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FDA Grants Genentech’s Tecentriq in Combination With Abraxane Accelerated Approval for People With PD-L1-Positive, Metastatic Triple-Negative Breast Cancer
https://www.marketwatch.com/press-release/fda-grants-genentechs-tecentriq-in-combination-with-abraxane-accelerated-approval-for-people-with-pd-l1-positive-metastatic-triple-negative-breast-cancer-2019-03-08

Mar 7th, 2019 - Genentech, a member of the Roche Group (six:RO)(six:ROG)(otcqx:RHHBY), today announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Tecentriq [®] (atezolizumab) plus chemotherapy (Abraxane [®] [paclitaxel protein-bound particles for injectable suspension (albumin-bound); nab-paclitaxel]) for the treatment of adults with unresectable locally advanced or metasta...

Microvascular Complications and Foot Care: Standards of Medical Care in Diabetes—2019
http://care.diabetesjournals.org/content/42/Supplement_1/S124

Dec 17th, 2018 - Chronic kidney disease (CKD) is diagnosed by the persistent presence of elevated urinary albumin excretion (albuminuria), low estimated glomerular filtration rate (eGFR), or other manifestations of kidney damage (1,2). In this section, the focus will be on CKD attributed to diabetes (diabetic kidney disease), which occurs in 20–40% of patients with diabetes (1,3–5). CKD typically develops after...

Atezolizumab and Nab-Paclitaxel in Advanced Triple-Negative Breast Cancer
https://www.nejm.org/doi/10.1056/NEJMoa1809615
Schmid, P. et. al.

Nov 28th, 2018 - Unresectable locally advanced or metastatic triple-negative (hormone-receptor–negative and human epidermal growth factor receptor 2 [HER2]–negative) breast cancer is an aggressive disease with poor outcomes. Nanoparticle albumin-bound (nab)–paclitaxel may enhance the anticancer activity of atezolizumab. IMpassion130

Home Use Tests
https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/HomeUseTests/default.htm

Sep 26th, 2018 - Home use tests allow you to test for some diseases or conditions at home. These tests are cost-effective, quick, and confidential. Home use tests can help: detect possible health conditions when you have no symptoms, so that you can get early treatment and lower your chance of developing later complications (i.e. cholesterol testing, hepatitis testing). detect specific conditions when there...

Liver Structure and Function - Hepatic and Biliary Disorders - Merck Manuals Professional Edition
https://www.merckmanuals.com/professional/hepatic-and-biliary-disorders/approach-to-the-patient-with-liver-disease/liver-structure-and-function

Jan 1st, 2018 - The liver is the most metabolically complex organ. Hepatocytes (liver parenchymal cells) perform the liver’s metabolic functions: Formation and excretion of bile during bilirubin metabolism (see Overview of Bilirubin Metabolism) Regulation of carbohydrate homeostasis Lipid synthesis and secretion of plasma lipoproteins Control of cholesterol metabolism Formation of urea, serum albumin, c...

ACG Clinical Guideline: Evaluation of Abnormal Liver Chemistries
https://journals.lww.com/ajg/pages/articleviewer.aspx?year=2017&issue=01000&article=00013&type=Fulltext
The American Journal of Gastroenterology; Kwo, P. et. al.

Jun 30th, 2017 - Clinicians are required to assess abnormal liver chemistries on a daily basis. The most common liver chemistries ordered are serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase and bilirubin. These tests should be termed liver chemistries or liver tests. Hepatocellular injury is defined as disproportionate elevation of AST and ALT levels compared with al...

Practical Approach to Detection and Management of Chronic Kidney Disease for the Primary Care Clinician
https://www.amjmed.com/article/S0002-9343(15)00855-4/pdf
The American Journal of Medicine; Vassalotti, J. et. al.

Feb 1st, 2016 - A panel of internists and nephrologists developed this practical approach for the Kidney Disease Outcomes Quality Initiative to guide assessment and care of chronic kidney disease (CKD) by primary care clinicians. Chronic kidney disease is defined as a glomerular filtration rate (GFR) <60 mL/min/1.73 m2 and/or markers of kidney damage for at least 3 months. In clinical practice the most comm...

ACE Inhibitors and Statins in Adolescents with Type 1 Diabetes.
https://doi.org/10.1056/NEJMoa1703518
The New England Journal of Medicine; Marcovecchio ML, Chiesa ST et. al.

Nov 1st, 2017 - Among adolescents with type 1 diabetes, rapid increases in albumin excretion during puberty precede the development of microalbuminuria and macroalbuminuria, long-term risk factors for renal and cardiovascular disease. We hypothesized that adolescents with high levels of albumin excretion might benefit from angiotensin-converting-enzyme (ACE) inhibitors and statins, drugs that have not been ful...

Risk of Autism Associated With Hyperbilirubinemia and Phototherapy.
https://doi.org/10.1542/peds.2016-1813
Pediatrics Wu YW, Kuzniewicz MW et. al.

Sep 27th, 2016 - Whether neonatal hyperbilirubinemia and/or phototherapy increase the risk of autism spectrum disorder (ASD) is unclear. We sought to quantify the risk of ASD associated with elevated total serum bilirubin (TSB) levels and with phototherapy. In a retrospective cohort study of 525 409 infants born at ≥35 weeks' gestation in 15 Kaiser Permanente Northern California (KPNC) hospitals, 1995-2011, we ...

Utility of Decision Rules for Transcutaneous Bilirubin Measurements.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4845868
Pediatrics Taylor JA, Burgos AE et. al.

May 31st, 2016 - Transcutaneous bilirubin (TcB) meters are widely used for screening newborns for jaundice, with a total serum bilirubin (TSB) measurement indicated when the TcB value is classified as "positive" by using a decision rule. The goal of our study was to assess the clinical utility of 3 recommended TcB screening decision rules. Paired TcB/TSB measurements were collected at 34 newborn nursery sites. ...

Association Between Laboratory Calibration of a Serum Bilirubin Assay, Neonatal Bilirub...
https://doi.org/10.1001/jamapediatrics.2015.4944
JAMA Pediatrics; Kuzniewicz MW, Greene DN et. al.

Apr 11th, 2016 - The American Academy of Pediatrics treatment recommendations for neonatal jaundice are based on age-specific total serum bilirubin (TSB) levels. In May 2012, Ortho Clinical Diagnostics adjusted the calibrator values for Vitros Chemistry Products BuBc Slides (Ortho Clinical Diagnostics), a widely used method to quantify TSB, after concerns of positively biased results. To investigate the associa...

Diagnosing Jaundice by Eye-Outpatient Assessment of Conjunctival Icterus in the Newborn.
https://doi.org/10.1016/j.jpeds.2016.01.032
The Journal of Pediatrics; Maisels MJ, Coffey MP et. al.

Feb 23rd, 2016 - In pediatric office practices, we compared transcutaneous bilirubin levels in 689 newborns, age 3-10 days, with and without conjunctival icterus. In this age range, and in the absence of other clinical or laboratory indications, the presence of conjunctival icterus does not imply the need to measure the transcutaneous bilirubin or serum bilirubin level, but the absence of conjunctival icterus h...

Long-acting recombinant coagulation factor IX albumin fusion protein (rIX-FP) in hemoph...
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4825413
Blood Santagostino E, Martinowitz U et. al.

Jan 12th, 2016 - A global phase 3 study evaluated the pharmacokinetics, efficacy, and safety of recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP) in 63 previously treated male patients (12-61 years) with severe hemophilia B (factor IX [FIX] activity ≤2%). The study included 2 groups: group 1 patients received routine prophylaxis once every 7 days for 26 weeks, followed by either 7-,...

A Randomized Trial of Phototherapy with Filtered Sunlight in African Neonates.
https://doi.org/10.1056/NEJMoa1501074
The New England Journal of Medicine; Slusher TM, Olusanya BO et. al.

Sep 16th, 2015 - Sequelae of severe neonatal hyperbilirubinemia constitute a substantial disease burden in areas where effective conventional phototherapy is unavailable. We previously found that the use of filtered sunlight for the purpose of phototherapy is a safe and efficacious method for reducing total bilirubin. However, its relative safety and efficacy as compared with conventional phototherapy are unkno...

Intravenous immunoglobulin treatment for secondary recurrent miscarriage: a randomised,...
https://doi.org/10.1111/1471-0528.13192
BJOG : an International Journal of Obstetrics and Gynaecology; Christiansen OB, Larsen EC et. al.

Nov 21st, 2014 - To determine whether infusions with intravenous immunoglobulin (IVIg) during early pregnancy increase live birth rate in women with secondary recurrent miscarriage compared with placebo. A single-centre, randomised, double-blind, placebo-controlled trial. A tertiary centre for recurrent miscarriage in Copenhagen, Denmark. A group of 82 women with unexplained secondary recurrent miscarriage and ...

Levels of alkaline phosphatase and bilirubin are surrogate end points of outcomes of pa...
https://doi.org/10.1053/j.gastro.2014.08.029
Gastroenterology Lammers WJ, van Buuren HR et. al.

Aug 27th, 2014 - Noninvasive surrogate end points of long-term outcomes of patients with primary biliary cirrhosis (PBC) are needed to monitor disease progression and evaluate potential treatments. We performed a meta-analysis of individual patient data from cohort studies to evaluate whether patients' levels of alkaline phosphatase and bilirubin correlate with their outcomes and can be used as surrogate end po...

Initial cholecystectomy vs sequential common duct endoscopic assessment and subsequent ...
https://doi.org/10.1001/jama.2014.7587
JAMA Iranmanesh P, Frossard JL et. al.

Jul 9th, 2014 - The optimal management of treatment for patients at intermediate risk of a common duct stone (including increased liver function tests but bilirubin <4 mg/dL and no cholangitis) is a matter of debate. Many stones migrate spontaneously into the duodenum, making preoperative common duct investigations unnecessary. To compare strategies of cholecystectomy first vs a sequential endoscopic common du...

Incidence, presentation, and outcomes in patients with drug-induced liver injury in the...
https://doi.org/10.1053/j.gastro.2013.02.006
Gastroenterology Björnsson ES, Bergmann OM et. al.

Feb 19th, 2013 - Little is known about the incidence of drug-induced liver injury (DILI) in the general population. We investigated the incidence and the quantitative risk of DILI in a population-based cohort. We performed a prospective study and collected data from 96 individuals diagnosed with DILI in Iceland from 2010 through 2011 (54 women; median age, 55 y). Liver injury was defined based on levels of alan...

Evaluation of Home Phototherapy for Neonatal Hyperbilirubinemia.
https://doi.org/10.1016/j.jpeds.2020.01.004
The Journal of Pediatrics; Chang PW, Waite WM

Feb 13th, 2020 - To characterize home phototherapy treatment for neonatal hyperbilirubinemia and assess the risk factors associated with the need for hospital admission during or after home phototherapy. This was a retrospective study of newborn infants born at ≥35 weeks of gestation who underwent comprehensive home phototherapy (that included daily in-home lactation support and blood draws) over an 18-month pe...

Hepatitis Flares Are Associated With Better Outcomes Than No Flare in Patients With Dec...
https://doi.org/10.1016/j.cgh.2020.01.018
Clinical Gastroenterology and Hepatology : the Official Clinical Practice Journal of the American Gastroenterological Association; Chang ML, Cheng JS et. al.

Jan 26th, 2020 - Little is known about the effects of baseline hepatitis flares (level of alanine aminotransferase ≥5-fold above the upper limit of normal) on the outcomes of patients with chronic hepatitis B virus (HBV) infection with decompensated cirrhosis treated with nucleos(t)ide analogues. We aimed to investigate these effects. We performed a cohort study of 511 consecutive patients (78.1% men; 58.7% wit...