Provided herein are methods for detecting neutralizing antibodies to leptins, including metreleptin, as well as identifying subjects having such neutralizing antibodies.

A method is disclosed for predicting in advance whether a melanoma patient is likely to benefit from high dose IL2 therapy in treatment of the cancer. The method makes use of mass spectrometry data obtained from a blood-based sample of the patient and a computer configured as a classifier and making use of a reference set of mass spectral data obtained from a development set of blood-based samples from other melanoma patients. A variety of classifiers for making this prediction are disclosed, including a classifier developed from a set of blood-based samples obtained from melanoma patients treated with high dose IL2 as well as melanoma patients treated with an anti-PD-1 immunotherapy drug. The classifiers developed from anti-PD-1 and IL2 patient sample cohorts can also be used in combination to guide treatment of a melanoma patient.

Provided are methods for determining the amount of thyroglobulin in a sample using various purification steps followed by mass spectrometry. The methods generally involve purifying thyroglobulin in a test sample, digesting thyroglobulin to form peptide T129, purifying peptide T129, ionizing peptide T129, detecting the amount of peptide T129 ion generated, and relating the amount of peptide T129 ion to the amount of thyroglobulin originally present in the sample.

In certain embodiments, the present invention provides a method of treating or preventing lupus (e.g., SLE) in a subject, comprising: (a) identifying the subject as having at least one differentially regulated biomarker selected from CD40, CD40L, CD86, CD80, and PD1; and (b) administering an agent that inhibits the CD40 or CD28 signaling pathway, thereby treating or preventing lupus in the subject. In other embodiments, the present invention provides a method of treating or preventing lupus (e.g., SLE) in a subject, comprising: (a) administering an agent that inhibits the CD40 or CD28 signaling pathway; (b) determining whether the agent neutralizes at least one differentially regulated biomarker selected from CD40, CD40L, CD86, CD80, and PD1; and (c) adjusting the dosing of the agent in the subject, thereby treating or preventing lupus in the subject.

The invention provides novel compositions and methods for the treatment of Radiation-Induced Bystander Effects (RIBE), resulting from radiation exposure. In one preferred embodiment the inventions includes novel therapeutic agents, including but not limited to quercetin and quercetin analogs, as well as E64, CA074, CA074Me, that interfere with the activity of Cathepsin B.

A method of predicting a sepsis condition in a subject, comprising: a. determining a level of a biomarker in a sample of said subject, wherein the biomarker is of structure (I): Formula (I) or a salt thereof; and b. comparing said level to a predetermined reference value of the biomarker, wherein an elevated biomarker level is indicative of the risk of the sepsis condition.

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The inventors assessed in locally advanced rectal cancer whether a diagnostic biopsy-adapted Immunoscore (ISg) could predict response to neoadjuvant treatment (nT) and better define patients eligible to an organ preservation strategy (“Watch-and-Wait”). The inventors showed that IS.sub.B was an independent parameter, more informative than pre- (P<0.001) and post-nT (P<0.05) imaging to predict disease-free survival. IS.sub.B combined with imaging post-nT discriminated very good responders that could benefit from organ preservation strategy. Accordingly, the present invention relates to methods for predicting the recurrence and/or death of patients suffering from a solid cancer after preoperative adjuvant therapies.

Increased levels of soluble urokinase-type plasminogen activator receptor (suPAR), particularly a plasma level of over 4.75 ng/ml or 6 ng/nl, have been found to be a predictor of whether a subject with COVID-19 symptoms and/or SARS-CoV-2 infection will require oxygen supplementation.

The present invention relates to use of PAK4 and CRTC1 or the treatment or diagnosis of a degenerative brain disease. Specifically, the present invention relates to a pharmaceutical composition for the prevention or treatment of a degenerative brain disease comprising PAK4 (p21-activated kinase 4) or a PAK4 activator as an effective ingredient. In addition, the present invention relates to a pharmaceutical composition for the prevention or treatment of a degenerative brain disease comprising a CRTC1 expression enhancer or activator as an effective ingredient, a diagnostic kit for a degenerative brain disease comprising an agent for detecting CRTC1, and a method for screening a substance for the prevention or treatment of a degenerative brain disease, comprising (a) applying a candidate drug to brain tissue or brain cells containing CRTC1 gene or CRTC1 protein; (b) measuring the degree of phosphorylation in CRTC1; and (c) determining the candidate drug as a substance for the prevention or treatment of a degenerative brain disease when the measurement in step (b) indicates that the phosphorylation in CRTC1 is increased.

The present disclosure provides treatment modalities, e.g., strategies, treatment methods, patient stratification methods, combinations, and compositions that are useful for the treatment of disorders, e.g., proliferative disorders, such as certain cancer. Some aspects of this disclosure provide treatment modalities, methods, strategies, compositions, combinations, and dosage forms for the treatment of cell proliferative disorders, e.g., cancers with decreased activity or function, or loss of function, of SMARCA4 with a SMARCA2 antagonist.