Esophageal Cancer: HMIE Procedure Reduces Morbidity Without Sacrificing Efficacy

MedicalResearch.com Interview with:

Guillaume Piessen, MD, PhD University Hospital Centre Lille, France

Prof. Piessen

Guillaume Piessen, MD, PhD
University Hospital Centre
Lille, Franc

MedicalResearch.com: What is the background for this study?

Response: Patients requiring surgery for esophageal cancer fare better after undergoing a hybrid minimally invasive esophagectomy (HMIE) with a combined laparoscopy+thoracotomy procedure compared to an open esophagectomy (OE), according to results of the MIRO trial published in the last issue of the New England Journal Of Medicine (link article).

This French prospective multi-center randomized controlled study was funded by the French National Cancer Institute (Grant n° 1907). The study was conducted by Pr Mariette who sadely passed away in 2017 and Pr Piessen (Department of Digestive and Oncological Surgery, CHU Lille), under the hauspice of FRENCH (Fédération de Recherche EN Chirurgie) and FREGAT (French Eso-Gastric Tumors) working group (https://www.fregat-database.org/fr/).

Postoperative morbidity, especially pulmonary complications, affects more than half of patients after open esophagectomy for esophageal cancer.

Hybrid minimally invasive esophagectomy (HMIE) combines a laparoscopic abdominal phase with an open thoracotomy, which may have specific advantages including lower rate of pulmonary complications, without laparoscopic tumor dissection limiting potential tumor spillage and easier reproducibility of the technique [12].

Postoperative morbidity, especially pulmonary complications, affects more than half of patients after open esophagectomy for esophageal cancer.

Hybrid minimally invasive esophagectomy (HMIE) combines a laparoscopic abdominal phase with an open thoracotomy, which may have specific advantages including lower rate of pulmonary complications, without laparoscopic tumor dissection limiting potential tumor spillage and easier reproducibility of the technique [12].

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Parents: Vaping is Drawing Adolescents into Nicotine Use

MedicalResearch.com Interview with:

Richard Miech Ph.D Professor Principal Investigator, Monitoring the Future Institute for Social Research University of Michigan

Dr. Miech

Richard Miech Ph.D
Professor
Principal Investigator, Monitoring the Future
Institute for Social Research
University of Michigan

MedicalResearch.com: What is the background for this study? What are the main findings?

 Response: Every year Monitoring the Future conducts a survey to examine trends in adolescent substance use.  We draw a random sample of schools from a list of all schools in the United States and conduct our survey in ~400 schools.  Our survey is representative of U.S. 8th, 10th, and 12th grade students.  In other words, our results are what you would find if you surveyed every single 8th, 10th, and 12th graders in the United States, within the bounds of a small sampling error of a few percentage points.

An increase in vaping is the big news for 2018.  In 10th and 12th grade the increase in nicotine vaping was the largest we’ve ever seen for any substance in the past 43 years.  As a result of this increase in nicotine vaping, overall use of nicotine increased as well, which suggests that vaping is drawing youth into nicotine use.  We also saw a significant increase in marijuana vaping. Continue reading

Pancreatic Cancer: mFOLFIRINOX After Surgery Improves Survival

MedicalResearch.com Interview with:

Pr Thierry Conroy | Director

Prof. Conroy

Prof. Thierry Conroy MD, Director
Department of Medical Oncology
Institut de Cancérologie de Lorraine
Vandoeuvre-lès-Nancy CEDEX

MedicalResearch.com: What is the background for this study?

Response:  Surgery of pancreatic cancer offers the only chance of cure. Despite the low response rate (5% – 9%) of gemcitabine in metastatic disease, a 6-month regimen of adjuvant therapy with gemcitabine increases 5-year survival from 10% to 20% and is recognized as standard of care. However, recurrence rate remain high despite adjuvant treatment with 69-75% of patients relapsing within 2 years.

–       The combination of bolus and continuous infusion Fluorouracil, Folinic Acid, Irinotecan and Oxaliplatin (Folfirinox) was shown to increase response rate (31.6% versus 9.4%) in metastatic disease as compared to Gemcitabine and increase survival (11.1 versus 6.8 months).

–       Deletion of bolus Fluorouracil in the Folfirinox regimen (mFOLFIRINOX) decreased toxicity and do not reduce efficacy in advanced disease.

–       We performed a randomized trial in patients with good performance status, ECOG 0-1 CA 19.9 ≤ 180 U/L and no cardiac contraindication to fluorouracil.

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Reclast, Zometa (zoledronate) Reduced Fractures in Osteopenic Older Women

MedicalResearch.com Interview with:

Prof Ian Reid Faculty of Medical and Health Sciences University of Auckland Auckland New Zealand

Prof. Reid

Prof Ian Reid MD
Faculty of Medical and Health Sciences
University of Auckland
Auckland New Zealand


MedicalResearch.com: What is the background for this study? 

Response: Bisphosphonates prevent fractures in patients with osteoporosis, but their efficacy in women with osteopenia is unknown. Most fractures in postmenopausal women occur in osteopenic patients, so therapies with efficacy in osteopenia are needed.

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Probiotics Found Unhelpful in Kids With Outpatient Diarrhea

Stephen Freedman MDCM, MSc Alberta Children's Hospital Foundation Professor in Child Health and Wellness Sections of Pediatric Emergency Medicine and Gastroenterology Alberta Children's Hospital & Research Institute University of Calgary Calgary, AB

Dr. Freedman

MedicalResearch.com Interview with:
Stephen Freedman MDCM, MSc
Alberta Children’s Hospital Foundation Professor in Child Health and Wellness
Sections of Pediatric Emergency Medicine and Gastroenterology
Alberta Children’s Hospital & Research Institute
University of Calgary
Calgary, AB

 MedicalResearch.com: What is the background for this study?

Response: Vomiting and diarrhea remain extremely common diseases in children and are the most common reason children are brought for emergency department care in North America.  While we have options to reduce vomiting there historically has been little physicians can offer to reduce the severity of the diarrhea.

Probiotics have recently emerged as an option with some early evidence of benefit in clinical trials but the studies performed to date have been small and few little research has been conducted in North America in outpatient or emergency department children.

The one study to date that was performed in a US emergency department did not find probiotic use to be beneficial.  Given the increasing importance of clarifying this issue we undertook this study.

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New Drug Class Holds Promise Against Antibiotic Resistant Gonorrhea

MedicalResearch.com Interview with:

Intracellular Gram-negative, Neisseria gonorrhoeae diplococcal bacteria, - CDC image

Intracellular Gram-negative, Neisseria gonorrhoeae diplococcal bacteria, – CDC image

Edward W. Hook, III, MD
University of Alabama at Birmingham
Medicine / Infectious Diseases
Birmingham, AL

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Zoliflodacin represents a new class of antibiotics (spiropyrimidinetriones) with in vitro activity against Neisseria gonorrhoeae, as well as other STD  pathogens (Chlamydia trachomatis and Mycoplasma genitalium).  Because of this promising data and the fact that the manufacturer (Entasis Pharmaceuticals) was willing to pursue the possibility of using this drug to treat gonorrhea, a Phase II trial was conducted which showed he drug to be 96% effective for genital or rectal infections.  The drug was well tolerated as well making it a promising drug for gonorrhea treatment which might help to combat the increasing problem of antibiotic resistant gonorrhea.  Continue reading

Critical Illness: Haloperidol and Ziprasidone for Treatment of Delirium

MedicalResearch.com Interview with:

Brenda Truman Pun, DNP, RN Program Clinical Manager Vanderbilt University Medical Center

Dr. Truman Pun

Brenda Truman Pun, DNP, RN
Program Clinical Manager
Vanderbilt University Medical Center

MedicalResearch.com: What is the background for this study?

Response: Delirium is a serious problem in Intensive Care Units around the world. Approximately 80% of mechanically ventilated patients develop delirium, acute confusion, while in the ICU. Once thought to be a benign side effect of the ICU environment, research now shows that delirium is linked to a myriad of negative outcomes for patients which include longer ICU and Hospital stays, prolonged time on the ventilator, increased cost, long-term cognitive impairment and even mortality. For a half a century clinicians have been using haloperidol, an typical antipsychotic, to treat delirium in the ICU. However, there has never been evidence to support the use of haloperidol or its pharmacologic cousins, the atypical antipsychotics, to treat delirium. These drugs have serious side effects that include heart arrhythmias, muscle spasms, restlessness and are associated with increased mortality when given for prolonged periods in the outpatient settings leading to a black box warning for their use in this setting.

The MIND-USA study was a double blind placebo controlled trial which evaluated the efficacy and safety of antipsychotics (i.e., haloperidol and ziprasidone) in the treatment delirium in adult ICU patients.   Continue reading

Genetic Variant is Risk Factor for Two Different Types of Interstitial Lung Disease

MedicalResearch.com Interview with:

Joyce S. Lee, MD Associate Professor Director, Interstitial Lung Disease Program Department of Medicine Division of Pulmonary Sciences and Critical Care Medicine University of Colorado School of Medicine

Dr. Lee

Joyce S. Lee, MD
Associate Professor
Director, Interstitial Lung Disease Program
Department of Medicine
Division of Pulmonary Sciences and Critical Care Medicine
University of Colorado School of Medicine

MedicalResearch.com: What is the background for this study? What are the main findings? 

Response: Rheumatoid arthritis (RA) is a common inflammatory arthritis that can be complicated by interstitial lung disease (ILD). Patients with RA-ILD share clinical characteristics with another ILD called idiopathic pulmonary fibrosis (IPF).

Given the similar clinical phenotype, our goal was to see if these lung diseases (IPF and RA-ILD) shared a common genetic risk factor. The MUC5B promoter variant is the most common risk factor (genetic and otherwise) for the development of IPF.

Our findings demonstrate the MUC5B promoter variant is also a strong risk factor for the development of RA-ILD among patients with RA.

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Do Antipsychotics Shorten Duration of Delirium in ICU Patients?

MedicalResearch.com Interview with:

Eugene Wesley Ely, M.D. Dr. E. Wesley Ely is a Professor of medicine at Vanderbilt University School of Medicine with subspecialty training in Pulmonary and Critical Care Medicine.

Dr. Ely
Photo: Anne Rayner, VU

Eugene Wesley Ely, M.D.
Dr. E. Wesley Ely is a Professor of medicine at Vanderbilt University School of Medicine with subspecialty training in Pulmonary and Critical Care Medicine. 

MedicalResearch.com: What is the background for this study?

Response: Critically ill patients are not benefitting from antipsychotic medications that have been used to treat delirium in intensive care units (ICUs) for more than four decades, according to a study released today in the New England Journal of Medicine.

Each year, more than 7 million hospitalized patients in the United States experience delirium, making them disoriented, withdrawn, drowsy or difficult to wake.

The large, multi-site MIND USA (Modifying the INcidence of Delirium) study sought to answer whether typical and atypical antipsychotics — haloperidol or ziprasidone —affected delirium, survival, length of stay or safety.

Researchers screened nearly 21,000 patients at 16 U.S. medical centers. Of the 1,183 patients on mechanical ventilation or in shock, 566 became delirious and were randomized into groups receiving either intravenous haloperidol, ziprasidone or placebo (saline).

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Brain Change in Addiction as Learning, Not Disease

MedicalResearch.com Interview with:

Marc Lewis, Ph.D. Klingelbeekseweg Arnhem The Netherlands

Prof. Lewis

Marc Lewis, Ph.D.
Klingelbeekseweg Arnhem
The Netherlands

MedicalResearch.com: What is the background for this study?

Response: According to the brain disease model, addiction is a chronic disease brought about by changes in brain systems that mediate the experience and anticipation of reward and higher-order systems underlying judgment and cognitive control. Its proponents propose that these changes are driven by exposure to drugs of abuse or alcohol. The brain disease model is the most prevalent model of addiction in the Western world.

The disease model’s narrow focus on the neurobiological substrates of addiction has diverted attention (and funding) from alternative models. Alternatives to the brain disease model highlight the social-environmental factors that contribute to addiction and the learning processes that translate these factors into negative outcomes. Learning models propose that addiction, though obviously disadvantageous, is a natural, context-sensitive response to challenging environmental contingencies, not a disease.

In this review I examine addiction within a learning framework that incorporates the brain changes seen in addiction without reference to pathology or disease.  Continue reading

Most Overweight or Obese Children Will Stay So

MedicalResearch.com Interview with:

Antje Körner, M.D Center for Pediatric Research University Hospital for Children and Adolescents University of Leipzig Germany

Dr. Körner

Antje Körner, M.D
Center for Pediatric Research
University Hospital for Children and Adolescents
University of Leipzig
Germany

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: We were interested to find out, when (at what age) obesity in children emerges, whether there is something such as an critical age.

There are many opinions on that but very few well-powered studies. We tracked weight/BMI development of more than 51,000 children from infancy to adolescence. We see, that it is clearly early childhood – the preschool years when obesity sets in in the children. If a child is obese at one or up to two years of age, chances are about 50:50 to return to normal weight; with 3 years of age, most children with overweight or obesity will stay so, almost 90%.

When we look at it dynamically, we see the strongest increase in excessive weight between 2 and 6 years of age in those adolescents who are obese. Even after that young age there is steady further increase in additional weight gain, hence worsening of obesity. 

MedicalResearch.com: What should readers take away from your report?

Response: Our intention is to raise awareness that obesity sets in at that very young age. Often you hear of “innocent puppy fat” in the very young children, which will grow away. According to our data you cannot rely on returning to normal weight as soon as 3 years of age.

MedicalResearch.com: What recommendations do you have for future research as a result of this work?

Response: Therefore, we have to think more in means of prevention. This early childhood is the age where habits are formed. Hence every day life should be structured in a healthy way and environment should favour a healthy life style. 

Citation:

Acceleration of BMI in Early Childhood and Risk of Sustained Obesity

Mandy Geserick, M.Sc., Mandy Vogel, Ph.D., Ruth Gausche, M.B.A., Tobias Lipek, M.D., Ulrike Spielau, M.Sc., Eberhard Keller, M.D., Roland Pfäffle, M.D., Wieland Kiess, M.D., and Antje Körner, M.D.

October 4, 2018
N Engl J Med 2018; 379:1303-1312
DOI: 10.1056/NEJMoa180352

Oct 5, 2018 @ 12:41 pm

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Zoledronate (Reclast, Zometa) Reduced Fractures in Older Women with Osteopenia

MedicalResearch.com Interview with:

Prof Ian Reid Faculty of Medical and Health Sciences University of Auckland Auckland New Zealand 

Prof. Reid

Prof Ian Reid
Faculty of Medical and Health Sciences
University of Auckland
Auckland New Zealand 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Bisphosphonates prevent fractures in patients with osteoporosis, but their efficacy in women with less marked bone loss (referred to as osteopenia) is unknown.

Most fractures in postmenopausal women occur in osteopenic patients, so therapies with efficacy in osteopenia are needed.

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NEJM: Rivaroxaban (XARELTO®) For Thromboembolism Prevention after Medical Illness

MedicalResearch.com Interview with:

Alex C Spyropoulos, MD, FACP, FCCP, FRCPC Professor of Medicine – The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell Professor - The Center for Health Innovations and Outcomes Research - The Feinstein Institute for Medical Research System Director – Anticoagulation and Clinical Thrombosis Services Northwell Health at Lenox Hill Hospital New York, NY 10075

Dr. Spyropoulos

Alex C Spyropoulos, MD, FACP, FCCP, FRCPC
Professor of Medicine – The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell
Professor – The Center for Health Innovations and Outcomes Research – The Feinstein Institute for Medical Research
System Director – Anticoagulation and Clinical Thrombosis Services
Northwell Health at Lenox Hill Hospital
New York, NY 10075

MedicalResearch.com: What is the background for this study?

Response: Hospitalised medically ill patients have a significant risk of developing venous thromboembolism (VTE) within 6 weeks after discharge. The role of extended thromboprophylaxis in this population with either low molecular weight heparin or the direct oral anticoagulants remains uncertain, as it has shown either excess bleeding or beneficial effects mainly from reducing asymptomatic deep vein thrombosis (DVT).

The MARINER trial was designed to compare rivaroxaban with placebo for the prevention of the composite outcome of symptomatic VTE and VTE-related death in medically ill patients at increased risk of VTE post-hospital discharge. The principal safety objective was major bleeding.

The trial was a randomized, double-blind, placebo-controlled, event-driven study that included a total of 12,024 patients aged ≥40 years who had been hospitalised with an acute medical illness for 3-10 consecutive days and had additional VTE risk factors as defined by the modified IMPROVE VTE risk score of ≥4 or a score of 2 or 3 plus a plasma D-dimer level more than twice the upper limit of normal). The rivaroxaban regimen consisted of 10 mg once daily in patients with a creatinine clearance (CrCl) of >=50ml/min or 7.5 mg for patients with a CrCl of 30 to <50 ml/min. The first dose was given on the day of discharge and the last dose at Day 45. Patients were followed up for an additional 30 days. Baseline characteristics were well matched between groups and typical of a medically ill population.

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Outbreak of Synthetic Cannabinoid–Associated Bleeding Disorders in Illinois

MedicalResearch.com Interview with:

Dr. Amar Kelkar MD Clinical Fellow Division of Hematology & Oncology, Department of Medicine University of Florida College of Medicine, UF Health Shands Hospital

Dr. Kelkar

Dr. Amar Kelkar MD
Clinical Fellow
Division of Hematology & Oncology, Department of Medicine
University of Florida College of Medicine, UF Health Shands Hospital

MedicalResearch.com: What is the background for this study? What are synthetic cannabinoids?

Response: Starting in March 2018, patients began reporting to hospitals and clinics with unexplained and prolonged bleeding symptoms, first in Chicago, Illinois, and then spreading to Peoria, Illinois and elsewhere. This gained a lot of press because the initial identifying factor was that all the patients had reported recent use of synthetic cannabinoids. As the matter was studied further, it was determined that these patients were likely exposed to an anticoagulant poison mixed in with the synthetic cannabinoids.

Synthetic cannabinoids are lab-derived illicit drugs that target the cannabinoid receptors that are also targeted by marijuana. They go by many names including synthetic marijuana, K2, and Spice.

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What Happens When Pay for Performance Incentives Are Withdrawn?

MedicalResearch.com Interview with:

Prof-Bruce Guthrie Head of Population Health Sciences Division Professor of Primary Care Medicine and Honorary Consultant NHS Fife

Prof. Guthrie

Prof. Bruce Guthrie PhD
Head of Population Health Sciences Division
Professor of Primary Care Medicine and Honorary Consultant NHS Fife 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The UK Quality and Outcomes Framework (QOF)) is a primary care pay for performance programme (P4P) implemented in 2004. QOF was and still is the largest healthcare P4P programme in the world, initially having ~150 indicators and accounting for ~20% of practice income. QOF has been reduced in scale and scope over time, with 40 indicators retired in 2014. It was abolished in Scotland in 2016 and is due to be further reformed in England. There is some evidence that P4P (and QOF itself) is associated with modest improvements in quality when introduced, but little evidence about what happens when financial incentives are withdrawn.

Our study examined what happened when incentives were withdrawn in 2014 for 12 indicators where there is good before and after data. There were immediate reductions in documented quality of care, which were similar in size to improvements observed when incentives were introduced. These reductions were small to modest (~10%) for indicators relating to care that is already systematically delivered (eg routine diabetes, hypertension and cardiovascular disease) and large for indicators which has historically been less systematically delivered (eg lifestyle advice).

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Subcutaneous Emicizumab Reduces Number of Injections Needed to Control Hemophilia

MedicalResearch.com Interview with:

Dr. Johnny Mahlangu  MBBCh Faculty of Health Sciences University of the Witwatersrand and National Health Laboratory Service Johannesburg, South Africa

Dr. Mahlangu

Dr. Johnny Mahlangu  MBBCh
Faculty of Health Sciences
University of the Witwatersrand and National Health Laboratory Service
Johannesburg, South Africa

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Current unmet needs in patients with haemophilia without inhibitors are the high disease burden imposed by the frequent injections which have to be given intravensously .

Emicizumab which is given subcutaneously weekly or fortnightly aims to address these unmet needs.

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Ibudilast Slowed Brain Atrophy Progressive Multiple Sclerosis in Phase 2 Study

MedicalResearch.com Interview with:

Robert J. Fox, MD, FAAN Principal Investigator | SPRINT-MS Trial Mellen Center for MS  |  Cleveland Clinic Cleveland, OH 44195  

Dr. Fox

Robert J. Fox, MD, FAAN
Principal Investigator | SPRINT-MS Trial
Mellen Center for MS  |  Cleveland Clinic
Cleveland, OH 44195 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The current treatment options for progressive multiple sclerosis are very limited. The SPRINT-MS trial sought to obtain proof-of-concept evidence that ibudilast has beneficial activity in progressive multiple sclerosis. In a placebo-controlled, 96-week trial of 255 people living with progressive MS, treatment with ibudilast slowed the progression of brain atrophy (brain shrinkage) by 48% compared to placebo. Side-effects of ibudilast included gastrointestinal symptoms, headache, and depression. 

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Percutaneous Repair or Medical Treatment for Secondary Mitral Regurgitation?

MedicalResearch.com Interview with:
Jean François Obadia Adult Cardiovascular Surgery and Transplantation Louis Pradel HospitalJean François Obadia MD PhD
Adult Cardiovascular Surgery and Transplantation
Louis Pradel Hospital

MedicalResearch.com: What is the background for this study?

-By definition a secondary MR concerns a normal valve or sub normal valve inside a dilated heart with poor LV function in a population of Heart failure patients. It is perfectly established today that secondary MR is a predictor of poor clinical outcomes of thissevere population.

-Therefore,it has been proposed to treat those regurgitation either by surgery (mainly the downsizing anuloplasty) or by percutaneous technique like the mitraclipwhich has been used more and more frequently recently.

-However, a beneficial effect on hardclinical outcomes has never been provedandwe still don’t know if those regurgitations need to be corrected or not, We still don’t Know if the regurgitation is the cause, the consequence or just a marker of poor prognosis.

-In this context according to the guidelines, there is a low level of evidence to support those treatments, and Europe and US Guidelines call for prospective randomized studies in this severe population.​

And this excatly what we have done with MITRA-FR

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Coronary CT Angiography May Be Best Approach to Chest Pain

MedicalResearch.com Interview with:

Prof David Newby FRSE FMedSci Personal Chair - BHF John Wheatley Chair of Cardiology University of Edinburgh

Prof. Newby

Prof David Newby FRSE FMedSci
Personal Chair – BHF John Wheatley Chair of Cardiology
University of Edinburgh

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: There are many tests that can try and determine whether a patient has heart disease. All are imperfect and do not directly see if the heart arteries are diseased.

This study used a CT heart scan to see if there was any heart disease in patients who presented to the outpatient clinic with chest pains that could be due to coronary heart disease. The doctor use the scan result to decide whether they had heart disease and how to manage the patient.

The study has found that if you use a CT heart scan then you are less likely to have a heart attack in the future. In the first year, you may require treatment with an angiogram and heart surgery (stent or heart bypass) but after the first year, you are less likely to need these treatments because the disease has already been treated promptly.

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Single Dose of Ibalizumab Boosts Immunity in Resistant HIV

MedicalResearch.com Interview with:

Brinda Emu, MD Assistant Professor of Medicine (Infectious Diseases) Yale School of Medicine

Dr. Emu

Brinda Emu, MD
Assistant Professor of Medicine (Infectious Diseases)
Yale School of Medicine

MedicalResearch.com: What is the background for this study?

Response: This was a Phase 3 study of a new antiretroviral agent, ibalizumab, for the treatment of HIV-1 infection.  Ibalizumab is a monoclonal antibody that targets the CD4 receptor on host cells.  CD4 is the receptor that HIV uses to infect CD4+ T cells.  By binding to the CD4 receptor, ibalizumab prevents viral entry.  This study recruited patients that harbor multi-drug resistant HIV and were failing their current regimen of antiretroviral agents, and thus had limited options for treatment of their HIV-1 infection using approved medications.

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Elective Induction at 39 Weeks May Reduce Need for Cesarean Section

MedicalResearch.com Interview with:

George R. Saade, MD Professor Jennie Sealy Smith Distinguished Chair Professor, Obstetrics & Gynecology, and Cell Biology Chief of Obstetrics and Maternal Fetal Medicine Director, Perinatal Research Division Department of Obstetrics and Gynecology Division of Maternal Fetal Medicine UTMB at Galveston

Dr. Saade

George R. Saade, MD
Professor Jennie Sealy Smith Distinguished Chair Professor,
Obstetrics & Gynecology, and Cell Biology
Chief of Obstetrics and Maternal Fetal Medicine
Director, Perinatal Research Division
Department of Obstetrics and Gynecology Division of Maternal Fetal Medicine
UTMB at Galveston

MedicalResearch.com: What is the background for this study?

Response: Several analyses show that the lowest risk to the baby is if delivered at 39 weeks. As pregnancy goes beyond 39 weeks, the risk to the baby increases. On the other hand, the general belief was that induction of labor at 39 increases the risk of cesarean and may not be good for the baby. The guideline were that induction without medical indication, or what we call elective induction of labor, should not be done. However, the studies on which this belief was based were not appropriately designed or analyzed. These studies compared women who were induced at 39 weeks to those who had spontaneous labor at 39 weeks. This comparison is not appropriate. While induction is a choice, having spontaneous labor at 39 weeks is not by choice.  So the correct comparison should be between women who were induced at 39 weeks to those who were not induced and continued their pregnancy beyond 39 weeks. In other words, they continued until they had spontaneous labor or developed an indication to be delivered (expectantly managed). That is how the study was done. First time pregnant women were randomized between these 2 options. The reason the study was done in first time mothers is that they have the highest risk of cesarean compared with women who had delivered vaginally before.

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Harmless or Hormone disorder?  New Test Enables Quick Diagnosis For Drinking by the Liter

MedicalResearch.com Interview with:

Prof. Dr. Mirjam Christ-Crain Professor of endocrinology, diabetes and metabolism Heads the Department of Clinical Research University and University Hospital of Basel 

Prof. Christ-Crain

Prof. Dr. Mirjam Christ-Crain
Professor of endocrinology, diabetes and metabolism
Heads the Department of Clinical Research
University and University Hospital of Basel  

MedicalResearch.com: What is the background for this study? Would you briefly explain what is meant by Diabetes Insipidus?

Response: Drinking more than three litres per day with the equivalent increase in urination is regarded as too much. This drinking by the liter – known as “polyuria polydipsia syndrome” – usually develops over time through habit, or can be a side effect of a mental illness.

In rare cases, however, it may be caused by diabetes insipidus. This is when the pituitary gland lacks the hormone vasopressin, which regulates the water and salt content in our body. Patients have a decreased ability to concentrate the urine, therefore lose a lot of fluid and have to increase their fluid intake accordingly to prevent dehydration (= Diabetes insipidus).

The distinction between what is considered a “harmless” primary polydipsia and a diabetes insipidus is crucial, as their therapy is fundamentally different. Diabetes insipidus must be treated with the hormone vasopressin, while patients with primary polydipsia require behavioural therapy to reduce their habitual drinking. A wrong therapy can have life-threatening consequences as treatment with vasopressin without indication can lead to water intoxication.

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Biomarker Procalcitonin Offered Limited Benefit Over Clinical Judgement In Antibiotic Prescribing Patterns

MedicalResearch.com Interview with:

David T. Huang, MD, MPH Associate Professor, Critical Care Medicine, Emergency Medicine, Clinical and Translational Science Director, MACRO (Multidisciplinary Acute Care Research Organization) Director, CRISMA Administrative Core (Clinical Research, Investigation, and Systems Modeling of Acute illness) University of Pittsburgh

Dr. David Huang

David T. Huang, MD, MPH
Associate Professor, Critical Care Medicine, Emergency Medicine, Clinical and Translational Science
Director, MACRO (Multidisciplinary Acute Care Research Organization)
Director, CRISMA Administrative Core (Clinical Research, Investigation, and Systems Modeling of Acute illness)
University of Pittsburgh

MedicalResearch.com: What is the background for this study?

Response: The overuse of antibiotics has become a serious threat to global public health, causing antibiotic resistance and increasing health care costs. Physicians have long known that antibiotics are usually unnecessary for acute bronchitis and for some other cases of lower respiratory tract infections, and that antibiotics treat only bacterial infections, not viral. But in daily practice, many physicians often prescribe them.

Previous research had reported that using a biomarker blood test and following an antibiotic guideline tied to the test results could reduce antibiotic use in lower respiratory tract infections. In February 2017, the U.S. Food and Drug Administration approved the biomarker test that measures procalcitonin – a peptide that typically increases in bacterial infections, but not viral.

We conducted the Procalcitonin Antibiotic Consensus Trial (ProACT) trial to evaluate whether a procalcitonin antibiotic prescribing guideline, implemented for the treatment of suspected lower respiratory tract infection with reproducible strategies, would result in less exposure to antibiotics than usual care, without a significantly higher rate of adverse events.

The ProACT trial involved 14 predominately urban academic hospitals. We enrolled 1,656 adult patients who presented to the hospital emergency department and were initially diagnosed with a lower respiratory tract infection. All the patients were tested for their procalcitonin levels, but the results were shared only with the physicians of the patients randomly assigned to procalcitonin-guided antibiotic prescription.

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TPOXXÒ (tecovirimat): Novel Antiviral Agent in the Event of a Smallpox Epidemic

MedicalResearch.com Interview with:

This 1967 photograph, which was captured in Accra, Ghana, depicts the face of a smallpox patient CDC/ John Noble, Jr., M.D.

This 1967 photograph, which was captured in Accra, Ghana, depicts the face of a smallpox patient.

Dr. Dennis E. Hruby PhD
Chief Science Officer of SIGA Technologies
Corvallis, OR

MedicalResearch.com: What is the background for this study? 

Response: Naturally occurring smallpox was declared eradicated in 1980 following coordinated decades-long global vaccination campaigns. However, there is a significant concern that smallpox, which is both highly contagious and highly lethal, could be used as a potential bioweapon.

DNA synthesis technology and the possibility of unaccounted for smallpox stocks pose significant risks. While there are two publicly acknowledged stocks of smallpox virus held by the United States and Russia, some believe that additional stores of the virus could be in the hands of governments or organizations that might use them to cause harm. The DNA sequence of the smallpox genome is in the public domain and could potentially be synthesized in a laboratory from scratch or created by genetically modifying a similar virus.

Currently, there are no therapies approved for the treatment of smallpox infection. A smallpox bioterror attack could be especially damaging because the majority of today’s population is not immune to the virus, as routine vaccination ended in the 1970s. It is estimated that without vaccination or treatment, each person infected with smallpox would infect 5 – 7 others. Rapid spread from person-to-person can occur through speaking, breathing or touching. Smallpox also can be transmitted by direct contact with infected fluids and contaminated objects. Furthermore, vaccination must occur within 3-5 days of exposure to smallpox, when patients are still asymptomatic, to be effective. These limitations underscore the need for an effective smallpox antiviral therapy, in addition to any available vaccine.

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Enzalutamide (Xtandi) Provides Men with NonMetastatic Castration Resistant Prostate Cancer an Effective Treatment Option

MedicalResearch.com Interview with:

Maha Hussain, MD, FACP, FASCO Genevieve Teuton Professor of Medicine Division of Hematology/Oncology Deputy Director Robert H. Lurie Comprehensive Cancer Center Northwestern University Feinberg School of Medicine

Dr. Hussain

Maha Hussain, MD, FACP, FASCO
Genevieve Teuton Professor of Medicine
Division of Hematology/Oncology
Deputy Director
Robert H. Lurie Comprehensive Cancer Center
Northwestern University Feinberg School of Medicine

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Until recently patients with non metastatic castration resistant prostate cancer (nmcrpc) had no impactful systemic therapy options.  Progression to metastatic crpc; the deadly phase of the cancer, is a given in the vast majority of patients.

Enzalutamide significantly delayed the time to metastases development by almost 2 years compared to placebo with a 71% reduction in the risk of metastases or death and a median metastases free survival of 36.6 compared to 14.7 months respectively.  This was accomplished without negative impact on quality of life (qol).  Enzalutamide treated patients had a higher rate of PSA declines and delayed time to requiring other anticancer therapies.   

MedicalResearch.com: What should readers take away from your report?

Response: Androgen receptor targeting continues to be clinically relevant in this disease and the therapeutic impact is greater in earlier disease settings with lower tumor burden. This data provides men with non metastatic castration resistant prostate cancer an effective treatment option.

MedicalResearch.com: What recommendations do you have for future research as a result of this work? 

Response: In this disease setting maximizing the antitumor effect with rational combinations to increase tumor kill with the goal of further reducing the risk of metastasis and prolonging overall survival and potentially hope for “cure”. 

MedicalResearch.com: Is there anything else you would like to add? Any disclosures:

Response: On behalf of all my coauthors and study investigators I wish to thank the patients and their caregivers for participating in this trial.  Their partnership is critical to defeat prostate cancer.

Research funding to our institutions for clinical trials from Pfizer.

Citation:

Enzalutamide in Men with Nonmetastatic, Castration-Resistant Prostate Cancer

Maha Hussain, M.D., Karim Fizazi, M.D., Ph.D., Fred Saad, M.D., Per Rathenborg, M.D., Neal Shore, M.D., Ubirajara Ferreira, M.D., Ph.D., Petro Ivashchenko, M.D., Eren Demirhan, Ph.D., Katharina Modelska, M.D., Ph.D., De Phung, B.S., Andrew Krivoshik, M.D., Ph.D., and Cora N. Sternberg, M.D.
June 28, 2018
N Engl J Med 2018; 378:2465-2474
DOI: 10.1056/NEJMoa1800536

 

 

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