Tue, 20 Jun 2017 12:00:00 EDT Białystok PLUS - Polish Longitudinal University Study Conditions: Cardiovascular Diseases; Diabetes; Neuro-Degenerative Disease; Obesity; Pulmonary Disease; Neoplastic Disease Intervention: Other: Discover of novel risk factors. Sponsors: Medical University of Bialystok; University Medicine Greifswald; City of Białystok; Marshall’s Office of Podlaskie Voivodship Enrolling by invitation - verified June 2017
Tue, 20 Jun 2017 12:00:00 EDT Characterization of Heart Failure With Preserved Ejection Fraction Condition: Fibrosis Estimated by cMR Ant Biomarkers Interventions: Diagnostic Test: cMR; Biological: biomarker Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain Recruiting - verified June 2017
Tue, 20 Jun 2017 12:00:00 EDT Corazon de la Familia (Heart of the Family) Conditions: Risk Reduction Behavior; Diabetes Mellitus, Type 2; Cardiovascular Diseases Interventions: Behavioral: Family-focused intervention arm; Behavioral: Individual-focused intervention arm Sponsors: University of Kentucky; National Institute of Nursing Research (NINR); National Institutes of Health (NIH) Not yet recruiting - verified June 2017
Tue, 20 Jun 2017 12:00:00 EDT Creating Healthy Environments for Chicago Kids Condition: Childhood Obesity Intervention: Behavioral: Family-based pediatric obesity treatment Sponsors: Rush University Medical Center; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Not yet recruiting - verified June 2017
Tue, 20 Jun 2017 12:00:00 EDT Novel PET/CT and Treatment Strategies to Reduce PTS Following DVT Conditions: Deep Venous Thrombosis; Post-thrombotic Syndrome Intervention: Device: PET/CT Sponsor: Massachusetts General Hospital Not yet recruiting - verified June 2017
Tue, 20 Jun 2017 12:00:00 EDT Association Between Insulin Resistance and Beta Cell Function With HbA1C in Diabetics Condition: Diabetes Mellitus, Type 2 Interventions: Diagnostic Test: Fasting insulin level; Diagnostic Test: Plasma drug level Sponsors: Clinical Research Centre, Malaysia; Ministry of Health, Malaysia Not yet recruiting - verified June 2017
Mon, 19 Jun 2017 12:00:00 EDT Effects of Sequential Treatment Based on Lina/MET After Short-term Intensive Insulin in Newly Diagnosed Type 2 Diabetes Condition: Type 2 Diabetes Mellitus Interventions: Drug: CSII followed by Lina+MET; Drug: CSII followed by Lina; Drug: CSII followed by MET; Drug: CSII alone Sponsors: Sun Yat-sen University; Nanfang Hospital of Southern Medical University; Guangdong General Hospital; Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University; Zhujiang Hospital; Guangzhou First People's Hospital; The Third Affiliated Hospital of Guangzhou Medical University; The Third Affiliated Hospital of Southern Medical University; Guangdong Provincial Hospital of Traditional Chinese Medicine Not yet recruiting - verified June 2017
FDA (Food and Drug Administration) press releases. FDA makes sure of the safety of all medicines which can be injected, breathed in, rubbed in and swallowed, in the United States of America.
Mon, 26 Jun 2017 20:06:00 -0400 FDA approves first subcutaneous C1 Esterase Inhibitor to treat rare genetic disease The U.S. Food and Drug Administration today approved Haegarda, the first C1 Esterase Inhibitor (Human) for subcutaneous (under the skin) administration to prevent Hereditary Angioedema (HAE) attacks in adolescent and adult patients. The subcutaneous route of administration allows for easier at-home self-injection by the patient or caregiver, once proper training is received.
Thu, 22 Jun 2017 17:15:00 -0400 U.S. Marshals seize adulterated food from a Minnesota warehouse The U.S. Food and Drug Administration announced that on June 15, the U.S. Marshals Service seized food products held at Professional Warehouse and Distribution, Inc., in St. Paul, Minnesota. The food products seized are worth approximately $73,000 and include, among other things, barley flour, spices, pasta, dried beans, tea and cookies.
Tue, 20 Jun 2017 13:24:00 -0400 Statement from FDA Commissioner Scott Gottlieb, M.D., on the 2016 National Youth Tobacco Survey results While the latest numbers from the 2016 National Youth Tobacco Survey are encouraging, it is critical that we work to ensure this downward trend continues over the long term across all tobacco products.
Every day in the U.S., more than 2,500 youth under the age of 18 smoke their first cigarette and more than 400 youth become daily cigarette smokers. It is also clear from these most recent numbers that youth are continuing to experiment with, or becoming regular users of, a wide range of other tobacco products.
Thu, 15 Jun 2017 13:49:00 -0400 Sonar Products ordered to cease operations, Stratus Pharmaceuticals ordered to cease distributing unapproved drugs Today, U.S. District Judge Kathleen M. Williams for the Southern District of Florida entered a consent decree of permanent injunction between the United States and Stratus Pharmaceuticals Inc. of Miami, Florida, Sonar Products Inc. of Carlstadt, New Jersey and two of the companies’ officers, Alberto Hoyo and Juan Carlos Billoch.
Thu, 15 Jun 2017 12:33:00 -0400 Statement from FDA Commissioner Scott Gottlieb, M.D. – FDA is taking new steps to help assess opioid drugs with abuse-deterrent properties Last month, I asked my colleagues at the FDA to identify what additional and more forceful steps the FDA can take, on top of the vigorous work the agency is already doing, to address the crisis of opioid addiction. Everyone at the FDA is committed to focusing on all aspects of the epidemic. The new policy steps that we announced included the formation of a steering committee to examine additional regulatory and policy actions that we can take to combat this crisis. This steering committee will place particular emphasis on evaluating efforts we can take to reduce the number of new cases of addiction.
Tue, 13 Jun 2017 09:03:00 -0400 FDA requests removal of Opana ER for risks related to abuse Today, the U.S. Food and Drug Administration requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market. After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks. This is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse.
Thu, 08 Jun 2017 16:15:00 -0400 FDA expands use of Sapien 3 artificial heart valve for high-risk patients The U.S. Food and Drug Administration today approved an expanded indication for the Sapien 3 Transcatheter Heart Valve (THV) for patients with symptomatic heart disease due to failure of a previously placed bioprosthetic aortic or mitral valve whose risk of death or severe complications from repeat surgery is high or greater.
Mon, 05 Jun 2017 15:44:00 -0400 FDA approves first generic Strattera for the treatment of ADHD The U.S. Food and Drug Administration today approved the first generic versions of Strattera (atomoxetine) to treat attention-deficit/hyperactivity disorder (ADHD) in pediatric and adult patients.
Tue, 30 May 2017 16:49:00 -0400 FDA approves first cancer treatment for any solid tumor with a specific genetic feature The U.S. Food and Drug Administration today granted accelerated approval to a treatment for patients whose cancers have a specific genetic feature (biomarker). This is the first time the agency has approved a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated
Tue, 23 May 2017 15:01:00 -0400
Diabetes news from the American Diabetes Association
