotho-binding protein and a FGFR1c-binding protein, a C-terminal region from FGF19 or FGF21. In some examples, mutant FGF1 proteins have reduced mitogenic activity. Also provided are nucleic acid molecules that encode such proteins, and vectors and cells that include such nucleic acids. Methods of using the disclosed molecules to reduce blood glucose levels are also provided.

Abstract: The invention relates to variants and fusions of fibroblast growth factor 19 (FGF19), variants and fusions of fibroblast growth factor 21 (FGF21), fusions of FGF19 and/or FGF21, and variants or fusions of FGF19 and/or FG-F21 proteins and peptide sequences (and peptidomimetics), having one or more activities, such as bile acid homeostasis modulating activity, and methods for and uses in treatment of bile acid and other disorders.

Abstract: The present disclosure provides chimeric proteins having an N-terminus coupled to a C-terminus, wherein the N-terminus comprises an N-terminal portion of fibroblast growth factor (FGF) 2 and the C-terminus comprises a portion of an FGF1 protein, wherein the chimeric protein comprises at least 95% sequence identity to SEQ ID NO: 9, 10, 11, 12 or 13. Also provided are nucleic acid molecules that encode such proteins, and vectors and cells that include such nucleic acids. Methods of using the disclosed molecules to reduce blood glucose levels are also provided.

Abstract: A method for treating warts includes administering to a patient with warts a composition having an autologous, matched allogenic, donor tissue source of mixed, hematological, pleuripotent, ISPC derived or harvested or induced mesenchymal type stem cells and/or filgrastim, derivatives, bioequivalents, and pharmaceutically effective salts thereof. Patients include both non-chemotherapy or non-immunosuppressed patients, as well as chemotherapy or immunosupressed patients with warts of non-responsive cutaneous type. The treatment leads to resolution of warts and/or a change in their response to laser therapy or standard treatments previously shown not to be effective.

Abstract: Interleukin-10 (IL-10) conjugated via a linker to one or more polyethylene glycol (PEG) molecules at a single amino acid residue of the IL-10, and a method for preparing the same, are provided. The method produces a stable mono-pegylated IL-10, which retains IL-10 activity, where pegylation is selective for the N-terminus on one subunit of IL-10 with little or no formation of monomeric IL-10. The method also provides a substantially homogenous population of mono-PEG-IL-10.

Abstract: The present application relates to treatment of cutaneous wounds using IL-12. The methods of the invention result in improved wound closure. The methods comprise treating cutaneous wounds using topical, subcutaneous, and/or intramuscular administration of IL-12.

Abstract: The invention features combination therapies using an IL-15-based superagonist complex and an antibody to effectively treat subjects with cancer and infectious diseases.