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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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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Vaccines Against Rotavirus Gastroenteritis Decreased Infections Even in Unvaccinated Kids

MedicalResearch.com Interview with:

Chuanxi Fu, MD.PhD. Professor of Epidemiology, School of Public Health Zhejiang Chinese Medical University Associate editor, Human Vaccines & Immunotherapeutics

Dr. Chuanxi Fu

Chuanxi Fu, MD.PhD.
Professor of Epidemiology, School of Public Health
Zhejiang Chinese Medical University
Associate editor, Human Vaccines & Immunotherapeutics 

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

Response: Since 2000, the Lanzhou lamb rotavirus vaccine has been exclusively licensed in China for voluntary rotavirus gastroenteritis prevention, however, the effects of the vaccination on population health, including any indirect impact to unvaccinated individuals have not been evaluated.

In the study enrolled 33 407 patients with rotavirus gastroenteritis from 2007 to 2015 seasons in southern China shows vaccination effects in which the median age at onset increased by 4 months, and onset, peak, and cessation of incidence were delayed. The incidence rate ratio among children younger than 4 years and among children ineligible for vaccination decreased as citywide vaccination coverage increased, and the adjusted odds ratio for rotavirus gastroenteritis among unvaccinated infants decreased in areas with higher vaccination coverage.  Continue reading

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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For Resistant HIV: Phase III Trial of Trogarzo Demonstrates Safety and Efficacy

MedicalResearch.com Interview with:
TaiMed BiologicsStanley Lewis, M.D.

TaiMed Biologics
Irvine, CA 92614


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

Response: The phase III clinical trial was conducted to assess the efficacy and safety of Trogarzo™ (ibalizumab-uiyk) injection in patients with multidrug resistant HIV-1. The study design was approved by the FDA. Results obtained were included in the New Drug Application submitted to the FDA which approved Trogarzo™ on March 6, 2018.

The phase III, open-label study, enrolled 40 patients with multidrug-resistant (MDR) HIV-1 in whom multiple antiretroviral therapies had failed. All patients at baseline were experiencing viral failure. After a seven-day control period, patients received an intravenous 2000 mg loading dose of Trogarzo™ which was the only change made to their antiretroviral regimen. Through the 24-week treatment period of the study, patients were given a maintenance dose of 800 mg of Trogarzo™ every two weeks along with an optimized background regimen that included at least one additional fully active agent.

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Should Hormonal Therapy Be Extended Past Five Years After Estrogen+ Breast Cancer?

MedicalResearch.com Interview with:

Dr Hongchao Pan PhD Medical Research Council Population Health Research Unit Clinical Trial Service Unit & Epidemiological Studies Unit Nuffield Department of Population Health Oxford 

Dr Hongchao Pan

Dr Hongchao Pan PhD
Medical Research Council Population Health Research Unit
Clinical Trial Service Unit & Epidemiological Studies Unit
Nuffield Department of Population Health
Oxford

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

Response: We’ve known for a long time that recurrences can occur late in women with oestrogen receptor positive breast cancers. Our study aimed to assess how big the risk was for women who had taken endocrine treatment (tamoxifen or an aromatase inhibitor) for 5 years, which greatly reduces the risk of recurrence (by about a half during treatment and one third for the 5 years after stopping). We also wanted to find out what factors influenced the risk of recurrence, and whether some women had such a low risk that they could safely stop hormonal treatment after 5 years or, conversely, whether other women had a particularly high risk so it would make sense for them to keep on taking hormonal treatment.

What we found by following the progress of over 60,000 women who had stopped hormonal treatment at 5 years is that the risk of the cancer spreading stays about the same for the next 15 years. This risk is much higher for women whose breast cancer had spread to the nodes when first diagnosed but even for those with the best outlook (no spread to the lymph nodes and small tumours), there was a 10% chance of cancer spread over 15 years.

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Localized Prostate Cancer: Patient-Reported Outcomes after Monitoring, Surgery, or Radiotherapy

MedicalResearch.com Interview with:

Professor Jenny Donovan  PhD   OBE FMedSci NIHR-SI AcSS FFPHM Director, NIHR CLAHRC West (National Institute for Health Research Collaboration for  Leadership in Applied Health Research and Care West) at University Hospitals Bristol NHS Trust Bristol, UK

Prof. Jenny Donovan

Professor Jenny Donovan  PhD
OBE FMedSci NIHR-SI AcSS FFPHM
Director, NIHR CLAHRC West
(National Institute for Health Research Collaboration for
Leadership in Applied Health Research and Care West)
at University Hospitals Bristol NHS Trust
Bristol, UK

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

Response: PSA testing identifies many men with prostate cancer, but they do not all benefit from treatment. Surgery, radiation therapy and various programs of active monitoring/surveillance can be given as treatments for fit men with clinically localized prostate cancer. Previous studies have not compared the most commonly used treatments in terms of mortality, disease progression and patient-reported outcomes. In the ProtecT study, we used a comprehensive set of validated measures, completed by the men at baseline (before diagnosis), at six and 12 months and then annually for six years.

The main finding is that each treatment has a particular pattern of side-effects and recovery which needs to be balanced against the findings from the paper reporting the clinical outcomes (Hamdy et al).

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Cord Blood Transplant in Leukemia With Minimal Residual Disease

MedicalResearch.com Interview with:

Dr. Filippo Milano, MD, PhD Assistant Member, Clinical Research Division Associate Director Cord Blood Transplantation Cord Blood Program Assistant Professor, University of Washington Fred Hutchinson Cancer Research Center

Dr. Filippo Milano

Dr. Filippo Milano, MD, PhD
Assistant Member, Clinical Research Division
Associate Director Cord Blood Transplantation
Cord Blood Program
Assistant Professor, University of Washington
Fred Hutchinson Cancer Research Center

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

Response: When first introduced, cord blood (CB) graft was used only as a last resort when no suitable conventional donor could be identified, largely due to the limiting cell doses available in a cord blood graft. A CB graft, however, is attractive due to the increased level of HLA disparity that can be tolerated, without increased risk of graft versus host disease, allowing nearly all patients to find such a donor.

The main intent of the study was to evaluate whether or not, at our Institution, cord blood SHOULD STILL BE considered only AS an alternative DONOR or IF instead outcomes were comparable to those obtained with more “conventional” types of transplants from matched and mismatched unrelated donors.

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Improved Survival with Combination Therapy for HER2- Positive Metastatic Breast Cancer

 

Swain_SandraMedicalResearch.com Interview with:
Sandra M Swain, MD, FACP, FASCO
Medical Director, Washington Cancer Institute
MedStar Washington Hospital Center
Washington DC 20010

MedicalResearch: What take-home message would you like the general public to understand about this new analysis from the Cleopatra study?

Potential Key Message Options:

  • Updated results from the CLEOPATRA study showed that people treated with the combination of pertuzumab, trastuzumb and chemotherapy lived 15.7 months longer than those who received trastuzumab and chemotherapy alone (median survival of 56.5 months versus 40.8 months).
  • The survival improvement of nearly 16 months observed in CLEOPATRA is unprecedented among studies of metastatic breast cancer. This is the kind of survival improvement that those of us who treat breast cancer strive for, and this data will be incredibly meaningful to patients and their families.
  • Furthermore, the median survival of nearly five years observed in CLEOPATRA patients treated with the pertuzumab regimen is the longest ever observed in a clinical study of people with HER2-positive metastatic breast cancer, once one of the most aggressive forms of breast cancer.
  • Patients who responded with shrinkage of their tumor had a response that was 8 months longer with the pertuzumab regimen compared to the trastuzumab and chemotherapy regimen.

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