Provided herein are compositions, systems, and methods for treating a disease, such as kidney and/or cardiovascular disease, with an agent that reduces the production of trimethylamine (TMA) or trimethylamine-n-oxide (TMAO) in a subject. In certain embodiments, the agent is: i) 3,3-dimethyl-1-butanol (DMB) or a DMB derivative or related compound, ii) acetylsalicylic acid or derivative thereof (e.g., with an enteric coating for delivery to the colon and/or cecum); iii) a flavin monooxygenase 3 (FMO3) inhibitor; iv) a gut TMA lyase inhibitor; v) an antibiotic or antimicrobial; vi) a probiotic or prebiotic; vii) an antiplatelet agent; or viii) a TMA and/or TMAO sequestering agent.

A method of diagnosing and/or treating stage 3 or stage 4 chronic kidney disease (CKD) is provided herein, where a proUGN concentration level of 2.241 ng/ml or higher is indicative of stage 3 or stage 4 CKD. Additionally, a method of diagnosing and/or treating pre-CKD is also provided herein, where a proUGN concentration level of 2.05 ng/ml to and including 2.24 ng/ml in a biological sample is indicative of pre-CKD and that a patient is at risk of developing CKD. The methods may comprise measuring the amount of proUGN in a biological sample of the patient and/or administering a CKD-therapeutic agent and/or providing lifestyle and/or dietary modifications to the patient.

A detection method for 305 fertility-associated sperm localization protein expressed in human testis and epididymis. The method includes qualitatively or quantitatively detecting for sperm localization proteins on a sperm or in seminal plasma via capture agents for the sperm localization proteins. The sperm localization proteins belong to an important protein group related to human sperm maturation and fertility. The method provides a diagnostic approach for male infertility.

The present disclosure relates to methods of diagnosing lupus nephritis or proliferative lupus nephritis in a subject, methods of predicting a subject's risk of developing lupus nephritis and methods of determine whether a subject suffering from lupus nephritis is responding to treatment. The methods herein involve detecting the presence of or level of at least one biomarker which is IL-16, Galectin-1, CD163, CD206, FOLR2, proteinase 3, or a combination thereof.

Provided herein are compositions, systems, and methods for treating a disease, such as kidney and/or cardiovascular disease, with an agent that reduces the production of trimethylamine (TMA) or trimethylamine-n-oxide (TMAO) in a subject. In certain embodiments, the agent is: i) 3,3-dimethyl-1-butanol (DMB) or a DMB derivative or related compound, ii) acetylsalicylic acid or derivative thereof (e.g., with an enteric coating for delivery to the colon and/or cecum); iii) a flavin monooxygenase 3 (FMO3) inhibitor; iv) a gut TMA lyase inhibitor; v) an antibiotic or antimicrobial; vi) a probiotic or prebiotic; vii) an antiplatelet agent; or viii) a TMA and/or TMAO sequestering agent.

A method of treating or preventing gonadal or uterine toxicity induced by an agent in a subject is provided. Accordingly there is provided a method comprising administering to a subject a therapeutically effective amount of pigment epithelium-derived factor (PEDF), thereby treating or preventing the gonadal toxicity induced by the agent. Also provided is, a method comprising determining gonadal function in a subject; and administering to the subject a therapeutically effective amount of PEDF, thereby treating or preventing the gonadal toxicity induced by the agent. Also provided is a PEDF for use in the treatment or prevention of gonadal toxicity induced by an agent in a subject. Also provided are cell culture, a medium, a kit and method for improving oocyte quality ex-vivo.

Provided herein are compositions, systems, and methods for treating a disease, such as kidney and/or cardiovascular disease, with an agent that reduces the production of trimethylamine (TMA) or trimethylamine-n-oxide (TMAO) in a subject. In certain embodiments, the agent is: i) 3,3-dimethyl-1-butanol (DMB) or a DMB derivative or related compound, ii) acetylsalicylic acid or derivative thereof (e.g., with an enteric coating for delivery to the colon and/or cecum); iii) a flavin monooxygenase 3 (FMO3) inhibitor; iv) a gut TMA lyase inhibitor; v) an antibiotic or antimicrobial; vi) a probiotic or prebiotic; vii) an antiplatelet agent; or viii) a TMA and/or TMAO sequestering agent.

A kit for assessing efficacy of a vaginal atrophy treatment regimen is disclosed. The kit includes a pretreatment assessment method for vaginal atrophy comprising and a topical treatment for application to the labia majora, labia minora, introitus, vagina, or combinations thereof.

Methods for detecting urogenital conditions or urogenital status in a subject are described comprising measuring urogenital markers or polynucleotides, encoding the markers in a sample from the subject. The invention also provides localization or imaging methods for urogenital conditions, and kits for carrying out the methods of the invention. The invention also contemplates therapeutic applications for urogenital conditions employing urogenital markers, polynucleotides encoding the markers, and/or binding agents for the markers.

The present invention relates to systems, kits, and methods for identifying subjects with increased levels (e.g., in a urine sample) of at least two urine metabolites selected from: butanal; 2-Hydroxy-1,3-dimethoxy-8,9-methylenedioxycoumestan; 6-Methylmercaptopurine; Dimethyl-L-arginine; N-butanoyl-lhomoserine lactone; Hexanoylglycine; Methyl propenyl ketone; Ferulate; 2-Oxoarginine; and 2-Hydroxyestradiol-3-methyl ether, as well as methods of determining if a subject has or is at risk of urinary stone disease based on such urine metabolites. In certain embodiments, the urinary tract of a subject with elevated levels of at least two of the urine metabolites is imaged (e.g., to generate an image showing the size, location, or number of urinary stones present).