First Report Of A Therapeutic Vaccine For Gluten Sensitive Celiac Disease

MedicalResearch.com Interview with:
Leslie Williams, BS, RN, MBA</strong> Director, Founder, President and Chief Executive Officer <strong>Dr Robert P Anderson MBChB BMedSc PhD FRACP</strong> Chief Scientific Officer ImmusanT Cambridge, MALeslie Williams, BS, RN, MBA

Director, Founder, President and
Chief Executive Officer and

Dr Robert P Anderson MBChB BMedSc PhD FRACP
Chief Scientific Officer
ImmusanT, Cambridge, MA

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

Response: The 2 Phase 1 trials were randomized, double-blind, placebo-controlled, multi-center studies evaluating the safety, tolerability, and relevant bioactivity of Nexvax2 in HLA-DQ2.5+ patients with celiac disease. In one study, patients received three fixed doses of Nexvax2 or placebo once per week over a three-week period. In the other study, patients received 16 fixed doses of Nexvax2 or placebo twice per week over an eight-week period. Both studies evaluated a range of fixed, intradermal dose administrations in a series of ascending dose cohorts, which included a crossover, double-blind, placebo-controlled oral gluten challenge in the screening and post-treatment periods. The primary outcome measures were the number and percentage of adverse events in the treatment period.

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Xpert HCV Viral Load Test Can Detect Active Hepatitis C Infection From Fingerstick

MedicalResearch.com Interview with:

Jason Grebely PhD Associate Professor Senior Research Fellow (UNSW) Viral Hepatitis Clinical Research Program

Dr. Grebely

Jason Grebely PhD
Associate Professor
Senior Research Fellow (UNSW)
Viral Hepatitis Clinical Research Program

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

Response: Globally, testing and diagnosis of hepatitis C virus infection remain low. Although point of care tests for HCV infection exist, but many of these tests only measure HCV antibodies (previous exposure), not HCV RNA (active infection). Given that 25% of individuals spontaneously clear HCV infection, efforts to enhance diagnosis of chronic HCV infection and improve the HCV care cascade requires enhanced uptake of HCV RNA testing.

We conducted the first evaluation of the Xpert HCV Viral Load test (manufactured by Cepheid) – a point-of-care hepatitis C virus test that can detect active infection – from a finger-stick sample of blood. We established that there is good sensitivity and specificity of the Xpert HCV Viral Load point-of-care test using blood samples collected by finger-stick in participants attending drug health and homelessness services in Australia.

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Emergency Transfusion of Patients with Unknown Blood Type with Blood Group O Rhesus D Positive Blood

MedicalResearch.com Interview with:
Dr. med. Kathleen Selleng, OÄ, QB Hämotherapie

Universitätsmedizin Greifswald
Institut für Immunologie und Transfusionsmedizin,
Abt. Transfusionsmedizin
Sauerbruchstraße
Greifswald Deutschland

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

Response: Red blood cell concentrates (RBCs) of blood group O RhD negative are frequently used as universal blood for emergency transfusions in patients with unknown blood type. This leads to an over-proportional use of these red blood cell concentrates and regular shortages of O RhD negative RBCs.

Due to these shortages, patients with known RhD negative blood type sometimes have to be transfused with RhD positive RBCs.

The present study shows that the overall risk to induce an anti-D by transfusing all emergency patients with unknown blood type with O RhD positive RBCs is in the range of 3 to 6%, while this risk is much higher (20-30%) in RhD negative patients which have to be transfused with RhD positive RBCs due to RhD negative RBC shortages.

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Intensive Therapy Facilitates Language Recovery in Chronic Aphasia After Stroke

MedicalResearch.com Interview with:
Caterina Breitenstein, PhD
Department of General Neurology, University of Muenster, Germany
Annette Baumgärtner, PhD
Faculty of Health and Social Sciences, Fresenius University of Applied Sciences, Hamburg, Germany

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

Response: For a long time, it has been assumed that language recovery is limited to the first months after the initial stroke. During the past two decades, however, several clinical studies and systematic reviews have challenged this dogma by demonstrating functional gains in stroke survivors during the chronic post-stroke stage (at least 6 months post the initial stroke) whenever speech and language therapy (SLT) intensity was sufficiently high (i.e., at least 5 h/week for several weeks). These studies, however, lacked the methodological quality required for evidence-based interventions (for criteria, please refer to http://www.cebm.net/ocebm-levels-of-evidence). Until now, this lack in evidence severely hampers stroke survivors’ access to language rehabilitation services .

The present multicenter randomized controlled healthcare trial FCET2EC (acronym stands for “From Controlled Experimental Trial to=2 Everyday Communication) is the first study worldwide to compare three weeks of intensive SLT provided under routine clinical conditions to an equally long period of no (or low intensity) SLT. After 3 weeks of intensive individualized therapy, the 156 stroke survivors with chronic aphasia verbally expressed themselves more effectively in daily-life communicative situations, like changing a doctor’s appointment by a telephone call. Additionally, patients and their significant other rated their communication-related quality of life as significantly improved.

Last but not least, therapy effects remained stable over a follow-up period of six months after the intensive intervention.

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Vitamin D During Fetal Life and Bone Health in Children at Age 6

MedicalResearch.com Interview with:
Audry H. Garcia PhD

Scientist Department of Epidemiology
Erasmus MC, University Medical Center Rotterdam
Rotterdam, the Netherlands 

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

Response: Fetal bone mineralisation requires an adequate transfer of calcium to the fetus by the end of the pregnancy. Considering that vitamin D is required to maintain normal blood concentrations of calcium, adequate 25-hydroxyvitamin D (25[OH]D) concentrations in pregnant women seem to be crucial for bone development of the offspring. Maternal vitamin D deficiency during pregnancy has been associated with abnormal early skeletal growth in offspring and might be a risk factor for decreased bone mass in later life. Several studies have linked vitamin D deficiency in fetal life to congenital rickets, craniotabes, wide skull sutures and osteomalacia. However, the evidence of long-lasting effects of maternal vitamin D deficiency during pregnancy on offspring’s skeletal development is scarce and inconsistent, and has led to contradictory recommendations on vitamin D supplementation during pregnancy.

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Safety and Immunogenicity of the Tau Vaccine AADvac1 in Patients with Alzheimer’s Disease

MedicalResearch.com Interview with:

Petr Novak, MD, PhD AXON Neuroscience Bratislava, Slovakia

Dr. Petr Novak

Petr Novak, MD, PhD
AXON Neuroscience
Bratislava, Slovakia

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

Response: Alzheimer’s disease is a complex, multifactorial disorder, with many-faceted neuropathology. A hallmark finding is the co-existence of neurofibrillary pathology (such as neurofibrillary tangles) composed of tau protein, and amyloid-β pathology (plaques) [1].

Neurofibrillary pathology is closely correlated with cognitive impairment in Alzheimer’s disease [2], while support for the role amyloid in the disease pathogenesis comes from the ability of certain mutations to induce AD in an autosomal-dominant fashion [3].

The field has explored various anti-amyloid therapies to great extent, and continues to do so with undiminished effort [4]; meanwhile, there is a noticeable paucity of investigated therapies aimed at neurofibrillary tau protein pathology, despite the ability of tau protein dysfunction to cause a multitude of neurodegenerative disorders, collectively named “tauopathies” [5].

AADvac1 is the first tau-targeted immunotherapy investigated in humans [6], a pioneering effort to target the component of AD neuropathology that is proximal to neuronal damage and cognitive loss, and thus to halt or slow the progression of Alzheimer’s disease.

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Subtle Differences in Brain Volume Detected On MRI In ADHD

MedicalResearch.com Interview with:
M. (Martine) Hoogman PhD.

Postdoc and PI of ENIGMA-ADHD
Radboud universitair medisch centrum
Department of Human Genetics
Nijmegen, The Netherlands

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

Response: There are many neuro-imaging studies aimed at investigating structural brain changes related to ADHD, but the results are often inconclusive.

There are two main reasons for this:

1) the small sample size of the studies and
2) the heterogeneous methods used.

We tried to address these issues by forming an international collaboration to provide a sample size sufficient to detect even small effects in volume differences. And in addition, we analyzed all the raw scans again using homogenized methods. There are data of more than 1700 patients (aged 4-63 years of age) and more than 1500 healthy controls in our dataset, coming from 23 sites around the world. We studied the possible volume differences between cases and controls of 7 subcortical regions and intracranial volume by performing mega- and meta-analysis.

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Money for Medication Improved Adherence To Medications for Psychosis

MedicalResearch.com Interview with:

 Ernst L Noordraven MSc, PhD student Department of Psychiatry Epidemiological and Social Psychiatric Research institute Erasmus University Medical Center Rotterdam Netherlands

Ernst L Noordraven

Ernst L Noordraven MSc, PhD student
Department of Psychiatry
Epidemiological and Social Psychiatric Research institute
Erasmus University Medical Center
Rotterdam Netherlands

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

Response: Provision of financial incentives is a promising intervention for improving adherence in patients taking antipsychotic medication. We aimed to assess the effectiveness of this intervention for improving adherence to antipsychotic depot medication in patients with psychotic disorders, irrespective of their previous compliance.

Our 12-month randomized controlled trial showed that financial incentives improved adherence to antipsychotic depot medications in patients with psychotic disorders, regardless of their level of compliance at study entrance. Patients received either treatment as usual plus a financial reward for each depot of medication received (€30 per month if fully compliant; intervention group) or treatment as usual alone (control group). Based on the use of depot registrations from 155 patients (92%), the adjusted difference in adherence was 14·9% (95% CI 8·9–20·9%; p<0·0001) in favour of the intervention group.

Our study is also the first to demonstrate that the effects on medication adherence persist after monetary rewards are discontinued, for at least a 6-month follow-up period (adjusted difference 6·5%, 95% CI 2·0–10·9; p=0·047).

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Educating Religious Leaders Improves Uptake of Male Circumcision in Tanzania

MedicalResearch.com Interview with:

Jennifer A. Downs, M.D., Ph.D. Assistant Professor of Medicine and Microbiology & Immunology Department of Medicine Weill Cornell Medicine Center for Global Health New York, NY 10065

Dr. Jennifer Downs

Jennifer A. Downs, M.D., Ph.D.
Assistant Professor of Medicine and Microbiology & Immunology
Department of Medicine
Weill Cornell Medicine
Center for Global Health
New York, NY 10065

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

Response: Between 2002 and 2006, three large randomized controlled trials in sub-Saharan Africa demonstrated that male circumcision reduces new HIV infections in men by approximately 60%. Based on these findings, the World Health Organization recommended male circumcision as an HIV prevention strategy in countries with high levels of HIV and a low prevalence of male circumcision. This led to prioritization of 14 countries in Eastern and Southern Africa for massive scale-up of male circumcision beginning in 2011.

In many of these countries, the uptake of male circumcision was lower than expected. In northwest Tanzania, where we work, there are a number of barriers to male circumcision. Some of these barriers are cultural, tribal, economic, and religious. We conducted focus group interviews in 2012 that showed that many Christian church leaders and church attenders in our region in Tanzania had major concerns about whether male circumcision was compatible with their religious beliefs. This led us to hypothesize that the uptake of male circumcision could be increased when religious leaders were taught about male circumcision, with the goal that they would then be equipped to discuss this issue with their congregations.
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Vitamin D May Have Protective Role Against Respiratory Infections

MedicalResearch.com Interview with:
Dr. Adrian R Martineau
B Med Sci DTM&H MRCP PhD
Clinical Professor of Respiratory Infection and Immunity
Centre for Primary Care and Public Health.
Blizard Institute, Barts and The London School of Medicine and Dentistry
Queen Mary, University of London

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

Response: In addition to its well-known effects on bone, Vitamin D has also been shown to boost immune responses to viruses and bacteria that cause respiratory infections in lab experiments.

In order to see whether these effects translate into a health benefit, a total of 25 clinical trials of vitamin D supplementation to prevent various respiratory infections have been carried out in around 11,000 people living in 14 different countries over the last decade.

These trials have yielded conflicting results: in some, vitamin D reduced the risk of infections, but in others it did not.

The reason why vitamin D ‘worked’ in some trials, but not in others, has been the subject of much debate.

In order to answer this question, we assembled an international consortium of investigators and compiled the raw data from every trial into a single database containing information from 10,933 people in total. This allowed us to run sub-group analyses to determine whether particular groups of people benefit more from vitamin D supplementation than others.

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